BioBrace^® Reinforced BioInductive Implant: Backed by Clinical Evidence

• BioBrace^® offers a promising alternative to non-absorbable suture augmentation by:
  • Reducing stress shielding
  • Avoiding complications from large polymer anchors
  • Supporting early mobilization and return to sport
• Early outcomes show excellent functional recovery, minimal complications, and high patient satisfaction.

• This technique offers a biomechanically robust and biologically active alternative to traditional MPFL reconstruction.
• The reinforced bioinductive implant provides early mechanical strength and supports tissue healing.
• The double-bundle docking technique mimics native MPFL anatomy.

Study inclusion criteria: High-risk patients

• Large (>3cm) and massive (>5cm, >= 2 tendons) rotator cuff tear
• Anterior to Posterior tear >2.5cm
• Infraspinatus fatty atrophy
• At least one co-morbidity

Lower retear rate in rotator cuff repair with BioBrace^® augmentation

46/49 (94.1%) patients augmented with BioBrace^® healed at minimum 1 year follow-up (avg: 26.1 months).¹

According to a white paper based on meta-analysis and a retrospective review of data, rotator cuff retear rates after surgical repair can range from 7.2% to 94% and most rotator cuff repairs fail within the first 6 months.²

Improved patient reported outcomes and range of motion

PROMs/ROM outcomes improved, VAS, and ASES scores statistically significantly improved at all time points (3m, 6m, 12cm) compared to baseline (p < 0.001).

Citations

¹McMillan S, Ford E, Bishai SK. Favorable Early Patient-Reported Outcome Measures and Clinical Retear Rates in High-Risk Rotator Cuff Repairs Augmented with a Reinforced Bio-Inductive Implant at One-Year Follow Up

²A Retrospective Chart Review to Evaluate Clinical Outcomes of the BioBrace^® Implant, https://www.conmed.com/-/media/conmed/documents/clinical/retrospectivechartreviewtoevaluateclinicaloutcomesofbiobrace_whitepaper.ashx

• This technique offers a streamlined, reproducible approach to MPFL repair augmentation.
• BioBrace^® can provide both mechanical reinforcement and biologic integration, which could support early mobilization and return to activity.
• The single-incision method improves surgical control and may reduce complications associated with graft malposition or overtensioning.
• Preliminary outcomes are promising, with no recurrent dislocations and full return to activity by 6 months post-operatively.

• BioBrace^® augmented MPFL repairs provides similar strength to an intact MPFL.
• Augmentation with BioBrace^® provides an alternative solution for patient indications where a reconstruction is not necessary, but surgical intervention is required.

• Bioinductive scaffold augmentation in UCL repair is biomechanically feasible and enhances initial joint stability.
• May allow for earlier rehabilitation while avoiding risks associated with nonabsorbable materials.
• Further clinical and comparative studies are needed to assess long-term outcomes and validate superiority over existing techniques.

• BioBrace^® augmentation in BTB allograft ACLR is a promising technique.
• Technique is reproducible and adaptable.
• Enhances graft strength and healing without donor site morbidity.

• BioBrace^® augmentation in ACL reconstruction is a promising technique for improving graft strength and healing, especially in MLKI.
• Offers a balance of mechanical reinforcement and biological integration.
• Technique is versatile and reproducible, with potential applications beyond ACLR.

• Comparable Pullout Strength: In a biomechanical cadaveric model comparing the BioBrace^® implant and a semitendinosus graft for augmenting MPFL repair, there was no statistically significant difference in pullout strength between the two groups. This suggests that the BioBrace^® implant can offer comparable mechanical stability to traditional graft methods.
• Challenges Addressed by BioBrace^®: The BioBrace^® implant addresses limitations of current methods by providing both healing properties to stimulate native tissue healing and biomechanical strength to support MPFL repair. This dual functionality aims to reduce the risk of recurrent patellar instability and progressive soft tissue and cartilage injuries.
• Advantages Over Semitendinosus Graft: The semitendinosus graft showed a higher failure rate (67% by anchor pullout) while BioBrace^® provided consistent fixation with minimal failures. This highlights BioBrace^® as a reliable alternative for enhancing MPFL repair outcomes.

