NCT02383914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

May 6, 2014

Last Update Submit

November 4, 2020

Conditions

Subscapularis Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • Shoulder function (Constant Score)

    52 weeks post- operative

Secondary Outcomes (2)

  • Strength

    12 and 52 weeks post-operative

  • Rerupture Rate

    12 and 52 weeks post-operative

Study Arms (1)

Subscapularis rupture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Clinic of the University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Thomas Tischer

Study Record Dates

First Submitted

May 6, 2014

First Posted

March 10, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2017

Study Completion

October 1, 2018

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

DE(1)