An interventional study of Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation and Arthroscopic rotator cuff repair in Rotator Cuff Injuries, sponsored by Smith & Nephew, Inc.. Terminated at 30 sites in 8 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Smith & Nephew, Inc. · Not applicable, Interventional, and Treatment
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 119 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Procedure: Arthroscopic rotator cuff repair
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Device: Arthroscopic rotator cuff repair for revision surgery
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
Retear Rate at 6 Months
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Time frame: 6 months
Number of Retears at 3 Months, 12 Months, and 24 Months
Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Time frame: 3 months, 12 months, and 24 months
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Constant-Murley Score
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Subjective Shoulder Value (SSV)
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Medical Care
The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not
Time frame: 3 months, 6 months, 12 months and 24 months
Pain - Visual Analog Scale (VAS) Score
Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
MRI Tendon Findings: Supraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Supraspinatus Goutallier Classification
Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Goutallier Classification
Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Time frame: 3 months, 6 months, 12 months and 24 months
Total Tendon Thickness
Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
Time frame: 3 months, 6 months, 12 months and 24 months
Total Tendon Length
Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
Time frame: 3 months, 6 months, 12 months and 24 months
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Size of Retear: Anteroposterior (AP) Length
Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Size of Retear: Mediolateral (ML) Length
Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Shape of Retear: Operative Visit
Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine
Time frame: Day 0
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine
Time frame: 3 months, 6 months, 12 months and 24 months
Return to Work Questionnaire
Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
Return to Work Questionnaire: Reason for Not Getting Back to Work
The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Reason Couldn't Return to Activities
The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Time Off
Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Duration Away From Work (Days)
Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Duration of Opioid Use
Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Time frame: Following surgery, up to 14 days
Opioid Use for More Than 5 Days Post-Surgery
Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Time frame: Following surgery, up to 14 days
Total Operative Time
Total operative time in minutes.
Time frame: Intraoperative
Sling Type
The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing
Time frame: up to 3 months
