Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?

NCT02628457 | Unknown DMC

• 1 other identifier: CMH-2015-02
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction

Conditions

Rotator Cuff Tear

Keywords

occupation ratio; pseudoatrophy

Outcome Measures

Primary Outcomes (1)

• change in supraspinatus muscle atrophy

  Supraspinatus muscle atrophy was measured and evaluated according to the Thomazeau classification. Stage 1: slight atrophy occupation ratio (1.00-0.60), Stage 2: moderate atrophy occupation ratio (0.60-0.40), Stage 3: Severe atrophy occupation ratio(\<0.40). Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient.Postoperative occupation ratio was compared with preoperative occupation ratio within the groups and change in occupation ratio was used for comparison between the groups.

  within 1 week after surgery

Study Arms (3)

Mild Subgroup

patients with supraspinatus tendon retracted upto medial 1/3rd of humerus head and arthroscopic rotator cuff repair done by single row.

Procedure: arthroscopic rotator cuff repair

Moderate Subgroup

patients with supraspinatus tendon retracted between medial 1/3rd of humerus head and glenoid,and arthroscopic rotator cuff repair done by single row.

Procedure: arthroscopic rotator cuff repair

Severe subgroup

patients with supraspinatus tendon retracted beyond glenoid and arthroscopic rotator cuff repair done by single row

Procedure: arthroscopic rotator cuff repair

Interventions

arthroscopic rotator cuff repair PROCEDURE

arthroscopic rotator cuff repair done in all patients to check whether, surgery itself changes the appearance of muscle atrophy in the supraspinatus in all patients irrespective of size of preoperative tendon retraction

Mild Subgroup; Moderate Subgroup; Severe subgroup

Eligibility Criteria

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

Study Population

209 patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair between March 2012 and April 2015 in CM hospital

You may qualify if:

• Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.
• Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.
• Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.

You may not qualify if:

• Patients with preoperative MRI from outside hospital.
• Patients with isolated subscapularis tear.
• Patients with previous operation on the same shoulder joint.
• Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.

Sponsors & Collaborators

• CM Chungmu Hospital: lead

Study Sites (1)

Chungmu General Hopsital

Yeongdeungpo-gu, Seoul, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• sang-Hoon Lhee, MD PhD

  President, CM general Hospital

  STUDY CHAIR

• Anant kumar Singh

  arthroscopy fellow, CM general Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 11, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)