Rotator Cuff TearsPhase 4HDA v RegenNCT06215417
Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
A Phase 4 study testing Rotator cuff repair in people with Rotator Cuff Tears, run by University of Calgary.
Trial summary
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
Who cannot join
- tears where only a partial repair is achieved
- significant glenohumeral joint arthropathy (Hamada grade 2 and above)
- irreparable rotator cuff tears
- patients unable or unwilling to consent or comply with study questionnaires
- patients with upper limb neurological deficits affecting the ipsilateral limb
- workers compensation cases
- cases involving litigation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Read the detailed description
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Subjects will be randomized intraoperatively after confirmation of inclusion criteria.
Subjects will be followed-up at 3 weeks, 3 months, 6 months, 12 months and 24 months post-operatively.
Primary outcome is Western Ontario Rotator Cuff Index (WORC) at 12 months. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Single Numeric Evaluation (SANE) score, EuroQoL (5 domains) score (a quality of life score), and Visual Analogue Scale, healing rate as determined by Magnetic Resonance Imaging (MRI) scan at 12 months post surgery. To determine the cost utility, data will be collected on the cumulative cost for the total episode of care up to 12 months post surgery inclusive of surgical costs, implant costs, outpatient costs, and medication costs. Quality-Adjusted Life Years (QALYs) gained will be calculated using the mean total cost and the quality of life score (EQ-5D) improvement from pre-operative to 12 months post surgery.
- Conditions
- Rotator Cuff Tears
- Being tested
- Rotator cuff repair
- 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.
Rotator cuff repairProcedure or surgery
Arthroscopic rotator cuff repair augmented with graft.
| Study group | Role | What they receive |
|---|---|---|
| HDA | Experimental | Human dermal allograft (LifeNet Health Arthroflex graft) Receives: Procedure: Rotator cuff repair |
| Regeneten | Active comparator | Bovine collagen patch xenograft (Smith \& Nephew Regeneten) Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index (WORC)
rotator cuff quality of life outcome questionnaire
Measured: 12 mos post-op
Secondary outcomes (5)
Western Ontario Rotator Cuff Index (WORC)
rotator cuff quality of life outcome questionnaire
Measured: pre-op, 3 mos, 6 mos, 24 mos post-op
Single Assessment Numeric Evaluation (SANE)
numeric score indicating shoulder assessment
Measured: pre-op, 3mos, 6mos, 12mos, 24mos post-op
EuroQOL5D
general health assessment score
Measured: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Shoulder pain assessed by visual analog scale (VAS)
assessment of shoulder pain
Measured: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Anatomic healing
anatomic healing as assessed via MRI
Measured: 12mos post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a parallel group 1:1 randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215417
- Sponsor's protocol ID
- REB23-0276
- Acronym
- HDA v Regen
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06215417
- Acronym / sponsor ID
- HDA v Regen / REB23-0276
- Conditions
- Rotator Cuff Tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jan 2024 (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.
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Detailed description
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Subjects will be randomized intraoperatively after confirmation of inclusion criteria.
Subjects will be followed-up at 3 weeks, 3 months, 6 months, 12 months and 24 months post-operatively.
Primary outcome is Western Ontario Rotator Cuff Index (WORC) at 12 months. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Single Numeric Evaluation (SANE) score, EuroQoL (5 domains) score (a quality of life score), and Visual Analogue Scale, healing rate as determined by Magnetic Resonance Imaging (MRI) scan at 12 months post surgery. To determine the cost utility, data will be collected on the cumulative cost for the total episode of care up to 12 months post surgery inclusive of surgical costs, implant costs, outpatient costs, and medication costs. Quality-Adjusted Life Years (QALYs) gained will be calculated using the mean total cost and the quality of life score (EQ-5D) improvement from pre-operative to 12 months post surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a parallel group 1:1 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HDA | Experimental | Procedure: Rotator cuff repairHuman dermal allograft (LifeNet Health Arthroflex graft) |
| Regeneten | Active comparator | Procedure: Rotator cuff repairBovine collagen patch xenograft (Smith \& Nephew Regeneten) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
Key exclusion criteria (7 listed)
- tears where only a partial repair is achieved
- significant glenohumeral joint arthropathy (Hamada grade 2 and above)
- irreparable rotator cuff tears
- patients unable or unwilling to consent or comply with study questionnaires
- patients with upper limb neurological deficits affecting the ipsilateral limb
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 |
|---|---|---|
| Rotator cuff repairArthroscopic rotator cuff repair augmented with graft. | Procedure or surgery | HDA, Regeneten |
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: 12 mos post-op
rotator cuff quality of life outcome questionnaire
5 secondary outcomes
Western Ontario Rotator Cuff Index (WORC)
Time frame: pre-op, 3 mos, 6 mos, 24 mos post-op
Single Assessment Numeric Evaluation (SANE)
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
EuroQOL5D
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Shoulder pain assessed by visual analog scale (VAS)
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Anatomic healing
Time frame: 12mos post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No. No sharing of IPD.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotator cuff repair in people with Rotator Cuff Tears, run by University of Calgary.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Jan 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristie More, MSc (14032208954, kristie.more@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (WORC) (time frame: 12 mos post-op). 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 22 Jan 2024.