Mobilization Time in Sling
Mobilization time was the duration, measured in weeks, that participants spent in a sling.
Time frame: up to 3 months
Overall, 119 participants were enrolled to the study at 15 sites.
| Milestone | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Started | 47 | 48 | 24 |
| Completed | 10 | 14 | 12 |
| Not completed | 37 | 34 | 12 |
| Withdrew: Adverse event | 1 | 1 | 0 |
| Withdrew: Device not used | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject & study terminated by sponsor | 1 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Protocol deviation | 0 | 1 | 0 |
| Withdrew: Reoperation | 1 | 1 | 0 |
| Withdrew: Screen failures | 0 | 0 | 2 |
| Withdrew: Site terminated by sponsor | 1 | 1 | 1 |
| Withdrew: Study terminated by sponsor | 31 | 29 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 |
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
| percentage of retears | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Retear Rate at 6 Months | 57.14 (40.96 to 72.28) | 50.00 (34.19 to 65.81) | 42.11 (20.25 to 66.50) |
Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months | 12 | 10 | 6 |
| 12 months | 7 | 6 | — |
| 24 months | 1 | 1 | — |
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 33.1 ± 7.7 | 34.0 ± 7.5 | 29.5 ± 7.8 |
| 3 months | 25.1 ± 8.0 | 29.4 ± 9.7 | 23.4 ± 9.6 |
| 6 months | 18.9 ± 6.6 | 19.9 ± 7.9 | 18.9 ± 7.6 |
| 12 months | 18.8 ± 8.5 | 17.3 ± 7.9 | — |
| 24 months | 19.0 ± 7.1 | 15.0 ± 4.2 | — |
The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 1271.3 ± 366.6 | 1307.5 ± 398.7 | 1194.0 ± 427.6 |
| 3 months | 860.7 ± 350.1 | 936.7 ± 472.4 | 703.9 ± 365.1 |
| 6 months | 533.6 ± 429.5 | 540.1 ± 475.1 | 548.8 ± 493.4 |
| 12 months | 432.8 ± 453.7 | 405.6 ± 596.5 | — |
| 24 months | 281.5 ± 252.4 | 62.5 ± 81.3 | — |
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 56.5 ± 13.5 | 54.9 ± 13.7 | 55.6 ± 16.8 |
| 3 months | — | 55.0 ± NA | 43.4 ± NA |
| 6 months | 57.0 ± 13.0 | 53.7 ± 12.3 | 53.4 ± 9.4 |
| 12 months | 59.1 ± 13.8 | 57.2 ± 10.7 | — |
| 24 months | 58.5 ± 3.5 | 51.0 ± 11.3 | — |
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 38.3 ± 21.6 | 38.1 ± 24.6 | 47.1 ± 22.7 |
| 3 months | 60.1 ± 21.0 | 57.1 ± 20.8 | 72.5 ± 16.8 |
| 6 months | 74.1 ± 17.7 | 77.3 ± 20.6 | 76.3 ± 21.4 |
| 12 months | 80.0 ± 14.9 | 88.9 ± 10.2 | — |
| 24 months | 77.5 ± 24.7 | 91.5 ± 9.2 | — |
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 0.618 ± 0.186 | 0.574 ± 0.229 | 0.597 ± 0.216 |
| 3 months | 0.720 ± 0.194 | 0.649 ± 0.206 | 0.776 ± 0.173 |
| 6 months | 0.781 ± 0.216 | 0.786 ± 0.232 | 0.834 ± 0.165 |
| 12 months | 0.719 ± 0.227 | 0.805 ± 0.256 | — |
| 24 months | 0.679 ± 0.200 | 0.919 ± 0.115 | — |
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 73.4 ± 15.4 | 69.8 ± 17.5 | 65.3 ± 23.1 |
| 3 months | 74.2 ± 15.7 | 73.0 ± 16.4 | 80.3 ± 20.5 |
| 6 months | 82.5 ± 15.4 | 79.3 ± 19.0 | 73.5 ± 21.8 |
| 12 months | 75.1 ± 16.6 | 75.0 ± 15.2 | — |
| 24 months | 30.0 ± 28.3 | 87.5 ± 3.5 | — |
The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Baseline | 88.6 ± 19.8 | 94.3 ± 8.3 | 89 ± 19.2 |
| 3 months | 88.8 ± 13.7 | 93.1 ± 13.3 | 89.2 ± 27.3 |
| 6 months | 89.7 ± 19.9 | 93.6 ± 16.6 | 90.8 ± 23.4 |
