Clinical Study on Diagnostics and Outcome of Ruptures of... | NCT02383914

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

NCT02383914

Sponsor

University of Rostock

Status

Completed

Last Update Posted

Nov 6, 2020Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Subscapularis Tendon Rupture

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Oct 2018Actual

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

Mar 8, 2015

First Posted Date

Mar 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. med. Thomas Tischer, Prof. Dr. med. Thomas Tischer, University of RostockPrincipal Investigator

Lead Sponsor

University of RostockOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Subscapularis rupture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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 .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic Clinic of the University of Rostock		Rostock	Mecklenburg-Vorpommern	18057	Germany