Health TrialsbyHealthPanel

Maximal Repair Versus Bridging Reconstruction with BioBrace®

ConditionsRotator Cuff TearsBioinductive Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

glenohumeral osteoarthritis

Western Ontario rotator cuff score >60

uncontrolled diabetes (Hgb A1C >7%)

pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bridging Reconstruction using BioBrace

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RepairActive comparator 1 intervention
Group B: Bridging Reconstruction using BioBraceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

Acromiohumeral Distance

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

Time frame
2 year
2

Muscle Atrophy

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

Time frame
2 year
3

Fatty Infiltration

Fatty infiltration using the Goutallier classification will be used and identified

Time frame
2 year
4

Healing Rate

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

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

CONMED Corporation

Collaborator

Source ClinicalTrials.gov
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