Maximal Repair Versus Bridging Reconstruction with BioBrace®

NCT05959733 | Recruiting FDA Device

• 1 other identifier: BioBridge
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.

Conditions

Rotator Cuff Tears; Bioinductive Implant

Keywords

shoulder; rotator cuff; clinical outcomes; radiographic outcomes; biomechanics; bridging reconstruction; rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• Radiographic or clinical failure

  The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up

  2 years

Secondary Outcomes (10)

• Acromiohumeral Distance

  2 year

• Muscle Atrophy

  2 year

• Fatty Infiltration

  2 year

• Healing Rate

  2 year

• Western Ontario Rotator Cuff Index (WORC)

  Baseline, 6-month, 1-year, 2-years

Study Arms (2)

Repair

ACTIVE COMPARATOR

This group will undergo a rotator cuff repair procedure.

Procedure: Repair

Bridging Reconstruction using BioBrace

EXPERIMENTAL

This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.

Procedure: Bridging Reconstruction using BioBrace

Interventions

Bridging Reconstruction using BioBrace PROCEDURE

Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.

Bridging Reconstruction using BioBrace

Repair PROCEDURE

Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.

Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
• over 18 years of age

You may not qualify if:

• glenohumeral osteoarthritis
• Western Ontario rotator cuff score \>60
• uncontrolled diabetes (Hgb A1C \>7%)
• pregnant
• local or systemic infection
• inability to cooperate with and/or comprehend post-operative instructions
• MRI proven non-vascular sites
• poor nutritional state (Alb \<30 g/L)
• cancer
• paralysis of the shoulder
• contracture of the shoulder
• patients unable to provide informed consent for the study

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• CONMED Corporation: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E1, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Ivan Wong, MD

  Nova Scotia Health Authority, Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Remedios, MSc

CONTACT

9024737626; research@drivanwong.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware to the type of surgery that they received. The investigator will not be blinded, however, the individuals assessing the outcomes will be.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Orthopaedic Surgeon

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 25, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)