Rotator Cuff Tear
Conditions
Keywords
rotator cuff tear
Brief summary
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.
Interventions
PROCEDUREBone Trephination
PROCEDURESoft Tissue Trephination
Sponsors
University of Ottawa
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff. * Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as: * The use of drugs including analgesics and non-steroidal anti-inflammatory drugs * Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc) * Activity modification * Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
Exclusion criteria
1. Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim. 2. Partial thickness cuff tears. 3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis 4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair. 5. Patients with active worker's compensation claims 6. Active joint or systemic infection 7. Significant muscle paralysis 8. Rotator cuff tear arthropathy 9. Charcot's arthropathy 10. Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica) 11. Major medical illness (life expectancy less then 1 year or unacceptably high operative risk) 12. Unable to speak or read English/French 13. Psychiatric illness that precludes informed consent 14. Unwilling to be followed for 1 year 15. Advanced physiologic age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index | From baseline to up until 24-Months Post-Operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores | From baseline to up until 24-Months Post-Operative | 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. |
| The Constant Score | From baseline to up until 24-Months Post-Operative | 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). |
| Healing Rates | From surgery to up until 24-Months Post-Operative | 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. |
Countries
Canada
Participant flow
Pre-assignment details
A number of participants who consented to be part of this study were withdrawn or excluded, prior to randomization due to study procedures not being able to be arranged pre-operatively for various reasons. A large number of participants were crossed over into another parallel study being run at The Ottawa Hospital.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Soft Tissue Trephination | 47 |
| Bone 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.
Bone Trephination | 41 |
| Total | 88 |
Baseline characteristics
| Characteristic | Soft Tissue Trephination | Bone Trephination | Total |
|---|---|---|---|
| Age, Continuous | 59.5 years | 58.8 years | 59.2 years |
| Hand Dominance Dominant Arm Affected | 27 Participants | 25 Participants | 52 Participants |
| Hand Dominance Non-Dominant Arm Affected | 20 Participants | 16 Participants | 36 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 47 participants | 41 participants | 88 participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 19 Participants | 13 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 41 |
| other Total, other adverse events | 2 / 47 | 4 / 41 |
| serious Total, serious adverse events | 0 / 47 | 1 / 41 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft Tissue Trephination | Western Ontario Rotator Cuff Index | 82 score on a scale | Standard Deviation 25 |
| Bone Trephination | Western Ontario Rotator Cuff Index | 80 score on a scale | Standard Deviation 21 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft Tissue Trephination | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores | 85 score on a scale | Standard Deviation 22 |
| Bone Trephination | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores | 84 score on a scale | Standard Deviation 17 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Soft Tissue Trephination | Healing Rates | Percentage of Participants Healed | 87 percentage of participants |
| Soft Tissue Trephination | Healing Rates | Percentage of Participants Partially-Healed | 2 percentage of participants |
| Soft Tissue Trephination | Healing Rates | Percentage of Participants Non-Healed | 10 percentage of participants |
| Bone Trephination | Healing Rates | Percentage of Participants Healed | 75 percentage of participants |
| Bone Trephination | Healing Rates | Percentage of Participants Partially-Healed | 14 percentage of participants |
| Bone Trephination | Healing Rates | Percentage of Participants Non-Healed | 11 percentage of participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soft Tissue Trephination | The Constant Score | Total Score | 81 score on a scale | Standard Deviation 16 |
| Soft Tissue Trephination | The Constant Score | Strength | 15.9 score on a scale | Standard Deviation 6.4 |
| Bone Trephination | The Constant Score | Total Score | 83 score on a scale | Standard Deviation 12 |
| Bone Trephination | The Constant Score | Strength | 15.8 score on a scale | Standard Deviation 10.3 |