Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial

Rotator Cuff Tears Clinical Trial

— HDA v Regen  

Official title:

Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215417
• Other study ID #: REB23-0276
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2024
• Est. completion date: December 2029

Study information

• Verified date: January 2024
• Source: University of Calgary
• Contact: Kristie More, MSc
• Phone: 14032208954
• Email: kristie.more[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

>18 years

• fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff Index (WORC)	rotator cuff quality of life outcome questionnaire	12 mos post-op
Secondary	Western Ontario Rotator Cuff Index (WORC)	rotator cuff quality of life outcome questionnaire	pre-op, 3 mos, 6 mos, 24 mos post-op
Secondary	Single Assessment Numeric Evaluation (SANE)	numeric score indicating shoulder assessment	pre-op, 3mos, 6mos, 12mos, 24mos post-op
Secondary	EuroQOL5D	general health assessment score	pre-op, 3mos, 6mos, 12mos, 24mos post-op
Secondary	Shoulder pain assessed by visual analog scale (VAS)	assessment of shoulder pain	pre-op, 3mos, 6mos, 12mos, 24mos post-op
Secondary	Anatomic healing	anatomic healing as assessed via MRI	12mos post-op