| 12 months | 91.5 ± 11.3 | 94.4 ± 9 | — |
| 24 months | 90 ± NA | 90 ± NA | — |
The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Excellent | 7 | 9 | 5 |
| 3 months — Very Good | 11 | 7 | 5 |
| 3 months — Good | 11 | 4 | 1 |
| 3 months — Fair | 3 | 6 | 2 |
| 3 months — Poor | 2 | 3 | 1 |
| 6 months — Excellent | 15 | 18 | 10 |
| 6 months — Very Good | 17 | 13 | 6 |
| 6 months — Good | 8 | 4 | 2 |
| 6 months — Fair | 1 | 4 | 1 |
| 6 months — Poor | 1 | 4 | 1 |
| 12 months — Excellent | 5 | 6 | — |
| 12 months — Very Good | 4 | 1 | — |
| 12 months — Good | 1 | 1 | — |
| 12 months — Fair | 0 | 1 | — |
| 12 months — Poor | 2 | 0 | — |
| 24 months — Excellent | 1 | 1 | — |
| 24 months — Very Good | 0 | 1 | — |
| 24 months — Good | 1 | 0 | — |
| 24 months — Fair | 0 | 0 | — |
| 24 months — Poor | 0 | 0 | — |
The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Excellent | 5 | 1 | 1 |
| 3 months — Very Good | 6 | 7 | 8 |
| 3 months — Good | 14 | 6 | 1 |
| 3 months — Fair | 4 | 9 | 2 |
| 3 months — Poor | 5 | 6 | 2 |
| 6 months — Excellent | 13 | 8 | 8 |
| 6 months — Very Good | 16 | 21 | 6 |
| 6 months — Good | 9 | 7 | 3 |
| 6 months — Fair | 3 | 3 | 1 |
| 6 months — Poor | 1 | 4 | 2 |
| 12 months — Excellent | 5 | 6 | — |
| 12 months — Very Good | 3 | 1 | — |
| 12 months — Good | 2 | 2 | — |
| 12 months — Fair | 1 | 0 | — |
| 12 months — Poor | 1 | 0 | — |
| 24 months — Excellent | 1 | 2 | — |
| 24 months — Very Good | 0 | 0 | — |
| 24 months — Good | 1 | 0 | — |
| 24 months — Fair | 0 | 0 | — |
| 24 months — Poor | 0 | 0 | — |
The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Excellent | 0 | 1 | 1 |
| 3 months — Very Good | 3 | 4 | 5 |
| 3 months — Good | 10 | 1 | 2 |
| 3 months — Fair | 9 | 9 | 3 |
| 3 months — Poor | 10 | 13 | 3 |
| 6 months — Excellent | 7 | 1 | 3 |
| 6 months — Very Good | 10 | 20 | 6 |
| 6 months — Good | 14 | 6 | 4 |
| 6 months — Fair | 7 | 9 | 2 |
| 6 months — Poor | 3 | 7 | 5 |
| 12 months — Excellent | 2 | 5 | — |
| 12 months — Very Good | 6 | 2 | — |
| 12 months — Good | 1 | 1 | — |
| 12 months — Fair | 2 | 1 | — |
| 12 months — Poor | 1 | 0 | — |
| 24 months — Excellent | 0 | 1 | — |
| 24 months — Very Good | 1 | 1 | — |
| 24 months — Good | 1 | 0 | — |
| 24 months — Fair | 0 | 0 | — |
| 24 months — Poor | 0 | 0 | — |
The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Excellent | 11 | 8 | 8 |
| 3 months — Very Good | 8 | 9 | 3 |
| 3 months — Good | 9 | 7 | 0 |
| 3 months — Fair | 4 | 3 | 1 |
| 3 months — Poor | 1 | 2 | 2 |
| 6 months — Excellent | 17 | 17 | 7 |
| 6 months — Very Good | 11 | 13 | 5 |
| 6 months — Good | 10 | 6 | 3 |
| 6 months — Fair | 2 | 4 | 1 |
| 6 months — Poor | 2 | 3 | 4 |
| 12 months — Excellent | 5 | 6 | — |
| 12 months — Very Good | 3 | 1 | — |
| 12 months — Good | 1 | 2 | — |
| 12 months — Fair | 2 | 0 | — |
| 12 months — Poor | 1 | 0 | — |
| 24 months — Excellent | 1 | 1 | — |
| 24 months — Very Good | 0 | 1 | — |
| 24 months — Good | 1 | 0 | — |
| 24 months — Fair | 0 | 0 | — |
| 24 months — Poor | 0 | 0 | — |
The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Definitely Yes | 20 | 18 | 11 |
| 3 months — Probably Yes | 11 | 7 | 2 |
| 3 months — Possibly Not | 2 | 0 | 1 |
| 3 months — Definitely Not | 1 | 4 | 0 |
