Maximal Repair Versus Bridging Reconstruction With BioBrace®

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Bridging Reconstruction using BioBrace

Repair

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring shoulder, rotator cuff, clinical outcomes, radiographic outcomes, biomechanics, bridging reconstruction, rotator cuff repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Repair

Bridging Reconstruction using BioBrace

Arm Description

This group will undergo a rotator cuff repair procedure.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acromiohumeral Distance

Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.

Muscle Atrophy

Using MRI, muscle atrophy will be measured using Warner's classification between groups.

Fatty Infiltration

Fatty infiltration using the Goutallier classification will be used and identified

Healing Rate

To measure the structural integrity of the surgery, Sugaya method will be used.

Western Ontario Rotator Cuff Index (WORC)

WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 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

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

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

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

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.

Full Information

NCT ID

NCT05959733

First Posted

July 5, 2023

Last Updated

August 22, 2023

Sponsor

Nova Scotia Health Authority

Collaborators

CONMED Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05959733

Brief Title

Maximal Repair Versus Bridging Reconstruction With BioBrace®

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

July 31, 2027 (Anticipated)

Study Completion Date

July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Scotia Health Authority

Collaborators

CONMED Corporation

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears, Bioinductive Implant

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Repair

Arm Type

Active Comparator

Arm Description

This group will undergo a rotator cuff repair procedure.

Arm Title

Bridging Reconstruction using BioBrace

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Bridging Reconstruction using BioBrace

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Repair

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiographic or clinical failure

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Acromiohumeral Distance

Description

Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.

Time Frame

2 year

Title

Muscle Atrophy

Description

Using MRI, muscle atrophy will be measured using Warner's classification between groups.

Time Frame

2 year

Title

Fatty Infiltration

Description

Fatty infiltration using the Goutallier classification will be used and identified

Time Frame

2 year

Title

Healing Rate

Description

To measure the structural integrity of the surgery, Sugaya method will be used.

Time Frame

2 year

Title

Western Ontario Rotator Cuff Index (WORC)

Description

WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years

Time Frame