Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears
- Conditions
- Rotator Cuff Tears
- Interventions
- Procedure: arthroscopic repairProcedure: arthroscopic debridement
- Registration Number
- NCT04710966
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.
- Detailed Description
This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
- Failed of conservative treatment for more than 3 months
- Intraoperative arthroscopic confirmed that the tear was Ellman grade II
- Previous surgical surgery on the shoulder
- Articular-side or intratendinous rotator cuff tears
- Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
- Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
- The presence of other diseases that affect shoulder function
- Contraindication to arthroscopic surgery or anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description repair group arthroscopic repair For the repair group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic repair will be performed. debridement group arthroscopic debridement For the debridement group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic debridement will be performed.
- Primary Outcome Measures
Name Time Method The Visual Analog Scale score Postoperative 18 months Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Constant-Murray Shoulder score postoperative 18 months An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
American Shoulder and Elbow Surgeon score postoperative 18 months The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
University of California-Los Angeles score postoperative 18 months The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
- Secondary Outcome Measures
Name Time Method Grading of fatty degeneration 18 months after surgery Fatty degeneration in supraspinatus muscle was assessed by magnetic resonance imaging (MRI) according to a grading system with stages 0-4 as follows: grade 0, no fat; Grade 1, thin fatty streaks; Grade 2, heavy fat infiltration, with muscle still pre-dominating; Grade 3, even distribution of fat and muscle; Grade 4, more fat than muscle.
Grading of rotator cuff integrity 18 months after surgery The integrity of the rotator cuff was assessed by magnetic resonance imaging (MRI) according to a grading criteria, as follows: Grade I and II, sufficient thickness with low or partial high intensity; Grade III, insufficient thickness without discontinuity; Grade IV and V, presence of a minor or major discontinuity.
Grading of muscle atrophy 18 months after surgery Muscular atrophy was assessed on oblique sagittal MRI images using an occupation ratio measured by dividing the supraspinatus muscle's cross-sectional area by that of the supraspinatus fossa on the oblique-sagittal view. When the ratio was between 1.00 and 0.60, the muscle was considered normal or with slight atrophy (Grade I); values between 0.60 and 0.40 indicated moderate atrophy (Grade II); values below 0.40 indicated severe atrophy (Grade III).
Trial Locations
- Locations (1)
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China