Health TrialsbyHealthPanel

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorCONMED Corporation

About this trial

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female 40 to 70 years old

Tear of the supraspinatus and/or infraspinatus tendons

Tear size ≥ 2 cm and < 5 cm

Chronic shoulder pain ≥ 3 months

Disqualifiers

Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy

Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)

Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator

Oral steroid use or steroid injection within 6 weeks prior to surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.

    Device

    An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.

  • Arthroscopic rotator cuff repair

    Procedure/Surgery

    An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Treatment groups

268 Participants
are divided into 2 treatment groups
Group A: BioBrace Augment GroupExperimental treatment 1 intervention
Group B: Repair Only GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

6 Month Retear Rate

The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.

Time frame
6 months post-op

Secondary outcomes

1

12 Month Retear Rate

The between-group difference in radiological incidence (MRI) of Sugaya Type IV or V full-thickness discontinuity at postoperative Month 12.

Time frame
12 months post-op
2

Single Assessment Numeric Evaluation (SANE)

Adjusted mean between-group difference in SANE score from baseline to 6 weeks, 3-, 6-, and 12-months post-op

Time frame
Baseline, 6 weeks, 3-, 6-, and 12-months post-op
3

Western Ontario Rotator Cuff Index (WORC)

Adjusted mean between-group difference in WORC score from baseline to 6 weeks, 3-, 6-, and 12-months post-op

Time frame
Baseline, 6 weeks, 3-, 6-, and 12-months post-op
4

EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)

Adjusted mean between-group difference in health-related, quality of life from baseline to 6 weeks, 3-, 6-, and 12-months post-op

Time frame
Baseline, 6 weeks, 3-, 6-, and 12-months post-op

Other outcomes

Sponsors and contacts

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

CONMED Corporation

Lead sponsor

Source ClinicalTrials.gov
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