An observational study in Labral Tear, Glenoid, Acetabular Labrum Tear and Bankart Lesions, sponsored by Smith & Nephew, Inc.. Completed at 12 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Smith & Nephew, Inc. · Observational
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 315 subjects needing reattachment of soft tissue to bone.
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors.
Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's enrollment of 298 is above the median of 70 across 145 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 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.
Subject requires reattachment of soft tissue to bone for the following indications:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject requires reattachment of soft tissue to bone for one of the following indications:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MICRORAPTOR™ REGENESORB™ Suture Anchor
Device: MICRORAPTOR™ REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
Device: MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless PEEK Suture Anchor
Device: MICRORAPTOR™ Knotless PEEK Suture Anchor
Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.
The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.
Repair Failure Rate at 6 Months
Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
Time frame: 6 months
Repair Failure Rate at 12 Months
Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
Time frame: 12 months
Visual Analogue Scale (VAS) Pain Change From Baseline
Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity. Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome). A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome). The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)
Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor. Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
Time frame: 24 months
Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following: * Normal Intact Labrum * Labral Tear / Degeneration
Time frame: Baseline, 6 months, and 24 months
Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following: * None * Mild * Moderate * Severe
Time frame: Baseline, 6 months, and 24 months
Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema. The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
Time frame: Baseline, 6 months, and 24 months
Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)
The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =\< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)
Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)
Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)
The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)
Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
Time frame: Baseline to 6 months, 12 months, and 24 months
| Milestone | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Started | 114 | 122 | 61 |
| Completed | 79 | 75 | 43 |
| Not completed | 35 | 47 | 18 |
| Withdrew: Adverse event | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 28 | 35 | 14 |
| Withdrew: Physician decision | 1 | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 8 | 2 |
| Withdrew: Non-compliance with follow-up visits | 1 | 0 | 0 |
| Withdrew: Subject relocated | 0 | 0 | 1 |
| Withdrew: Device deficiency | 1 | 0 | 0 |
| Withdrew: Follow-up visit missed and could not be rescheduled | 0 | 1 | 0 |
Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
| proportion of participants | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Repair Failure Rate at 6 Months | 0 (95.7 to 100) | 0.93 | 0 |
Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
| proportion of participants | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Repair Failure Rate at 12 Months | 0 | 0 | 0 |
Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity. Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome). A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome). The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | -35.02 ± 30.02 | -31.17 ± 27.39 | -30.61 ± 24.75 |
| Baseline to 12 months | -36.22 ± 28.10 | -33.91 ± 29.68 | -28.14 ± 27.81 |
| Baseline to 24 months | — | -35.54 ± 29.28 | — |
Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor. Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
| proportion of participants | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor |
|---|---|
| Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY) | 0 |
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following: * Normal Intact Labrum * Labral Tear / Degeneration
| Participants | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor |
|---|---|
| Baseline — Normal Intact Labrum | 5 |
| Baseline — Labral Tear / Degeneration | 32 |
| 6 months — Normal Intact Labrum | 3 |
| 6 months — Labral Tear / Degeneration | 42 |
| 24 months — Normal Intact Labrum | 13 |
| 24 months — Labral Tear / Degeneration | 16 |
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following: * None * Mild * Moderate * Severe
| Participants | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor |
|---|---|
| Baseline — None | 9 |
| Baseline — Mild | 0 |
| Baseline — Moderate | 1 |
| Baseline — Severe | 0 |
| 6 months — None | 5 |
