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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02628457
• Other study ID #: CMH-2015-02
• Status: Active, not recruiting
• Phase: N/A
• First received: December 3, 2015
• Last updated: December 10, 2015
• Start date: December 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: CM Chungmu Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Description:

Retrospective review of 209 patients having both preoperative and immediate postoperative MRI done. Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. Patient were divided in two major group according to age that is <60 years and >60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of MRI. Postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. Change in occupation ratio was also used for comparison between 2 major groups

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 209
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.

2. Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.

3. Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.

Exclusion Criteria:

1. Patients with preoperative MRI from outside hospital.

2. Patients with isolated subscapularis tear.

3. Patients with previous operation on the same shoulder joint.

4. Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Muscular Atrophy
• Rotator Cuff Tear

Intervention

Procedure:
• arthroscopic rotator cuff repair
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

Locations

Country	Name	City	State
Korea, Republic of	Chungmu General Hopsital	Yeongdeungpo-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CM Chungmu Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes