BioBrace vs Repair for Rotator Cuff Tears

Overseen By Sarah Remedios, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Osteoarthritis, Uncontrolled diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using BioBrace® (a surgical implant) for rotator cuff tears leads to better outcomes than the traditional repair method. Researchers aim to determine which approach more effectively prevents re-tears and improves shoulder strength, movement, and function. Suitable candidates include those with a large rotator cuff tear (more than 3 cm) involving two specific tendons, confirmed by an MRI. Participants will receive either the BioBrace® or a standard repair to evaluate which works best. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the BioBrace® implant has been used safely and effectively in various surgeries, such as rotator cuff repairs. In previous studies, only 5.1% of these procedures resulted in a re-tear, and just 2.6% required additional surgery. This indicates that the implant is generally well-tolerated and rarely necessitates further surgical intervention. The BioBrace® implant is designed to strengthen and support tissue healing, making it beneficial in surgeries like rotator cuff repairs.

Specific safety information for the traditional maximal repair method is not available in these sources. However, this method is commonly used and considered standard, suggesting that its safety is well understood. Patients should consult their healthcare provider to understand what these options might mean for them personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BioBrace treatment for rotator cuff tears because it offers a novel approach to healing. Unlike typical surgical repairs that only involve stitching the torn tendon back together, BioBrace uses a bioinductive implant designed to support and strengthen the repair by promoting natural tissue growth. This cutting-edge method could potentially lead to stronger, more resilient tendon healing and faster recovery times, setting it apart from current repair-only techniques.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

This trial will compare two treatment options for rotator cuff tears: Bridging Reconstruction using BioBrace® and Maximal Repair. Research has shown that BioBrace® can aid the healing process by strengthening shoulder repairs. Studies have found that using BioBrace® in rotator cuff surgeries can make the repair more stable and stronger, which is especially helpful in preventing re-tears, particularly with larger tears. Early findings suggest that BioBrace® aids in better recovery and improves shoulder movement. While more information is needed, the initial results are promising for those considering this option for rotator cuff repair. ^{1 2 3 4 5}

Who Is on the Research Team?

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority, Orthopaedic Surgeon

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific shoulder injury: large or massive rotator cuff tears involving two tendons, confirmed by MRI. It's not suitable for those who don't meet the tear size and location criteria.

Inclusion Criteria

I am over 18 years old.

I have a large shoulder tear involving two tendons, confirmed by MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either maximal repair or bridging reconstruction using BioBrace®

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for shoulder strength, range of motion, and other outcomes

6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular visits at 6-month, 1-year, and 2-year intervals

What Are the Treatments Tested in This Trial?

Interventions

• Bridging Reconstruction with BioBrace®
• Maximal Repair

Trial Overview The study compares two methods of treating severe shoulder tendon tears. One uses BioBrace® to bridge gaps in the torn tissue, while the other employs traditional maximal repair techniques. Success will be measured through re-tear rates and improvements in shoulder function.

How Is the Trial Designed?

Group I: Bridging Reconstruction using BioBrace Experimental Treatment 1 Intervention

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

Group II: Repair Active Control 1 Intervention

This group will undergo a rotator cuff repair procedure.

Bridging Reconstruction with BioBrace® is already approved in United States for the following indications:

Approved in United States as BioBrace for:

• Rotator cuff repair augmentation
• Revision rotator cuff surgery

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

ConMed Corporation

Industry Sponsor

Trials

9

Recruited

800+

CONMED Corporation

Industry Sponsor

Trials

11

Recruited

1,100+

Published Research Related to This Trial

The BioBrace™ is a novel bio-inductive scaffold designed for rotator cuff augmentation, combining the benefits of tissue induction and structural strength, which addresses the limitations of existing treatments.

This innovative implant uses a unique composition of type I collagen and bio-resorbable microfilaments, aiming to enhance tissue incorporation while providing immediate support during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. Cheesman, QT., Szukics, PF., Stark, M., et al.[2022]

In a randomized controlled trial involving 30 patients with massive rotator cuff tears, bridging reconstruction using dermal allograft resulted in significantly better patient-reported outcomes (WORC and DASH scores) at 2 years compared to maximal repair alone.

The bridging reconstruction group had a much lower retear rate (21%) and less progression to rotator cuff arthropathy compared to the maximal repair group (87%), indicating that this technique may offer a more effective long-term solution for large rotator cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Wong, I., Sparavalo, S., King, JP., et al.[2021]

A 63-year-old male experienced shoulder pain and stiffness after rotator cuff surgery with bioresorbable anchors, which was linked to a SARS-CoV-2 infection, suggesting a potential viral host response.

Histological analysis revealed a resorption reaction to the anchors and synovitis, but no infection was found, indicating that the symptoms may be related to the body's response to the virus rather than a direct complication from the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SARS-Cov-2 related shoulder pain and stiffness associated to humeral osteolysis after arthroscopic rotator cuff repair: A case report. Lante, E., Mahé, G., Jany, R.[2023]

In a study of 50 patients with massive irreparable rotator cuff tears, both superior capsular reconstruction (SCR) and bridging graft (BG) techniques showed similar clinical outcomes after 2 years, with no significant differences in shoulder function scores.

