Maximal Repair Versus Bridging Reconstruction With BioBrace®

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears; Bioinductive Implant
• Interventions: Procedure: Repair; Procedure: Bridging Reconstruction using BioBrace

• Registration Number: NCT05959733
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-25
• Study Start: 2023-12-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair	Repair	This group will undergo a rotator cuff repair procedure.
Bridging Reconstruction using BioBrace	Bridging Reconstruction using BioBrace	This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.

Primary Outcome Measures

Name	Time	Method
Radiographic or clinical failure	2 years	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

Secondary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index (WORC)	Baseline, 6-month, 1-year, 2-years	WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Muscle Atrophy	2 year	Using MRI, muscle atrophy will be measured using Warner's classification between groups.
Acromiohumeral Distance	2 year	Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.
Fatty Infiltration	2 year	Fatty infiltration using the Goutallier classification will be used and identified
Healing Rate	2 year	To measure the structural integrity of the surgery, Sugaya method will be used.
American Shoulder and Elbow Surgeon survey	Baseline, 6-month, 1-year, 2-years	American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
EQ-5D-5L	Baseline, 6-month, 1-year, 2-years	EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years
Range of motion	Baseline, 6-month, 1-year, 2-years	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
Shoulder strength	Baseline, 6-month, 1-year, 2-years	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
Biomechanics and Muscle Activity	Baseline and 2 years	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.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada