Rotator Cuff TearsNCT04587037
A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
A study testing fascia lata allograft and human dermal allograft in people with Rotator Cuff Tears, run by Beijing Jishuitan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- fascia lata allograft and human dermal allograft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with irreparable rotator cuff tears
- Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
- At least two years follow-up
Who cannot join
- reparable rotator cuff tears
- underwent partial repair or reverse total shoulder arthroplasty
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
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.
- Conditions
- Rotator Cuff Tears
- Being tested
- fascia lata allograft, human dermal allograft
- Keywords
- Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction, Fascia lata allograft, human dermal allograft
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia lata allograftProcedure or surgery
underwent superior capsule reconstruction using fascia lata allograft
human dermal allograftProcedure or surgery
underwent superior capsule reconstruction using human dermal allograft
| Study group | Role | What they receive |
|---|---|---|
| Fascia lata group | Experimental | Not described Receives: Procedure: fascia lata allograft |
| Dermal allograft group | Experimental | Not described Receives: Procedure: human dermal allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) score
A patient-reported outcome measurement
Measured: 2 year postoperatively
Acromiohumeral distance (AHD)
measured in X-ray
Measured: 1 year postoperatively
Retear rate
Measured in MRI
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Jiang, Beijing Jishuitan Hospital
- Investigators
- Chunyan Jiang, Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587037
- Sponsor's protocol ID
- CJiang-SCR Compare
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT04587037
- Acronym / sponsor ID
- CJiang-SCR Compare
- Conditions
- Rotator Cuff Tears
- Keywords
- Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction, Fascia lata allograft, human dermal allograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia lata group | Experimental | Procedure: fascia lata allograft |
| Dermal allograft group | Experimental | Procedure: human dermal allograft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with irreparable rotator cuff tears
- Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
- At least two years follow-up
Key exclusion criteria (2 listed)
- reparable rotator cuff tears
- underwent partial repair or reverse total shoulder arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fascia lata allograftunderwent superior capsule reconstruction using fascia lata allograft | Procedure or surgery | Fascia lata group |
| human dermal allograftunderwent superior capsule reconstruction using human dermal allograft | Procedure or surgery | Dermal allograft group |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) score
Time frame: 2 year postoperatively
A patient-reported outcome measurement
Acromiohumeral distance (AHD)
Time frame: 1 year postoperatively
measured in X-ray
Retear rate
Time frame: 1 year postoperatively
Measured in MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Jiang principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
Questions about this trial
What is this clinical trial studying?
A study testing fascia lata allograft and human dermal allograft in people with Rotator Cuff Tears, run by Beijing Jishuitan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Zhang, M.D. (+86 15201277648, zzj5285029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) score (time frame: 2 year postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.