Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial (HDA v Regen)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristie More, MSc; Phone Number: 14032208954; Email: kristie.more@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HDA; Human dermal allograft (LifeNet Health Arthroflex graft)	Procedure: Rotator cuff repair; Arthroscopic rotator cuff repair augmented with graft.
Active Comparator: Regeneten; Bovine collagen patch xenograft (Smith & Nephew Regeneten)	Procedure: Rotator cuff repair; Arthroscopic rotator cuff repair augmented with graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Rotator Cuff Index (WORC)	rotator cuff quality of life outcome questionnaire	12 mos post-op

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REB23-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No