| 6 months — Definitely Yes | 22 | 25 | 10 |
| 6 months — Probably Yes | 14 | 12 | 7 |
| 6 months — Possibly Not | 5 | 4 | 2 |
| 6 months — Definitely Not | 1 | 2 | 1 |
| 12 months — Definitely Yes | 6 | 6 | — |
| 12 months — Probably Yes | 3 | 1 | — |
| 12 months — Possibly Not | 2 | 1 | — |
| 12 months — Definitely Not | 1 | 1 | — |
| 24 months — Definitely Yes | 2 | 1 | — |
| 24 months — Probably Yes | 0 | 1 | — |
| 24 months — Possibly Not | 0 | 0 | — |
| 24 months — Definitely Not | 0 | 0 | — |
Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
| score on a scale | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 2 weeks | 31.2 ± 27.7 | 27.4 ± 26.6 | 21.6 ± 25.8 |
| 6 weeks | 21.5 ± 24.3 | 24 ± 26.5 | 19.3 ± 23.8 |
| 3 months | — | 20 ± NA | 2 ± NA |
| 6 months | 10.4 ± 18 | 8 ± 17.9 | 9.2 ± 18.6 |
The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Type I | 1 | 0 | 0 |
| 3 months — Type II | 17 | 15 | 3 |
| 3 months — Type III | 1 | 0 | 0 |
| 3 months — Type IV | 0 | 0 | 0 |
| 3 months — Type V | 12 | 10 | 6 |
| 3 months — Indeterminate | 0 | 0 | 0 |
| 6 months — Type I | 0 | 0 | 0 |
| 6 months — Type II | 17 | 21 | 11 |
| 6 months — Type III | 1 | 0 | 0 |
| 6 months — Type IV | 3 | 1 | 0 |
| 6 months — Type V | 21 | 18 | 7 |
| 6 months — Indeterminate | 0 | 0 | 0 |
| 12 months — Type I | 0 | 0 | — |
| 12 months — Type II | 6 | 3 | — |
| 12 months — Type III | 0 | 0 | — |
| 12 months — Type IV | 2 | 1 | — |
| 12 months — Type V | 5 | 5 | — |
| 12 months — Indeterminate | 0 | 0 | — |
| 24 months — Type I | 0 | 0 | — |
| 24 months — Type II | 1 | 1 | — |
| 24 months — Type III | 0 | 0 | — |
| 24 months — Type IV | 1 | 0 | — |
| 24 months — Type V | 0 | 1 | — |
| 24 months — Indeterminate | 0 | 0 | — |
The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Type I | 1 | 0 | 0 |
| 3 months — Type II | 23 | 20 | 5 |
| 3 months — Type III | 0 | 0 | 0 |
| 3 months — Type IV | 0 | 0 | 0 |
| 3 months — Type V | 7 | 5 | 4 |
| 3 months — Indeterminate | 0 | 0 | 0 |
| 6 months — Type I | 1 | 0 | 0 |
| 6 months — Type II | 27 | 31 | 14 |
| 6 months — Type III | 0 | 0 | 0 |
| 6 months — Type IV | 1 | 0 | 0 |
| 6 months — Type V | 13 | 9 | 4 |
| 6 months — Indeterminate | 0 | 0 | 0 |
| 12 months — Type I | 1 | 0 | — |
| 12 months — Type II | 8 | 6 | — |
| 12 months — Type III | 0 | 0 | — |
| 12 months — Type IV | 0 | 0 | — |
| 12 months — Type V | 4 | 3 | — |
| 12 months — Indeterminate | 0 | 0 | — |
| 24 months — Type I | 0 | 0 | — |
| 24 months — Type II | 2 | 1 | — |
| 24 months — Type III | 0 | 0 | — |
| 24 months — Type IV | 0 | 0 | — |
| 24 months — Type V | 0 | 1 | — |
| 24 months — Indeterminate | 0 | 0 | — |
Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Grade 0 | 6 | 3 | 1 |
| 3 months — Grade 1 | 22 | 16 | 8 |
| 3 months — Grade 2 | 2 | 4 | 1 |
| 3 months — Grade 3 | 0 | 1 | 0 |
| 3 months — Grade 4 | 0 | 1 | 0 |
| 3 months — Unable to assess | 0 | 0 | 0 |
| 6 months — Grade 0 | 5 | 5 | 1 |
| 6 months — Grade 1 | 30 | 23 | 15 |
| 6 months — Grade 2 | 6 | 7 | 1 |
| 6 months — Grade 3 | 0 | 2 | 0 |
| 6 months — Grade 4 | 0 | 2 | 1 |
| 6 months — Unable to assess | 0 | 0 | 0 |
| 12 months — Grade 0 | 1 | 1 | — |
| 12 months — Grade 1 | 10 | 4 | — |
| 12 months — Grade 2 | 2 | 2 | — |
| 12 months — Grade 3 | 0 | 1 | — |
| 12 months — Grade 4 | 0 | 1 | — |
| 12 months — Unable to assess | 0 | 0 | — |
| 24 months — Grade 0 | 0 | 1 | — |
| 24 months — Grade 1 | 2 | 0 | — |
| 24 months — Grade 2 | 0 | 0 | — |
| 24 months — Grade 3 | 0 | 1 | — |
| 24 months — Grade 4 | 0 | 0 | — |
| 24 months — Unable to assess | 0 | 0 | — |
Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Grade 0 | 3 | 6 | 1 |
| 3 months — Grade 1 | 16 | 13 | 3 |
| 3 months — Grade 2 | 8 | 3 | 5 |
| 3 months — Grade 3 | 2 | 2 | 1 |
| 3 months — Grade 4 | 0 | 1 | 0 |
| 3 months — Unable to assess | 0 | 0 | 0 |
| 6 months — Grade 0 | 3 | 9 | 1 |
| 6 months — Grade 1 | 19 | 19 | 10 |
| 6 months — Grade 2 | 13 | 7 | 6 |
| 6 months — Grade 3 | 4 | 3 | 1 |
| 6 months — Grade 4 | 1 | 2 | 0 |
| 6 months — Unable to assess | 0 | 0 | 0 |
| 12 months — Grade 0 | 1 | 1 | — |
| 12 months — Grade 1 | 7 | 6 | — |
| 12 months — Grade 2 | 4 | 1 | — |
| 12 months — Grade 3 | 1 | 0 | — |
| 12 months — Grade 4 | 0 | 1 | — |
| 12 months — Unable to assess | 0 | 0 | — |
| 24 months — Grade 0 | 0 | 1 | — |
| 24 months — Grade 1 | 1 | 0 | — |
| 24 months — Grade 2 | 1 | 0 | — |
| 24 months — Grade 3 | 0 | 0 | — |
| 24 months — Grade 4 | 0 | 1 | — |
| 24 months — Unable to assess | 0 | 0 | — |
Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
| millimeters (mm) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months | 5.6 ± 1.4 | 5.4 ± 1.1 | 6.2 ± 1.5 |
| 6 months | 5.9 ± 1.2 | 5.5 ± 1 | 5.7 ± 1.1 |
| 12 months | 4.9 ± 1 | 5.5 ± 0.6 | — |
| 24 months | 5 ± 0.3 | — | — |
Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
| millimeters (mm) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months | 36.4 ± 9.3 | 32.6 ± 11.3 | 40.2 ± 1.3 |
| 6 months | 34.7 ± 9.6 | 33.9 ± 10.4 | 38.2 ± 4 |
| 12 months | 33.6 ± 10.3 | 29.6 ± 13 | — |
| 24 months | 49.1 ± NA | 19.9 ± 13.6 | — |
Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
| millimeters squared (mm^2) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Day 0 | 1041.7 ± 482.7 | 1004 ± 448.5 | 877.1 ± 218.3 |
| 3 months | 1173.2 ± 698.5 | 1099.6 ± 554.1 | 1158.2 ± 790.8 |
| 6 months | 1000.6 ± 699.2 | 1203.0 ± 624.3 | 1159.6 ± 1022.3 |
Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
| millimeters (mm) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Day 0 | 32.1 ± 7.2 | 31.8 ± 7.4 | 30 ± 8.2 |
| 3 months | 29.9 ± 12.5 | 30.7 ± 9.8 | 28.1 ± 14.0 |
| 6 months | 27.4 ± 12.1 | 29.9 ± 10.9 | 26.8 ± 14.3 |
Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
| millimeters (mm) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Day 0 | 31.7 ± 8.7 | 31.7 ± 11.4 | 29.4 ± 1.5 |
| 3 months | 36.9 ± 8.9 | 33.6 ± 11.4 | 37.6 ± 11.1 |
| 6 months | 32.1 ± 12.8 | 37.1 ± 13.2 | 38.1 ± 16.4 |
Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Crescent | 12 | 8 | 7 |
| L Shape | 2 | 7 | 0 |
| Reverse L | 1 | 2 | 2 |
| U Shape | 6 | 4 | 3 |
| Massive/Contracted | 5 | 3 | 1 |
| Unable to Determine | 0 | 0 | 0 |
Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 3 months — Intact (i.e., no re-tear) | 18 | 14 | 3 |
| 3 months — Crescent | 1 | 2 | 0 |
| 3 months — Longitudinal | 4 | 1 | 2 |
| 3 months — Massive | 8 | 8 | 4 |
| 3 months — Unable to Assess | 0 | 0 | 1 |
| 6 months — Intact (i.e., no re-tear) | 16 | 21 | 10 |
