A Clinical Study Comparing Superior Capsule Reconstructio... | NCT04587037

Studies
A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear

NCT04587037

Sponsor

Beijing Jishuitan Hospital

Status

Unknown status

Last Update Posted

Oct 14, 2020Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Rotator Cuff Tears

Interventions

fascia lata allograft
human dermal allograft

Countries

Not provided

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2020Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Oct 7, 2020

First Submission Date that Met QC Criteria

Oct 7, 2020

First Posted Date

Oct 14, 2020Actual

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

Oct 7, 2020

Last Update Posted Date

Oct 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chunyan Jiang, Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan HospitalPrincipal Investigator

Lead Sponsor

Beijing Jishuitan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fascia lata group	Experimental		Procedure: fascia lata allograft
Dermal allograft group	Experimental		Procedure: human dermal allograft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fascia lata allograft	Procedure	underwent superior capsule reconstruction using fascia lata allograft	Fascia lata group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) score	A patient-reported outcome measurement	2 year postoperatively
Acromiohumeral distance (AHD)	measured in X-ray	1 year postoperatively
Retear rate	Measured in MRI	1 year postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with irreparable rotator cuff tears
Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
At least two years follow-up

Exclusion Criteria:

reparable rotator cuff tears
underwent partial repair or reverse total shoulder arthroplasty

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhijun Zhang, M.D.	Contact	+86 15201277648		zzj5285029@163.com

Overall Officials

Name	Affiliation	Role
Chunyan Jiang	Sports Medicine Service, Beijing Jishuitan hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

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Browse Branches

Not provided