| 6 months — Mild | 5 |
| 6 months — Moderate | 0 |
| 6 months — Severe | 0 |
| 24 months — None | 3 |
| 24 months — Mild | 3 |
| 24 months — Moderate | 0 |
| 24 months — Severe | 0 |
Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema. The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
| Participants | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor |
|---|---|
| Baseline — Absent | 9 |
| Baseline — Present | 1 |
| 6 months — Absent | 5 |
| 6 months — Present | 5 |
| 24 months — Absent | 4 |
| 24 months — Present | 1 |
The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =\< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | 30.43 ± 21.40 | 40.0 ± 21.17 | 37.5 ± 20.82 |
| Baseline to 12 months | 34.43 ± 22.06 | 43.05 ± 21.06 | 44.74 ± 28.26 |
| Baseline to 24 months | — | 48.64 ± 18.93 | — |
Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | -925.68 ± 500.71 | -792.94 ± 505.37 | -719.44 ± 393.45 |
| Baseline to 12 months | -988.43 ± 453.91 | -989.85 ± 483.85 | -927.06 ± 511.32 |
| Baseline to 24 months | — | -1110.03 ± 447.06 | — |
Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | 26.11 ± 19.07 | 23.60 ± 24.78 | 17.14 ± 25.98 |
| Baseline to 12 months | 32.31 ± 12.91 | 29.78 ± 20.47 | 30.18 ± 25.85 |
| Baseline to 24 months | — | 38.53 ± 22.26 | — |
The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | 20.03 ± 16.29 | 26.20 ± 16.93 | 21.11 ± 14.44 |
| Baseline to 12 months | 22.19 ± 16.88 | 25.91 ± 18.50 | 23.00 ± 13.20 |
| Baseline to 24 months | — | 25.95 ± 16.71 | — |
Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
| score on a scale | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| Baseline to 6 months | 17.28 ± 17.23 | 25.88 ± 19.56 | 21.54 ± 15.76 |
| Baseline to 12 months | 23.60 ± 17.50 | 24.56 ± 17.40 | 17.79 ± 14.35 |
| Baseline to 24 months | — | 25.05 ± 19.01 | — |
Collected over Adverse events were collected during surgery to study completion, approximately 12 months. The MICRORAPTOR™ Knotless PEEK Suture Anchor group collected adverse events for an additional 12 months (i.e., adverse events were collected during surgery to approximately 24 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MICRORAPTOR™ REGENESORB™ Suture Anchor | 0/114 (0%) | 6/114 (5.3%) | 37/114 (32.5%) |
| MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | 0/122 (0%) | 7/122 (5.7%) | 35/122 (28.7%) |
| MICRORAPTOR™ Knotless PEEK Suture Anchor | 0/61 (0%) | 2/61 (3.3%) | 13/61 (21.3%) |
| Event | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| UNSPECIFIED GASTROINTESTINAL PROBLEMGastrointestinal disorders | 0/114 | 0/122 | 1/61 |
| CELLULITISSkin and subcutaneous tissue disorders | 0/114 | 2/122 | 0/61 |
| PAINGeneral disorders | 1/114 | 1/122 | 1/61 |
| MUSCLE/TENDON DAMAGEMusculoskeletal and connective tissue disorders | 1/114 | 0/122 | 0/61 |
| OSSIFICATIONMusculoskeletal and connective tissue disorders | 1/114 | 0/122 | 0/61 |
| UNSPECIFIED MUSCULOSKELETAL PROBLEMMusculoskeletal and connective tissue disorders | 1/114 | 0/122 | 0/61 |
| IMPLANT PAINInjury, poisoning and procedural complications | 1/114 | 0/122 | 0/61 |
| INADEQUATE PAIN RELIEFInjury, poisoning and procedural complications | 1/114 | 0/122 | 0/61 |
| ISCHEMIC HEART DISEASECardiac disorders | 0/114 | 1/122 | 0/61 |
| ARTHRITISMusculoskeletal and connective tissue disorders | 0/114 | 1/122 | 0/61 |
| Event | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor |
|---|---|---|---|
| PAINGeneral disorders | 11/114 | 10/122 | 2/61 |
| UNSPECIFIED MUSCULOSKELETAL PROBLEMMusculoskeletal and connective tissue disorders | 5/114 | 1/122 | 1/61 |
| BONE FRACTURE(S)Musculoskeletal and connective tissue disorders | 0/114 | 1/122 | 2/61 |
| NAUSEAGastrointestinal disorders | 3/114 | 0/122 | 0/61 |
| INFLAMMATIONGeneral disorders | 3/114 | 2/122 | 0/61 |
| LOSS OF RANGE OF MOTIONMusculoskeletal and connective tissue disorders | 0/114 | 3/122 | 0/61 |
| NUMBNESSNervous system disorders | 2/114 | 0/122 | 0/61 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 2/114 | 0/122 | 1/61 |
| CRAMP(S) /MUSCLE SPASM(S)Musculoskeletal and connective tissue disorders | 2/114 | 0/122 | 0/61 |
| HEADACHEGeneral disorders | 1/114 | 0/122 | 1/61 |
| Age, Continuous(years) | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor | Total |
|---|---|---|---|---|
| Mean | 40.80 ± 13.64 | 41.88 ± 14.94 | 40.16 ± 15.17 | 41.12 ± 14.44 |
| Sex: Female, Male(Participants) | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor | Total |
|---|---|---|---|---|
| Female | 68 | 65 | 32 | 165 |
| Male | 46 | 57 | 29 | 132 |
| Ethnicity (NIH/OMB)(Participants) | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 6 | 17 |
| Not Hispanic or Latino | 99 | 115 | 55 | 269 |
| Unknown or Not Reported | 9 | 2 | 0 | 11 |
| Region of Enrollment(Participants) | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor | Total |
|---|---|---|---|---|
| United States | 114 | 122 | 61 | 297 |
| Body Mass Index (BMI)(kg/m^2) | MICRORAPTOR™ REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless PEEK Suture Anchor | Total |
|---|---|---|---|---|
| Mean | 26.44 ± 4.85 | 28.63 ± 5.67 | 27.32 ± 5.05 | 27.52 ± 5.31 |
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