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

NCT04710966 | Completed

• 1 other identifier: wangteng
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

partial-thickness; bursal-side tear; rotator cuff tears; arthroscopic debridement; arthroscopic repair

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (3)

• Grading of rotator cuff integrity

  18 months after surgery

• Grading of muscle atrophy

  18 months after surgery

• Grading of fatty degeneration

  18 months after surgery

Study Arms (2)

debridement group

EXPERIMENTAL

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

repair group

EXPERIMENTAL

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

Interventions

arthroscopic debridement PROCEDURE

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

debridement group

arthroscopic repair PROCEDURE

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

repair group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, 266000, China

Location

Related Publications (7)

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

  PMID: 2182260 RESULT

• 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.

  PMID: 25535097 RESULT

• 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.

  PMID: 25143642 RESULT

• 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.

  PMID: 21296545 RESULT

• 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.

  PMID: 11912097 RESULT

• 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.

  PMID: 17084305 RESULT

• 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.

  PMID: 32499197 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Teng Wang

  Investigator

  PRINCIPAL INVESTIGATOR

• Tengbo Yu

  professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 15, 2021
• Study Start: September 1, 2017
• Primary Completion: October 31, 2020
• Study Completion: November 15, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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 .

Locations

CN (1)