Clinical Study on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation

Completed

• Conditions: Subscapularis Tendon Rupture

• Registration Number: NCT02383914
• Lead Sponsor: University of Rostock

Brief Summary

The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as the circumstances require to found a new classification.

The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic and magnetic resonance tomography findings.

The secondary objective is to detect the correlation of the outcome with the age , the gender, the pathogenesis and attendant injuries.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2015-03-08
• Study First Posted: 2015-03-10
• Primary Completion: 2017-12
• Study Completion: 2018-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• patients, who have turned 18
• suspected subscapularis tendon rupture

Exclusion Criteria

• disability to understand the trial
• intraoperative intact supbscapularis tendon
• pre-surgical operation of the affected shoulder
• tumor
• infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder function (Constant Score)	52 weeks post- operative

Secondary Outcome Measures

Name	Time	Method
Strength	12 and 52 weeks post-operative	Strength will be measured by a special force sensor
Rerupture Rate	12 and 52 weeks post-operative	Sonographic investigation of rerupture rate

Trial Locations

Locations (1)

Orthopaedic Clinic of the University of Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany