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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the treatment Bridging Reconstruction with BioBrace® for rotator cuff tears?

Research suggests that using a bio-composite scaffold like BioBrace can help strengthen rotator cuff repairs by combining tissue growth and structural support, potentially reducing the risk of retears compared to traditional methods. ^{1 2 3 4 5}

Is BioBrace safe for use in humans?

The BioBrace is designed to be a safe option for rotator cuff repair, combining strength and tissue growth support, but like any medical implant, it may carry some risks such as foreign body reactions. ^{1 2 6 7 8}

How is the BioBrace treatment for rotator cuff tears different from other treatments?

The BioBrace treatment is unique because it combines the benefits of bio-induction (encouraging new tissue growth) and structural strength in a single implant, using a bio-composite scaffold made of type I collagen and bio-resorbable microfilaments. This approach aims to reduce the high retear rates seen with traditional maximal repair methods by providing both immediate support and promoting long-term healing. ^{1 2 5 9 10}

Research Team

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority, Orthopaedic Surgeon

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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 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 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]

References

1. United States 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. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Graft Healing Is More Important Than Graft Technique: Superior Capsular Reconstruction Versus Bridging Grafts-A Prospective Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Number of Surgeons Using Superior Capsular Reconstruction for Rotator Cuff Repair Is Declining. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision of Medial Rotator Cuff Failure Augmented With a Bioabsorbable Patch. [2020]

6. France pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. [2022]

7. Netherlands 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. [2023]

8. United States 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. [2022]

9. United States 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. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

The rotator cuff tear repair with a new arthroscopic transosseous system: the Sharc-FT(®). [2022]