Rotator Cuff Tear, Shoulder Impingement Syndrome
Conditions
Keywords
Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery
Brief summary
Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.
Detailed description
There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone. The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff. We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.
Interventions
PROCEDUREAcromioplasty
Sponsors
Panam Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 or older * Complete rotator cuff tear up to 4 cm in size * Persistent pain and functional disability for at least 6 months * Failure of conservative treatment * Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability
Exclusion criteria
* Evidence of significant osteoarthritis or cartilage damage in the shoulder * Evidence of glenohumeral instability including Bankart lesions and labral tears of any type * Previous surgeries of the shoulder * Evidence of major joint trauma, infection, or necrosis in the shoulder * Patients with partial thickness tears of the rotator cuff * Patients unable to provide informed consent due to language barrier or mental status * Patients with a major medical condition that would affect quality of life and influence the results of the study * Patients with worker compensation claims * Patients unwilling to be followed for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | 24 months | Calculated as percentage with an increase in score indicating an improvement in outcome. |
| American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | 24 months | Calculated as a percentage with an increase in score reflecting an improvement in outcome. |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Range of Motion | 24 months |
| Upper Extremity Strength Grading | 24 months |
Countries
Canada
Participant flow
Recruitment details
A total of 86 patients were randomized to either ACR-A or ACR
Participants by arm
| Arm | Count |
|---|---|
| Arthroscopic Rotator Cuff Repair Without Acromioplasty Arthroscopic rotator cuff repair without acromioplasty (ACR) | 41 |
| Arthroscopic Rotator Cuff Repair With Acromioplasty Arthroscopic rotator cuff repair with acromioplasty (ACR-A) | 45 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 1 |
Baseline characteristics
| Characteristic | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 45 Participants | 86 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 9.5 | 56.2 years STANDARD_DEVIATION 7.9 | 56.7 years STANDARD_DEVIATION 8.7 |
| Gender Female | 15 participants | 14 participants | 29 participants |
| Gender Male | 30 participants | 24 participants | 54 participants |
| Region of Enrollment Canada | 41 participants | 45 participants | 86 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 45 |
| serious Total, serious adverse events | 0 / 41 | 0 / 45 |
Outcome results
Primary
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arthroscopic Rotator Cuff Repair Without Acromioplasty | American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | 84.6 percentage of total score | Standard Deviation 20.1 |
| Arthroscopic Rotator Cuff Repair With Acromioplasty | American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | 89.8 percentage of total score | Standard Deviation 14.4 |
Primary
Western Ontario Rotator Cuff Index (WORC)
Calculated as percentage with an increase in score indicating an improvement in outcome.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arthroscopic Rotator Cuff Repair Without Acromioplasty | Western Ontario Rotator Cuff Index (WORC) | 80.5 percentage of total score | Standard Deviation 22.3 |
| Arthroscopic Rotator Cuff Repair With Acromioplasty | Western Ontario Rotator Cuff Index (WORC) | 86.7 percentage of total score | Standard Deviation 16.2 |
Secondary
Shoulder Range of Motion
Time frame: 24 months
Secondary
Upper Extremity Strength Grading
Time frame: 24 months