Clinical trial NCT04710966: Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears
Official title: Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: partial-thickness
bursal-side tear
rotator cuff tears
arthroscopic debridement
arthroscopic repair
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Visual Analog Scale score
timeFrame: Baseline
measure: The Visual Analog Scale score
timeFrame: Postoperative 6 months
measure: The Visual Analog Scale score
timeFrame: Postoperative 12 months
measure: The Visual Analog Scale score
timeFrame: Postoperative 18 months
measure: Constant-Murray Shoulder score
timeFrame: Baseline
measure: Constant-Murray Shoulder score
timeFrame: postoperative 6 months
measure: Constant-Murray Shoulder score
timeFrame: postoperative 12 months
measure: Constant-Murray Shoulder score
timeFrame: postoperative 18 months
measure: American Shoulder and Elbow Surgeon score
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeon score
timeFrame: postoperative 6 months
measure: American Shoulder and Elbow Surgeon score
timeFrame: postoperative 12 months
measure: American Shoulder and Elbow Surgeon score
timeFrame: postoperative 18 months
measure: University of California-Los Angeles score
timeFrame: Baseline
measure: University of California-Los Angeles score
timeFrame: postoperative 6 months
measure: University of California-Los Angeles score
timeFrame: postoperative 12 months
measure: University of California-Los Angeles score
timeFrame: postoperative 18 months
Secondary outcomes:
measure: Grading of rotator cuff integrity
timeFrame: 18 months after surgery
measure: Grading of muscle atrophy
timeFrame: 18 months after surgery
measure: Grading of fatty degeneration
timeFrame: 18 months after surgery
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
Study officials:
affiliation: Investigator
name: Teng Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: professor
name: Tengbo Yu
role: STUDY_CHAIR
References:
citation: Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.