Maximal Repair Versus Bridging Reconstruction with BioBrace®

Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears; Bioinductive Implant
• Intervention / Treatment: Procedure: Repair; Procedure: Bridging Reconstruction using BioBrace

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Remedios, MSc; Phone Number: 9024737626; Email: research@drivanwong.com

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H2E1
      • Recruiting
      • Nova Scotia Health Authority
      • Contact: Ivan Wong; Phone Number: 9024737626; Email: research@drivanwong.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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
Active Comparator: Repair; This group will undergo a rotator cuff repair procedure.	Procedure: Repair; 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.
Experimental: Bridging Reconstruction using BioBrace; This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.	Procedure: Bridging Reconstruction using BioBrace; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acromiohumeral Distance	Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.	2 year
Muscle Atrophy	Using MRI, muscle atrophy will be measured using Warner's classification between groups.	2 year
Fatty Infiltration	Fatty infiltration using the Goutallier classification will be used and identified	2 year
Healing Rate	To measure the structural integrity of the surgery, Sugaya method will be used.	2 year
Western Ontario Rotator Cuff Index (WORC)	WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years	Baseline, 6-month, 1-year, 2-years
American Shoulder and Elbow Surgeon survey	American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years	Baseline, 6-month, 1-year, 2-years
EQ-5D-5L	EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years	Baseline, 6-month, 1-year, 2-years
Range of motion	The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years	Baseline, 6-month, 1-year, 2-years
Shoulder strength	The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years	Baseline, 6-month, 1-year, 2-years
Biomechanics and Muscle Activity	Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment.	Baseline and 2 years

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: CONMED Corporation
• Investigators: Principal Investigator: Ivan Wong, MD, Nova Scotia Health Authority, Orthopaedic Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: biomechanics; shoulder; clinical outcomes; radiographic outcomes; rotator cuff; rotator cuff repair; bridging reconstruction
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: BioBridge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes