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

A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04587037
Enrollment
25
Registered
2020-10-14
Start date
2020-10-31
Completion date
2023-10-31
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction, Fascia lata allograft, human dermal allograft

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.

Interventions

PROCEDUREfascia lata allograft

underwent superior capsule reconstruction using fascia lata allograft

PROCEDUREhuman dermal allograft

underwent superior capsule reconstruction using human dermal allograft

Sponsors

Beijing Jishuitan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
American Shoulder and Elbow Surgeons (ASES) score2 year postoperativelyA patient-reported outcome measurement
Acromiohumeral distance (AHD)1 year postoperativelymeasured in X-ray
Retear rate1 year postoperativelyMeasured in MRI

Contacts

Primary ContactZhijun Zhang, M.D.
zzj5285029@163.com+86 15201277648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026