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

NCT ID: NCT04710966

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-11-15

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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

debridement group

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.

Group Type: EXPERIMENTAL

arthroscopic debridement

Intervention Type: PROCEDURE

For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.

repair group

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.

Group Type: EXPERIMENTAL

arthroscopic repair

Intervention Type: PROCEDURE

For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.

Interventions

arthroscopic debridement

For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.

Intervention Type: PROCEDURE

arthroscopic repair

For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teng Wang

Role: PRINCIPAL_INVESTIGATOR

Investigator

Tengbo Yu

Role: STUDY_CHAIR

professor

Locations

Affiliated Hospital of Qingdao University

Qingdao, , China

Countries

China

References

Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.

Reference Type: RESULT

PMID: 2182260 (View on PubMed)

Chung SW, Kim JY, Yoon JP, Lyu SH, Rhee SM, Oh SB. Arthroscopic repair of partial-thickness and small full-thickness rotator cuff tears: tendon quality as a prognostic factor for repair integrity. Am J Sports Med. 2015 Mar;43(3):588-96. doi: 10.1177/0363546514561004. Epub 2014 Dec 22.

Reference Type: RESULT

PMID: 25535097 (View on PubMed)

Kwon OS, Kelly JI. Outcome analysis of arthroscopic treatment of partial thickness rotator cuff tears. Indian J Orthop. 2014 Jul;48(4):385-9. doi: 10.4103/0019-5413.136249.

Reference Type: RESULT

PMID: 25143642 (View on PubMed)

Strauss EJ, Salata MJ, Kercher J, Barker JU, McGill K, Bach BR Jr, Romeo AA, Verma NN. Multimedia article. The arthroscopic management of partial-thickness rotator cuff tears: a systematic review of the literature. Arthroscopy. 2011 Apr;27(4):568-80. doi: 10.1016/j.arthro.2010.09.019.

Reference Type: RESULT

PMID: 21296545 (View on PubMed)

Cordasco FA, Backer M, Craig EV, Klein D, Warren RF. The partial-thickness rotator cuff tear: is acromioplasty without repair sufficient? Am J Sports Med. 2002 Mar-Apr;30(2):257-60. doi: 10.1177/03635465020300021801.

Reference Type: RESULT

PMID: 11912097 (View on PubMed)

Wolff AB, Magit DP, Miller SR, Wyman J, Sethi PM. Arthroscopic fixation of bursal-sided rotator cuff tears. Arthroscopy. 2006 Nov;22(11):1247.e1-4. doi: 10.1016/j.arthro.2006.05.026.

Reference Type: RESULT

PMID: 17084305 (View on PubMed)

Zhang Y, Zhai S, Qi C, Chen J, Li H, Zhao X, Yu T. A comparative study of arthroscopic debridement versus repair for Ellman grade II bursal-side partial-thickness rotator cuff tears. J Shoulder Elbow Surg. 2020 Oct;29(10):2072-2079. doi: 10.1016/j.jse.2020.03.006. Epub 2020 Jun 1.

Reference Type: RESULT

PMID: 32499197 (View on PubMed)

Other Identifiers

wangteng

Identifier Type: -

Identifier Source: org_study_id