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

Subscapularis Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383914
• Other study ID #: Subscap-042014
• Status: Completed
• Start date: March 2014
• Est. completion date: October 2018

Study information

• Verified date: November 2020
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rupture
• Subscapularis Tendon Rupture

Locations

Country	Name	City	State
Germany	Orthopaedic Clinic of the University of Rostock	Rostock	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function (Constant Score)		52 weeks post- operative
Secondary	Strength	Strength will be measured by a special force sensor	12 and 52 weeks post-operative
Secondary	Rerupture Rate	Sonographic investigation of rerupture rate	12 and 52 weeks post-operative