Used in over 40 procedures
BioBrace® Reinforced Implant is a versatile, highly differentiated augmentation solution. This platform technology can strengthen your repair and optimize your healing in shoulder, knee, and foot & ankle procedures.1,2
But don't just take our word for it - click on the peer-reviewed literature below to learn more:
1 K203267 – 510(k) Clearance Letter - The BioBrace® Implant.
2 Based on preclinical animal data.
Publications
Publications
Key Takeaways:
- Persistent High Re-Tear Rates in RCR: Despite the widespread use of rotator cuff repair (RCR) procedures, re-tear rates remain high, especially in massive and revision tears, prompting the exploration of new reinforcement methods.
- Advancements in Soft Tissue Scaffolds: The BioBrace® scaffold, a bio-composite open porous 3D structure, provides both biological and mechanical support, aiding in soft tissue generation and acting as a reinforcing element to reduce the risk of suture-tendon pull-through and re-tears.
- Comparative Advantages of BioBrace®: Offering a combination of the healing properties of Regeneten and the structural strength of dermal allografts, the BioBrace® demonstrates improved structural strength and gradual resorption over time, positioning it as a superior option for RCR augmentation.
Key Takeaways:
- Growing Interest in Biologics and Augmentations for RCR: There is increasing interest in using biologics and augmentations for rotator cuff repair (RCR) to improve outcomes and reduce re-tear rates, addressing a significant clinical challenge.
- Limitations of Current Augmentation Methods: Existing bio-inductive implants often lack the necessary structural strength at the time of implantation, which is crucial for providing additional support and reducing the risk of suture-tendon pull-through and failure.
- Advantages of BioBrace® for RCR Augmentation: The BioBrace® bio-composite scaffold offers a reproducible technique for RCR augmentation, combining immediate structural strength with enhanced healing properties. This approach can increase tendon thickness, prevent tissue gapping, and ultimately resorb, leaving behind stronger native tissue and reducing the likelihood of re-tears.
Key Takeaways:
- Increasing Use of Synthetic and Biological Implants: There is a growing trend in using synthetic and biological implants to augment repairs and reconstructions for biomechanical reinforcement and to promote native healing responses, aiming to hasten rehabilitation.
- BioBrace® in MCL Repairs and Reconstructions: The BioBrace® bio-composite scaffold is discussed in the context of knee medial collateral ligament (MCL) repairs and reconstructions, highlighting its utility in open, mini-open, and allograft reconstruction techniques.
- Advantages of BioBrace® for MCL Treatment: BioBrace® offers significant benefits due to its combination of biological and synthetic properties, providing a robust scaffold for native healing and supplementary tensile strength, which has been shown to enhance repair and incorporation in both acute and chronic MCL injuries.
Key Takeaways:
- Promising Results with BioBrace® for Revision Rotator Cuff Repair: The use of BioBrace®, a novel biocomposite scaffold, in a case of recurrent large type-II rotator cuff tear with grade 3 Goutallier fatty infiltration showed significant evidence of healing, incorporation, and remodeling at 10 months post-procedure, with MRI results indicating functional tissue growth.
- Significant Improvement in Patient Outcomes: At one year post-operation, the patient demonstrated full range of motion, 4/5 supraspinatus strength, and minimal pain or discomfort, with substantial improvements in VAS, ASES, and SANE scores, suggesting effective recovery and enhanced quality of life.
- BioBrace® as a Superior Alternative to Traditional Methods: BioBrace® provides a supportive scaffold for new tissue formation, offering both biological and structural benefits, making it a potential alternative to traditional dermal grafting for patients with poor tissue quality, particularly in revision rotator cuff repairs.
Key Takeaways:
- Effective Augmentation with BioBrace® for Achilles Tendon Repair: In a case of a midsubstance chronic 'cavitation' tear of the Achilles tendon, the BioBrace® implant was used to augment the repair, demonstrating significant improvements in function and healing. Six months post-surgery, the MRI showed near-complete fill-in of the defect with new tendon-like tissue integrated with the native tendon.
- Accelerated Recovery and Improved Tissue Quality: Augmenting the repair with BioBrace® may accelerate recovery and improve the ultimate quality of the healed tendon tissue. The patient exhibited excellent range of motion and the ability to perform a double leg hop six months post-operation, indicating a successful recovery.
- BioBrace® as a Promising Solution for Chronic Achilles Ruptures: Chronic Achilles tendon ruptures pose significant challenges due to poor tissue quality and large gaps. BioBrace®, with its structural strength and bioinductivity, can bridge these gaps and promote the formation of new native tissue, offering a potential solution where traditional methods fall short.
Key Takeaways:
- Challenges in Distal Biceps Repair: Distal biceps tendon ruptures, though rare, can significantly impair supination and elbow flexion strength, especially in severe cases with poor tissue quality, necessitating effective augmentation techniques.
- Limitations of Current Augmentation Methods: Existing methods often fall short due to issues like failure to incorporate, lack of structural strength, and technical complexity, highlighting the need for better solutions.
- Advantages of BioBrace®: The BioBrace® scaffold, with its open pore biocomposite design, offers a combination of strength and biological support, increasing tendon thickness and improving structural integrity within weeks, thus reducing the likelihood of re-tears and restoring native tendon function more effectively than other soft tissue augments.
Key Takeaways:
- BioBrace® for Lower Extremity Augmentation: While bioinductive implants are popular for upper extremity injuries, their use in lower extremity settings, such as midsubstance patellar tendon and retinacular augmentation, is less documented. This paper details their application in these challenging scenarios.
- Augmentation Techniques for Patellar Tendon and Retinaculum: BioBrace® was used in two key repair locations: a 23x30mm implant augmented the midsubstance patellar tendon by sandwiching the tendon remnants, and a 5x250mm implant augmented the medial and lateral retinaculum by extending from the gutters to the patellar tendon juncture.
- Enhanced Healing and Stability: Augmenting chronic or diseased tissue with BioBrace® provides a reinforced healing environment, promoting cellular infiltration and protecting the repair. Specifically, augmenting the retinaculum with BioBrace® can increase patellar stability and realignment, supporting better surgical outcomes.
Key Takeaways:
- BioBrace® Enhances ACL Graft Healing: In ACL reconstructions, BioBrace® not only provides mechanical reinforcement to the graft but also biologically enhances graft healing, aiding in better integration and tissue remodeling.
- Advantages Over Internal Braces: While internal braces add structural support to ACL reconstructions, they do not increase collagen content or support the biological healing and integration of the graft. BioBrace® addresses these limitations effectively.
- Biomechanical and Biological Benefits of BioBrace®: BioBrace®'s biomechanical properties allow it to share loads and assist in the biological healing of ligaments. It gradually resorbs as the tissue remodels, providing a dual benefit of mechanical support and enhanced biologic healing in ACL reconstructions.
Key Takeaways:
- BioBrace® Augmentation in ACL Reconstruction: BioBrace® is utilized to augment ACL reconstruction in cases of multiligamentous knee injuries (MLKI), providing biomechanical support at the time of surgery while facilitating soft tissue remodeling. It addresses concerns such as allograft strength, healing potential, and graft size adequacy.
- Versatile Graft Preparation Methods: The surgical technique includes two methods for graft preparation: bone-patellar tendon-bone (BTB) and soft tissue grafts. This flexibility allows surgeons to adapt to varying patient conditions, such as poor tissue quality or insufficient graft size.
- Benefits of BioBrace® in ACL Reconstruction: By reinforcing tendons and ligaments with BioBrace®, surgeons enhance the structural integrity and healing potential of ACL reconstructions. This approach supports better outcomes in challenging cases where traditional methods may not suffice.
Key Takeaways:
- BioBrace® Augmentation in ACL Reconstruction: In ACL reconstruction using a bone-tendon-bone (BTB) allograft, BioBrace® is sutured onto the graft to reinforce the ligament structure. This biocomposite scaffold aims to accelerate healing, enhance biologic integration, and improve overall mechanical strength of the graft.
- Comprehensive Approach to ACLR: BioBrace® not only provides mechanical reinforcement to reduce re-rupture risk but also enhances graft healing and remodeling. Unlike traditional methods, BioBrace® incorporates biologics that support tissue integration, potentially leading to better patient-reported outcomes post-surgery.
- Surgical Technique and Benefits: The described technique outlines how BioBrace® is integrated into ACL reconstruction to support the BTB allograft, emphasizing its role in improving both the structural and biological aspects of the repair. This approach represents a comprehensive strategy to optimize ACL reconstruction outcomes.
Key Takeaways:
- 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.
Key Takeaways:
- Limited Restoration with UCL Repair Alone: UCL Repair alone did not restore valgus opening compared to native UCL and was similar to torn UCL.
- Enhanced Stability with BioBrace® Augmentation: UCL Repair augmented with BioBrace® restored UCL valgus opening similar to native UCL and better than UCL repair alone.
Key Takeaways:
- Supplemental Strength with BioBrace®: BioBrace® provides supplemental strength to an MPFL Repair.
- Comparable Biomechanics with BioBrace® Augmentation: MPFL Repair augmented with BioBrace® demonstrated similar results to native MPFL biomechanics.
- Consistent Stiffness at Displacement: MPFL Repair with BioBrace® provided consistent stiffness at clinically relevant displacement.
- Enhanced Consistency Over Allograft: MPFL Repair with BioBrace® provided a more consistent size and fixation relative to the MPFL Reconstruction with allograft Semi-T.
Key Takeaways:
- Treatment Options for Patellar Instability: Treatment for patellar instability ranges from non-surgical treatment to full allograft reconstruction. MPFL repair is an option, however an isolated MPFL repair has been shown to be insufficient to prevent recurrent instability, often requiring a full reconstruction.
- Advantages of BioBrace® Augmentation: Augmenting an MPFL repair with BioBrace® offers several advantages over Semi-T reconstruction: it is off-the-shelf and shelf-stable, provides consistent size and shape as opposed to allograft, has comparable pullout strength to Semi-T, and carries minimal risk of adverse immune response.
- Benefits of Single-Incision Technique: The single-incision technique has several benefits over the two-incision technique, including similar total incision length, direct visualization of the augment, and simplified docking and tensioning of the augment.
- Aggressive Rehabilitation with BioBrace®: Due to the fixation strength and biomechanical properties of BioBrace®, the senior author has adopted an aggressive rehabilitation protocol as described in the paper.
