Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears

Qingdao University

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Procedure: arthroscopic debridement; Procedure: arthroscopic repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04710966

wangteng

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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179 participants in 2 patient groups

debridement group

Experimental group

Description:

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.

Treatment:

Procedure: arthroscopic debridement

repair group

Experimental group

Description:

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.

Treatment:

Procedure: arthroscopic repair