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

November 4, 2020 updated by: PD Dr. med. Thomas Tischer, University of Rostock

Prospective Multicenter Trial on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Orthopaedic Clinic of the University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of the patients, who got the operative therapy (refixaton of the subscapularis tendon) inclusive the post- treatment and satisfy the criteria .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subscapularis rupture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shoulder function (Constant Score)
Time Frame: 52 weeks post- operative
52 weeks post- operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: 12 and 52 weeks post-operative
Strength will be measured by a special force sensor
12 and 52 weeks post-operative
Rerupture Rate
Time Frame: 12 and 52 weeks post-operative
Sonographic investigation of rerupture rate
12 and 52 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

March 8, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Subscap-042014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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