• BioBrace^® augmentation is a promising technique for ACL reconstruction.
• Technique is reproducible and adaptable to various graft types.

• MRI at 1 year has demonstrated restoration of the native biceps tendon and showed an increase in tendon diameter from 5mm at pre-op to 8mm at 1 year post op.
• Enhanced Healing: BioBrace^® promotes a beneficial healing environment and provides structural support.
• Mechanical Support: Provides load-sharing strength at time zero, reducing re-rupture risk.
• Versatility: Suitable for both acute and chronic distal biceps injuries.
• Improved Outcomes: Early results show promising restoration of tendon strength and diameter.
• Future Potential: BioBrace^® may be widely applicable in biceps tendon rupture.

• Enhanced Healing: BioBrace^® promotes rapid cellular infiltration and tissue growth.
• Mechanical Support: Provides load-sharing strength at time zero, reducing re-rupture risk.
• Improved Outcomes: Early results show promising restoration of tendon strength.
• Future Potential: BioBrace^® may be widely applicable for various tendon and ligament repairs.

• High Re-Rupture Rates in Achilles Tendon Injuries: Achilles tendon ruptures account for 20% of all large tendon ruptures, with re-rupture rates ranging from 2.1% to 8.8%. Ineffectual management can lead to significant loss in push-off strength and overall ankle function, highlighting the need for improved treatment strategies.
• Promise of BioInductive Augmentation in Achilles Tendon Repair: The field of orthopedic surgery is increasingly interested in bioinductive augmentation to enhance outcomes in Achilles tendon repairs, especially in patients with poor tendon tissue. The BioBrace^®, reinforced bioinductive implant, made of type I collagen and bioresorbable PLLA microfilaments, provides immediate strength and promotes new tissue growth during its resorptive phase.
• Innovative Technique Using BioBrace^® for Achilles Tendon Repair: A technique for augmenting acute Achilles tendon repair with the BioBrace^® reinforced bioinductive implant shows promise. This approach provides additional structural support and promotes new tissue growth, potentially benefiting active individuals aiming for a quick return to physical activities. Additionally, the cost of revision surgery for failed soft tissue repairs, such as Achilles tendon ruptures, is significant in terms of healthcare dollars and toll on the patient. Given this, for the correctly indicated patient, using an RBI for soft tissue reinforcement can add significant benefit and decrease failures in patients with poor tissue quality.

• The BioBrace^® effectively augmented the repair of a chronic Achilles tendon rupture, promoting both mechanical stability and biological healing.
• Early mobilization was possible due to the strength of the repair construct.
• The implant showed promising integration and tissue regeneration on imaging.
• This case supports the potential of biocomposite scaffolds in managing complex tendon injuries, though larger studies are needed for validation.

• The BioBrace^® scaffold provided both mechanical support and biological integration, addressing key failure points in rotator cuff repair.
• Imaging and arthroscopic findings confirmed scaffold incorporation and tissue remodeling.
• The patient achieved near-normal shoulder function at 1-year post-op.

• BioBrace® offers a fully resorbable scaffold that supports both early mechanical stability and long-term biologic healing.
• Augmentation is particularly suited for revision cases and large/massive tears with poor tissue quality.

• Enhanced Healing: BioBrace^® scaffold promotes soft-tissue regeneration, improving recovery outcomes.
• Mechanical Support: Provides necessary structural support during the healing process.
• Versatile Application Suitable for both acute and chronic MCL injuries, offering flexibility in treatment options.
• Early Mobilization: Allows for early range of motion and weight bearing, facilitating quicker rehabilitation.

• BioBrace^® is a novel bio-composite scaffold combining:
  • Type I collagen (bioinductive, 80% porous) designed to induce new tissue ingrowth for thicker tendon tissue.
  • PLLA microfilaments for mechanical strength at time zero and throughout the healing process. The PLLA has strength for up to 2 years before fully resorbing