Rotator Cuff Tears
Conditions
Keywords
partial-thickness, bursal-side tear, rotator cuff tears, arthroscopic debridement, arthroscopic repair
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.
Interventions
PROCEDUREarthroscopic debridement
For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.
PROCEDUREarthroscopic repair
For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
Intervention model description
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. According to preoperative allocation, the patients were given arthroscopic debridement or repair respectively.For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, we converted partial tears into full-thickness tears and sutured them
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Visual Analog Scale score | Baseline | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). |
| Constant-Murray Shoulder score | Baseline | 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 | Baseline | 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 | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
China
Outcome results
None listed