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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02383914

Enrollment

Registered

2015-03-10

Start date

2014-03-31

Completion date

2018-10-31

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subscapularis Tendon Rupture

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Shoulder function (Constant Score)	52 weeks post- operative

Secondary

Measure	Time frame	Description
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

Countries

Germany

Outcome results