An interventional study of Bone Trephination and Soft Tissue Trephination in Rotator Cuff Tear, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon.
This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 176 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Medical management will be defined as:
Exclusion Criteria:
Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
Procedure: Soft Tissue Trephination
Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
Procedure: Bone Trephination
Western Ontario Rotator Cuff Index
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.
Time frame: From baseline to up until 24-Months Post-Operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Time frame: From baseline to up until 24-Months Post-Operative
The Constant Score
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
Time frame: From baseline to up until 24-Months Post-Operative
Healing Rates
Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.
Time frame: From surgery to up until 24-Months Post-Operative
| Milestone | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| Started | 47 | 41 |
| Completed | 38 | 35 |
| Not completed | 9 | 6 |
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.
| score on a scale | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| Western Ontario Rotator Cuff Index | 82 ± 25 | 80 ± 21 |
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
| score on a scale | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores | 85 ± 22 | 84 ± 17 |
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
| score on a scale | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| Total Score | 81 ± 16 | 83 ± 12 |
| Strength | 15.9 ± 6.4 | 15.8 ± 10.3 |
Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.
| percentage of participants | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| Percentage of Participants Healed | 87 | 75 |
| Percentage of Participants Partially-Healed | 2 | 14 |
| Percentage of Participants Non-Healed | 10 | 11 |
Collected over Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Soft Tissue Trephination | 0/47 (0%) | 0/47 (0%) | 2/47 (4.3%) |
| Bone Trephination | 0/41 (0%) | 1/41 (2.4%) | 4/41 (9.8%) |
| Event | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| StrokeVascular disorders | 0/47 | 1/41 |
| Event | Soft Tissue Trephination | Bone Trephination |
|---|---|---|
| Revision SurgerySurgical and medical procedures | 2/47 | 2/41 |
| Radiating Pain into HandInvestigations | 0/47 | 1/41 |
| Olecranon FractureSurgical and medical procedures | 0/47 | 1/41 |
| Age, Continuous(years) | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Mean | 59.5 (40 to 73) | 58.8 (42 to 75) | 59.2 (40 to 75) |
| Sex: Female, Male(Participants) | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Female | 28 | 28 | 56 |
| Male | 19 | 13 | 32 |
| Race and Ethnicity Not Collected(Participants) | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Canada | 47 | 41 | 88 |
| Hand Dominance(Participants) | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Non-Dominant Arm Affected | 20 | 16 | 36 |
| Dominant Arm Affected | 27 | 25 | 52 |
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Ottawa Hospital Research Institute