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Recruiting NCT05959733

Maximal Repair Versus Bridging Reconstruction with BioBrace®

No phase Interventional Rotator Cuff Tears Bioinductive Implant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bridging Reconstruction using BioBrace, Repair.
Who it may be relevant to
Registry conditions: Rotator Cuff Tears, Bioinductive Implant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Radiographic or clinical failure [Time frame: 2 years]
Secondary outcome measures (10)
  • Acromiohumeral Distance [Time frame: 2 year]
  • Muscle Atrophy [Time frame: 2 year]
  • Fatty Infiltration [Time frame: 2 year]
  • Healing Rate [Time frame: 2 year]
  • Western Ontario Rotator Cuff Index (WORC) [Time frame: Baseline, 6-month, 1-year, 2-years]
  • American Shoulder and Elbow Surgeon survey [Time frame: Baseline, 6-month, 1-year, 2-years]
  • EQ-5D-5L [Time frame: Baseline, 6-month, 1-year, 2-years]
  • Range of motion [Time frame: Baseline, 6-month, 1-year, 2-years]
  • Shoulder strength [Time frame: Baseline, 6-month, 1-year, 2-years]
  • Biomechanics and Muscle Activity [Time frame: Baseline and 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Nova Scotia Health Authority — Halifax

Identifiers

NCT: NCT05959733 · BioBridge

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