Maximal Repair Versus Bridging Reconstruction With BioBrace®

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959733
• Other study ID #: BioBridge
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: January 2024
• Source: Nova Scotia Health Authority
• Contact: Sarah Remedios, MSc
• Phone: 9024737626
• Email: research[@]drivanwong.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	CONMED Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acromiohumeral Distance	Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.	2 year
Secondary	Muscle Atrophy	Using MRI, muscle atrophy will be measured using Warner's classification between groups.	2 year
Secondary	Fatty Infiltration	Fatty infiltration using the Goutallier classification will be used and identified	2 year
Secondary	Healing Rate	To measure the structural integrity of the surgery, Sugaya method will be used.	2 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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