| 6 months — Crescent | 3 | 0 | 1 |
| 6 months — Longitudinal | 5 | 4 | 4 |
| 6 months — Massive | 18 | 14 | 3 |
| 6 months — Unable to Assess | 0 | 1 | 0 |
| 12 months — Intact (i.e., no re-tear) | 5 | 3 | — |
| 12 months — Crescent | 0 | 0 | — |
| 12 months — Longitudinal | 3 | 2 | — |
| 12 months — Massive | 4 | 4 | — |
| 12 months — Unable to Assess | 1 | 0 | — |
| 24 months — Intact (i.e., no re-tear) | 1 | 1 | — |
| 24 months — Crescent | 1 | 0 | — |
| 24 months — Longitudinal | 0 | 0 | — |
| 24 months — Massive | 0 | 1 | — |
| 24 months — Unable to Assess | 0 | 0 | — |
Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 2 weeks: Returned to work? — Yes | 7 | 5 | 3 |
| 2 weeks: Returned to work? — No | 18 | 20 | 8 |
| 6 weeks: Returned to work? — Yes | 1 | 3 | 3 |
| 6 weeks: Returned to work? — No | 15 | 16 | 5 |
| 3 months: Returned to work? — Yes | 3 | 2 | 2 |
| 3 months: Returned to work? — No | 12 | 11 | 1 |
| 6 months: Returned to work? — Yes | 4 | 14 | 3 |
| 6 months: Returned to work? — No | 8 | 9 | 3 |
| 2 weeks: Have you been able to return to the job you did before your surgery? — Yes | 5 | 2 | 1 |
| 2 weeks: Have you been able to return to the job you did before your surgery? — No | 2 | 3 | 2 |
| 6 weeks: Have you been able to return to the job you did before your surgery? — Yes | 1 | 1 | 2 |
| 6 weeks: Have you been able to return to the job you did before your surgery? — No | 0 | 2 | 1 |
| 3 months: Have you been able to return to the job you did before your surgery? — Yes | 3 | 1 | 1 |
| 3 months: Have you been able to return to the job you did before your surgery? — No | 0 | 1 | 1 |
| 6 months: Have you been able to return to the job you did before your surgery? — Yes | 4 | 10 | 3 |
| 6 months: Have you been able to return to the job you did before your surgery? — No | 0 | 3 | 0 |
| 2 weeks: Did you feel ready to go back to work physically? — Yes | 5 | 5 | 2 |
| 2 weeks: Did you feel ready to go back to work physically? — No | 2 | 0 | 1 |
| 6 weeks: Did you feel ready to go back to work physically? — Yes | 1 | 3 | 3 |
| 6 weeks: Did you feel ready to go back to work physically? — No | 0 | 0 | 0 |
| 3 months: Did you feel ready to go back to work physically? — Yes | 3 | 1 | 2 |
| 3 months: Did you feel ready to go back to work physically? — No | 0 | 1 | 0 |
| 6 months: Did you feel ready to go back to work physically? — Yes | 4 | 12 | 2 |
| 6 months: Did you feel ready to go back to work physically? — No | 0 | 2 | 1 |
| 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? — Yes | 0 | 0 | 0 |
| 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? — No | 7 | 5 | 3 |
| 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? — Yes | 0 | 0 | 0 |
| 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? — No | 1 | 3 | 3 |
| 3 months: Since returning to work, any time off due to shoulder pain or weakness? — Yes | 0 | 0 | 0 |
| 3 months: Since returning to work, any time off due to shoulder pain or weakness? — No | 3 | 2 | 2 |
| 6 months: Since returning to work, any time off due to shoulder pain or weakness? — Yes | 0 | 1 | 1 |
| 6 months: Since returning to work, any time off due to shoulder pain or weakness? — No | 4 | 13 | 2 |
| 2 weeks: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — Yes | — | — | — |
| 2 weeks: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — No | — | — | — |
| 6 weeks: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — Yes | — | — | — |
| 6 weeks: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — No | — | — | — |
| 3 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — Yes | — | — | — |
| 3 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — No | — | — | — |
| 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — Yes | — | 1 | 0 |
| 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? — No | — | 2 | 1 |
The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 2 weeks — Physical capability | 12 | 13 | 5 |
| 2 weeks — Safety | 1 | 1 | 1 |
| 2 weeks — Motivation | 0 | 0 | 0 |
| 2 weeks — Other | 5 | 6 | 2 |
| 6 weeks — Physical capability | 11 | 12 | 4 |
| 6 weeks — Safety | 1 | 0 | 0 |
| 6 weeks — Motivation | 0 | 1 | 0 |
| 6 weeks — Other | 3 | 2 | 1 |
| 3 months — Physical capability | 7 | 8 | 1 |
| 3 months — Safety | 1 | 0 | 0 |
| 3 months — Motivation | 0 | 0 | 0 |
| 3 months — Other | 3 | 2 | 0 |
| 6 months — Physical capability | 3 | 3 | 2 |
| 6 months — Safety | 1 | 1 | 0 |
| 6 months — Motivation | 0 | 0 | 0 |
| 6 months — Other | 4 | 4 | 1 |
The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 2 weeks — Physical capability | 2 | 3 | 2 |
| 2 weeks — Safety | 0 | 0 | 0 |
| 2 weeks — Motivation | 0 | 0 | 0 |
| 2 weeks — Other | 0 | 0 | 0 |
| 6 weeks — Physical capability | — | 1 | 1 |
| 6 weeks — Safety | — | 1 | 0 |
| 6 weeks — Motivation | — | 0 | 0 |
| 6 weeks — Other | — | 0 | 0 |
| 3 months — Physical capability | — | 1 | 1 |
| 3 months — Safety | — | 0 | 0 |
| 3 months — Motivation | — | 0 | 0 |
| 3 months — Other | — | 0 | 0 |
| 6 months — Physical capability | — | 2 | — |
| 6 months — Safety | — | 0 | — |
| 6 months — Motivation | — | 0 | — |
| 6 months — Other | — | 1 | — |
Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.
| days | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 6 months | — | 8 ± NA | 2 ± NA |
Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work
| days | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| 2 weeks | 6.7 ± 3 | 7.2 ± 4.4 | 6.7 ± 5.1 |
| 6 weeks | 19 ± NA | 23 ± 4.6 | 30.3 ± 15.9 |
| 3 months | 68.3 ± 20.8 | 64.5 ± 16.3 | 52 ± 11.3 |
| 6 months | 74.5 ± 69.9 | 80.3 ± 63.8 | 75 ± 18.7 |
Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
| days | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Duration of Opioid Use | 7.9 ± 4.9 | 7.1 ± 4.5 | 6.3 ± 4.9 |
Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| No | 17 | 18 | 10 |
| Yes | 25 | 24 | 11 |
Total operative time in minutes.
| minutes | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Total Operative Time | 176.2 ± 60.9 | 138.8 ± 42.7 | 172.8 ± 47.7 |
The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing
| Participants | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Standard Sling | 13 | 17 | 5 |
| Shoulder Immobilizer | 20 | 16 | 6 |
| Sling and Swathe | 0 | 0 | 0 |
| Abduction Sling | 8 | 4 | 4 |
| External Rotation Sling | 0 | 3 | 0 |
| Other | 4 | 4 | 7 |
| Missing | 1 | 4 | 2 |
Mobilization time was the duration, measured in weeks, that participants spent in a sling.