MRI results at 12 months indicated that 75% of SCR grafts and 64% of BG grafts were intact, suggesting that the choice between SCR and BG does not significantly affect short-term graft integrity or clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graft Healing Is More Important Than Graft Technique: Superior Capsular Reconstruction Versus Bridging Grafts-A Prospective Randomized Controlled Trial. Ono, Y., LeBlanc, J., Bois, AJ., et al.[2022]

In a study of 39 patients with massive irreparable rotator cuff tears, the implantation of a biodegradable subacromial spacer significantly improved shoulder function, with increases in range of motion and Constant scores observed at an average follow-up of 32.8 months.

The procedure was safe, with no major complications reported, although one patient required revision due to spacer migration, indicating that while effective, careful monitoring is necessary post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Subacromial Spacer Implantation in Patients With Massive Irreparable Rotator Cuff Tears: Clinical and Radiographic Results of 39 Retrospectives Cases. Deranlot, J., Herisson, O., Nourissat, G., et al.[2022]

The biodegradable sub-acromial spacer (InSpace™) implantation in 20 patients with massive irreparable rotator cuff tears showed significant improvement in shoulder function over 3 years, with the Constant score increasing from 33.4 to 65.4 points.

The procedure was found to be low-risk and simple, with sustained pain relief and functional improvements in daily activities and motion, indicating its efficacy as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Senekovic, V., Poberaj, B., Kovacic, L., et al.[2022]

A survey of 260 arthroscopic shoulder surgeons revealed a significant decrease in the use of superior capsular reconstruction (SCR) for rotator cuff repair over the past 5 years, with many citing suboptimal published outcomes and lack of perceived patient benefit as reasons for this decline.

Conversely, the use of bioinductive grafts is on the rise, particularly among surgeons performing over 100 rotator cuff repairs annually, although most still use these grafts in less than 10% of their cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Number of Surgeons Using Superior Capsular Reconstruction for Rotator Cuff Repair Is Declining. Hankins, AC., Griffin, JW., Taliaferro, JP., et al.[2023]

The dual-suspensory reconstruction technique using patellar tendon (PT) grafts showed superior biomechanical properties and better healing outcomes compared to routine patch repair and fascia lata (FL) grafts in a study involving 72 rabbits with massive rotator cuff tears.

At 12 weeks, the PT grafts demonstrated higher failure loads and improved interface healing, indicating that this method could enhance treatment for massive rotator cuff tears in humans, suggesting a need for further clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical and Histological Results of Dual-Suspensory Reconstruction Using Banded Tendon Graft to Bridge Massive Rotator Cuff Tears in a Chronic Rabbit Model. Xu, J., Han, K., Ye, Z., et al.[2022]

The Sharc-FT® system for arthroscopic rotator cuff tear repair showed significant improvement in patient outcomes, with the Constant score increasing from a mean of 24.5 preoperatively to 86.9 at 12 months post-surgery, based on a study of 34 patients over an average follow-up of 18.6 months.

This new repair system enhances the biomechanical stability of the repair by allowing for transosseous sutures with cortical fixation, which may improve healing and reduce complications, although further evaluation is needed to assess the incidence of retears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rotator cuff tear repair with a new arthroscopic transosseous system: the Sharc-FT(®). Baudi, P., Rasia Dani, E., Campochiaro, G., et al.[2022]

In cases of failed rotator cuff repairs, particularly medial failures, using patch augmentation with an absorbable synthetic scaffold can improve the healing environment and reinforce weak areas of the cuff.

The study outlines a detailed revision technique that enhances the mechanical stability of the rotator cuff, potentially leading to better outcomes in patients with compromised healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision of Medial Rotator Cuff Failure Augmented With a Bioabsorbable Patch. Buess, E., Hackl, M., Buxbaumer, P.[2020]

Citations

1. conmed.com conmed.com/en/products/implants-and-suture-anchors/biobrace/biobrace-data

BioBrace Clinical Evidence: Reinforced Healing This platform technology can strengthen your repair and optimize your healing in shoulder, knee, and foot & ankle procedures.

2. conmed.com conmed.com/en/data-repository

Clinical Data Repository This study investigates maximum load and stiffness in an ACL reconstruction with and without augmentation using a reinforced implant (BioBrace®, CONMED) at ...

3. ctv.veeva.com ctv.veeva.com/study/biobrace-r-implant-for-arthroscopic-repair-of-full-thickness-rotator-cuff-tears

BioBrace® Implant for Arthroscopic Repair of Full Thickness ... This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05959733

Study Details | NCT05959733 | Maximal Repair Versus ... 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 ...

5. conmed.com conmed.com/-/media/conmed/documents/clinical/retrospectivechartreviewtoevaluateclinicaloutcomesofbiobrace_whitepaper.ashx

Retrospective Chart Review to Evaluate Clinical Outcomes ... As seen in the literature, rotator cuff repair retear rate increases as tear size increases and can range anywhere from 7.2% to. 94%.21 One review found that ...