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

NCT06215417 | Not Yet Recruiting Phase 4

• 1 other identifier: REB23-0276
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Index (WORC)

  rotator cuff quality of life outcome questionnaire

  12 mos post-op

Secondary Outcomes (5)

• Western Ontario Rotator Cuff Index (WORC)

  pre-op, 3 mos, 6 mos, 24 mos post-op

• Single Assessment Numeric Evaluation (SANE)

  pre-op, 3mos, 6mos, 12mos, 24mos post-op

• EuroQOL5D

  pre-op, 3mos, 6mos, 12mos, 24mos post-op

• Shoulder pain assessed by visual analog scale (VAS)

  pre-op, 3mos, 6mos, 12mos, 24mos post-op

• Anatomic healing

  12mos post-op

Study Arms (2)

HDA

EXPERIMENTAL

Human dermal allograft (LifeNet Health Arthroflex graft)

Procedure: Rotator cuff repair

Regeneten

ACTIVE COMPARATOR

Bovine collagen patch xenograft (Smith \& Nephew Regeneten)

Procedure: Rotator cuff repair

Interventions

Rotator cuff repair PROCEDURE

Arthroscopic rotator cuff repair augmented with graft.

HDA; Regeneten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• \- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Kristie More, MSc

CONTACT

14032208954; kristie.more@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and research assistants collecting data will be unaware of the treatment assigned until the completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a parallel group 1:1 randomized controlled trial

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share