| weeks | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Mobilization Time in Sling | 5.5 ± 1.1 | 5.4 ± 1.3 | 5.6 ± 1.1 |
Collected over Adverse events were collected during surgery to early termination, up to 24 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | 0/47 (0%) | 2/47 (4.3%) | 16/47 (34%) |
| ARCR Alone | 0/48 (0%) | 6/48 (12.5%) | 11/48 (22.9%) |
| Revision Group | 0/24 (0%) | 4/24 (16.7%) | 4/24 (16.7%) |
| Event | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| Low Blood Pressure/HypotensionGeneral disorders | 0/47 | 0/48 | 1/24 |
| Syncope/FaintingNervous system disorders | 0/47 | 0/48 | 1/24 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/47 | 0/48 | 1/24 |
| FallInjury, poisoning and procedural complications | 0/47 | 0/48 | 1/24 |
| Muscle/Tendon DamageMusculoskeletal and connective tissue disorders | 0/47 | 0/48 | 1/24 |
| Loss of Range of MotionMusculoskeletal and connective tissue disorders | 0/47 | 0/48 | 1/24 |
| Urinary RetentionRenal and urinary disorders | 1/47 | 0/48 | 0/24 |
| Myocardial InfarctionCardiac disorders | 1/47 | 0/48 | 0/24 |
| PainGeneral disorders | 1/47 | 0/48 | 0/24 |
| CellulitisSkin and subcutaneous tissue disorders | 0/47 | 1/48 | 0/24 |
| Event | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 5/47 | 1/48 | 0/24 |
| Swelling/EdemaGeneral disorders | 2/47 | 1/48 | 0/24 |
| PainGeneral disorders | 0/47 | 1/48 | 1/24 |
| Peripheral Nervous InjuryNervous system disorders | 0/47 | 0/48 | 1/24 |
| Urinary Tract InfectionRenal and urinary disorders | 0/47 | 0/48 | 1/24 |
| ConstipationGastrointestinal disorders | 1/47 | 0/48 | 1/24 |
| Unspecified InfectionInfections and infestations | 0/47 | 2/48 | 0/24 |
| Low Oxygen SaturationInvestigations | 0/47 | 0/48 | 1/24 |
| Urinary FrequencyRenal and urinary disorders | 0/47 | 0/48 | 1/24 |
| PainGeneral disorders | 1/47 | 1/48 | 1/24 |
The safety analysis set (SAF) included all participants that received the study device with data collected.
| Age, Continuous(years) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Mean | 62.3 ± 7.6 | 62.2 ± 8.7 | 58.3 ± 9.2 | 61.5 ± 8.5 |
| Sex: Female, Male(Participants) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Female | 16 | 21 | 5 | 42 |
| Male | 31 | 27 | 19 | 77 |
| Ethnicity (NIH/OMB)(Participants) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 0 | 6 |
| Not Hispanic or Latino | 40 | 41 | 21 | 102 |
| Unknown or Not Reported | 3 | 5 | 3 | 11 |
| Race/Ethnicity, Customized(Participants) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Race — White / Caucasian | 43 | 37 | 22 | 102 |
| Race — Black / African American | 0 | 2 | 1 | 3 |
| Race — Asian Indian | 1 | 1 | 0 | 2 |
| Race — Chinese | 3 | 5 | 0 | 8 |
| Race — Japanese | 0 | 0 | 0 | 0 |
| Race — Korean | 0 | 0 | 0 | 0 |
| Race — Vietnamese | 0 | 0 | 0 | 0 |
| Race — Other Asian | 0 | 1 | 0 | 1 |
| Race — Aboriginal and Torres Strait Islander | 0 | 0 | 0 | 0 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Race — Other | 0 | 2 | 1 | 3 |
| Body Mass Index (BMI)(kg/m^2) | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Mean | 29.7 ± 6.0 | 29.5 ± 5.8 | 28.3 ± 5.4 | 29.3 ± 5.8 |
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