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

NCT ID: NCT04587037

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fascia lata group

Group Type EXPERIMENTAL

fascia lata allograft

Intervention Type PROCEDURE

underwent superior capsule reconstruction using fascia lata allograft

Dermal allograft group

Group Type EXPERIMENTAL

human dermal allograft

Intervention Type PROCEDURE

underwent superior capsule reconstruction using human dermal allograft

Interventions

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fascia lata allograft

underwent superior capsule reconstruction using fascia lata allograft

Intervention Type PROCEDURE

human dermal allograft

underwent superior capsule reconstruction using human dermal allograft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunyan Jiang

Role: PRINCIPAL_INVESTIGATOR

Sports Medicine Service, Beijing Jishuitan hospital

Central Contacts

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Zhijun Zhang, M.D.

Role: CONTACT

+86 15201277648

Other Identifiers

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CJiang-SCR Compare

Identifier Type: -

Identifier Source: org_study_id

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