Biobrace Augmentation for Kneecap Dislocation

(BioPPD Trial)

Overseen By Sarah Kerslake, BPT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Banff Sport Medicine Foundation

Disqualifiers: Previous dislocation, Osteochondral fracture, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to determine the ability of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. First-time patellofemoral dislocation is a significant problem, and the ramifications of recurrence for patients are substantial. Due to the multifactorial nature of the pathoanatomy of patellofemoral instability, it has been difficult to design trials that will show how interventions could affect the natural history of these young patients. No definitive studies have determined whether the surgical reconstruction of the MPFL in patients with mild to moderate pathoanatomic risk factors will decrease the re-dislocation rate after a first-time dislocation. In addition, to date, no synthetic option has provided both biology and strength for ligament augmentation. This innovation may allow for a minimalist approach to keeping the patella centred in the trochlear groove during the healing phase after a first-time dislocation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Biobrace Augmentation for kneecap dislocation?

The BioBrace™ scaffold, used in rotator cuff repairs, combines the benefits of promoting new tissue growth and providing structural strength, which may suggest its potential effectiveness in supporting knee stability after dislocation. ^{1 2 3 4 5}

How does Biobrace Augmentation treatment for kneecap dislocation differ from other treatments?

Biobrace Augmentation is unique because it uses a bioinductive scaffold made of type I collagen and bioresorbable microfilaments to support tissue regeneration and provide mechanical support, which is different from traditional surgical repairs that may not use such materials. This approach aims to enhance the natural healing process and potentially speed up rehabilitation compared to standard treatments. ^{4 6 7 8 9}

Research Team

Laurie A Hiemstra, MD, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for individuals aged 13-30 who have experienced their first kneecap dislocation within the last week. Participants must have growth plates that are closed or nearly closed, as confirmed by knee x-rays.

Inclusion Criteria

I am between 13 and 30 years old.

My kneecap was dislocated for the first time within the last week.

My knee x-rays show that my growth plates are closed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients undergo knee arthroscopy and MPFL repair augmented with Biobrace® synthetic ligament

2 weeks

1 visit (in-person)

Post-operative Monitoring

Patients are monitored for pain and medication use in the initial 14 days post-operative

2 weeks

Daily log book entries

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, and 24 months post-operative

24 months

3 visits (in-person)

Treatment Details

Interventions

• Biobrace Augmentation

Trial Overview The study tests if repairing the medial patellofemoral ligament (MPFL) and reinforcing it with a synthetic material called Biobrace® can reduce the chances of a dislocated kneecap happening again after the first incident.

Participant Groups

Group I: MPFL repair with Biobrace augmentation Experimental Treatment 1 Intervention

Patients presenting with first-time lateral patellofemoral dislocation within the previous 7 days will be offered a patellofemoral stabilization procedure, including knee arthroscopy and an MPFL repair augmented with Biobrace® synthetic ligament.

Who Is Running the Clinical Trial?

Banff Sport Medicine Foundation

Lead Sponsor

Trials

4

Recruited

160+

CONMED Corporation

Industry Sponsor

Trials

11

Recruited

1,100+

Findings from Research

In a study of 44 patients who underwent surgical treatment for knee dislocations, 93% were able to return to their preinjury activity levels or slightly lower after a mean follow-up of 10 years, indicating effective restoration of knee function.

However, 23% of these patients developed degenerative joint disease over the same period, highlighting a significant risk of long-term complications despite successful surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term followup of surgically treated knee dislocations: stability restored, but arthritis is common. Fanelli, GC., Sousa, PL., Edson, CJ.[2022]

The case report describes a rare instance of an open posterior knee dislocation accompanied by a ruptured patellar tendon and a tibial plateau fracture, highlighting the severity of such injuries.

Surgical treatment involved reducing the dislocation, fixing the fracture, and repairing the tendon, resulting in a successful outcome with full range of motion, demonstrating the efficacy of this surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open posterior dislocation of the knee with rupture of the patellar tendon and a tibial plateau fracture. Amar, MF., Chbani, B., Ammoumri, O., 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]

A 40-year-old male successfully underwent delayed allograft reconstruction of a multiligament knee injury with Internal Brace augmentation, leading to a return to work at 6 months post-surgery.

