Repair of Subscapularis Tear :Clinical Results and MRI An... | NCT01752088

Studies
Repair of Subscapularis Tear :Clinical Results and MRI Analysis

NCT01752088

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Nov 9, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Rupture Subscapularis Tendon

Interventions

Not provided

Countries

China

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 2022

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

Jun 1, 2012Actual

Primary Completion Date

Jun 1, 2013Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Dec 14, 2012

First Submission Date that Met QC Criteria

Dec 18, 2012

First Posted Date

Dec 19, 2012Estimated

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 8, 2022

Last Update Posted Date

Nov 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of arthroscopic repair of subscapularis tears

Detailed Description

ROM UCLA Constant ASES VAS MRI Goutallier

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical results and MRI analysis	ROM UCLA Constant ASES VAS MRI	2 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients suffering from rotator cuff injury scheduled for an arthroscopic procedure. A partial- or full-thickness subscapu-laris tendon tear

Exclusion Criteria:

- revision repairs or open repairs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suffering from rotator cuff injury will be scheduled for an arthroscopic procedure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guoqing Cui, MD	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100191	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22632896	Background	Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.