NCT04587037

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 7, 2020

Last Update Submit

October 7, 2020

Conditions

Rotator Cuff Tears

Keywords

Irreparable Rotator Cuff TearsSuperior Capsular ReconstructionFascia lata allografthuman dermal allograft

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Fascia lata group

EXPERIMENTAL
Procedure: fascia lata allograft

Dermal allograft group

EXPERIMENTAL
Procedure: human dermal allograft

Interventions

fascia lata allograftPROCEDURE

underwent superior capsule reconstruction using fascia lata allograft

Fascia lata group
human dermal allograftPROCEDURE

underwent superior capsule reconstruction using human dermal allograft

Dermal allograft group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Chunyan Jiang

    Sports Medicine Service, Beijing Jishuitan hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Zhang, M.D.

CONTACT

+86 15201277648zzj5285029@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share