At 2 years follow-up, the patient showed no signs of knee instability, indicating the effectiveness of the surgical intervention despite a subsequent unrelated femur fracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supracondylar femur fracture following multiligament knee reconstruction with Internal Brace® augmentation: A case report. Rick Hatch, GF., Bolia, IK., Lindsay, A., et al.[2022]

In a five-year study of 150 patients with anterior cruciate ligament (ACL) ruptures, those who received augmentation with a patellar-ligament graft showed significantly better activity levels and knee function at both two and five years compared to those who had non-augmented repairs or repairs with a synthetic device.

The study concluded that non-augmented primary repairs should be avoided due to poor outcomes, and that repairs augmented with a patellar-ligament graft provide the best stability and function over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized study of three operations for acute rupture of the anterior cruciate ligament. Five-year follow-up of one hundred and thirty-one patients. Grøntvedt, T., Engebretsen, L., Benum, P., et al.[2019]

Most medial collateral ligament (MCL) injuries are treated nonoperatively, with surgery typically reserved for grade III injuries that do not respond to conservative treatment.

The BioBrace, a bioinductive scaffold made of collagen and bioresorbable materials, is gaining popularity for enhancing MCL repairs and reconstructions by promoting healing and providing mechanical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Medial Collateral Ligament Augmentation With Bioinductive Scaffold: Surgical Technique and Indications. LeVasseur, MR., Uyeki, CL., Garvin, P., et al.[2022]

The InternalBrace™ technique allows for anatomic ligament repair with augmentation, promoting early mobilization and progressive strengthening of ligaments, which has shown successful applications in various ligaments including the ACL and lateral ankle ligaments.

This approach suggests a shift in orthopedic practice, where reconstruction is now considered a salvage procedure, reserved for cases where tissues do not heal properly after augmentation and repair, potentially reducing surgical morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of ligament augmentation with the InternalBrace™: the surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented. Mackay, GM., Blyth, MJ., Anthony, I., et al.[2022]

In a review of 104 severe knee sprains treated with a ligamentoplasty using a Kennedy polypropylene ligament augmentation device, 87% of athletes reported satisfaction with their functional outcomes after an average follow-up of 31 months.

Despite the overall positive results, 26% of cases were unsatisfactory, with some failures attributed to premature return to sports, highlighting the importance of timely stabilization and rehabilitation to prevent further injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Severe anterior sprains of the knee. Ligamentoplasty using the patellar tendon and reinforcement]. Malissard, M., Huguet, D., Nieto, H., et al.[2006]

ACL reconstruction is the most common surgical procedure for knee ligament injuries, particularly in athletes, but it faces challenges like graft rupture and residual laxity.

The article introduces a new technique using suture augmentation (InternalBrace) during ACL reconstruction, which aims to protect the graft during the healing process and potentially reduce the risk of future failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction With Suture Tape Augmentation: A Surgical Technique. Anderson, SR., Youssefzadeh, KA., Limpisvasti, O.[2020]

References

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

Long-term followup of surgically treated knee dislocations: stability restored, but arthritis is common. [2022]

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

Open posterior dislocation of the knee with rupture of the patellar tendon and a tibial plateau fracture. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Supracondylar femur fracture following multiligament knee reconstruction with Internal Brace® augmentation: A case report. [2022]

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

A prospective, randomized study of three operations for acute rupture of the anterior cruciate ligament. Five-year follow-up of one hundred and thirty-one patients. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Knee Medial Collateral Ligament Augmentation With Bioinductive Scaffold: Surgical Technique and Indications. [2022]

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

A review of ligament augmentation with the InternalBrace™: the surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented. [2022]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Severe anterior sprains of the knee. Ligamentoplasty using the patellar tendon and reinforcement]. [2006]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction With Suture Tape Augmentation: A Surgical Technique. [2020]