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

Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: arthroscopic debridement; Procedure: arthroscopic 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.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qingdao, China, 266000
    • Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: arthroscopic debridement; For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.
EXPERIMENTAL: 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.	Procedure: arthroscopic repair; For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Baseline
The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 6 months
The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 12 months
The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 18 months
Constant-Murray Shoulder score	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.	Baseline
Constant-Murray Shoulder score	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.	postoperative 6 months
Constant-Murray Shoulder score	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.	postoperative 12 months
Constant-Murray Shoulder score	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.	postoperative 18 months
American Shoulder and Elbow Surgeon score	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.	Baseline
American Shoulder and Elbow Surgeon score	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.	postoperative 6 months
American Shoulder and Elbow Surgeon score	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.	postoperative 12 months
American Shoulder and Elbow Surgeon score	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.	postoperative 18 months
University of California-Los Angeles score	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.	Baseline
University of California-Los Angeles score	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.	postoperative 6 months
University of California-Los Angeles score	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.	postoperative 12 months
University of California-Los Angeles score	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.	postoperative 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grading of rotator cuff integrity	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.	18 months after surgery
Grading of muscle atrophy	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).	18 months after surgery
Grading of fatty degeneration	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.	18 months after surgery

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Teng Wang, Investigator; Study Chair: Tengbo Yu, PROFESSOR

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): October 31, 2020
• Study Completion (ACTUAL): November 15, 2020

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: arthroscopic repair; rotator cuff tears; partial-thickness; bursal-side tear; arthroscopic debridement
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: wangteng

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to wt10113277@163.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website .
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No