75 Participants NeededMy employer runs this trial

Brostrom Repair for Chronic Ankle Instability

Recruiting at 1 trial location
SA
Overseen BySoheil Ashkani-Esfahani, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines different methods to address chronic ankle instability, a condition that causes the ankle to feel wobbly or weak. Researchers aim to compare the outcomes of two ankle surgeries: the standard Brostrom repair and an enhanced version called Brostrom repair with augmentation, which uses a special implant called BioBrace. They will assess how patients feel and function before and after these surgeries. Individuals who have experienced weak ankles for over three months, confirmed by a doctor, and have not undergone any previous ankle surgeries may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative surgical options for improving ankle stability.

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

Research has shown that the Brostrom repair with added support is generally safe. Studies indicate that enhancing the Brostrom repair with materials like suture tape leads to excellent outcomes. This method is considered as safe as the traditional Brostrom repair. Patients who received this treatment reported feeling better and returned to their activities sooner.

Additionally, open surgeries like the Brostrom method have proven effective and safe over time. These procedures help reduce pain and improve the quality of life for people with ongoing ankle instability. Overall, both the traditional Brostrom repair and the enhanced version are well-tolerated by patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic ankle instability because they offer potentially more robust repair options. The Augmented Brostrom Repair (ABR) is particularly intriguing as it enhances the standard Brostrom procedure with BioBrace, a bio-inductive scaffold that supports tissue healing and strength. This augmentation might lead to better outcomes in terms of stability and recovery time compared to the traditional method. Unlike the standard-of-care Brostrom repair, ABR could provide a more durable solution, reducing the risk of recurrence and improving patient mobility more effectively.

What evidence suggests that this trial's treatments could be effective for chronic ankle instability?

This trial will compare two methods for treating chronic ankle instability: the Standard Brostrom Repair (SBR) and the Augmented Brostrom Repair (ABR). Research has shown that a Brostrom repair with extra support, like the ABR, effectively treats chronic ankle instability. Studies indicate that adding this support improves ankle stability more than the standard method. Specifically, this enhanced repair significantly boosts ankle stability by improving scores on tests that measure ankle movement. Patient outcomes are similar, with both methods providing the same level of improvement. Additionally, patients report satisfaction and less pain after these procedures. In summary, the enhanced approach offers a strong option for better ankle support and recovery.12467

Are You a Good Fit for This Trial?

This trial is for people with chronic ankle instability who need surgical repair of their lateral ankle ligaments. Participants should be eligible for open Broström surgery and not have other major health issues or injuries that would affect healing.

Inclusion Criteria

Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms
I have had unstable ankles for over 3 months, confirmed by exam and imaging.
I am between 18 and 65 years old.
See 1 more

Exclusion Criteria

BMI >40
Neuromuscular disorders or non-adherence concerns
I have weakness or injury in my deltoid ligament.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open Broström repair with or without BioBrace® Implant, followed by 2 weeks of immobilization and accelerated rehabilitation protocols

2 weeks immobilization, followed by rehabilitation
1 visit (in-person) for surgery, followed by rehabilitation visits

Follow-up

Participants are monitored for safety and effectiveness post-surgery with clinical evaluations and biweekly electronic questionnaires

12 months
Visits at 2 weeks, 2 months, 6 months, and 12 months (in-person); biweekly electronic questionnaires

Open-label extension (optional)

Participants may continue to receive follow-up assessments if they have not returned to preoperative activity levels

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Brostrom repair with augmentation
  • Standard Brostrom Repair

Trial Overview

The study compares two types of ankle ligament repair surgeries: the standard Broström procedure versus the same procedure enhanced with a BioBrace implant, which may help support healing. Patients are assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Standard Brostrom Repair (SBR)Experimental Treatment1 Intervention
Group II: Augmented Brostrom Repair (ABR)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

CONMED Corporation

Industry Sponsor

Trials
11
Recruited
1,100+

Citations

Efficacy and safety of lateral ligaments augmentation ... - PMC

The results showed that lateral ligament augmentation significantly improved both TTA and ATT compared to modified Broström repair, indicating better mechanical ...

2.

orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/129921

COMBINATION OF MODIFIED BROSTRÖM PROCEDURE ...

Evaluate the outcomes of repairing the anterior talofibular ligament using open modified Brostrom repair with InternalBrace augmentation ...

Chronic lateral ankle instability: A systematic review on ...

The results indicate comparable patient outcomes regardless of the ligamentous repair technique utilized.

Lateral Ankle Instability Surgery:

Short- to Medium-term Outcomes After a Modified Broström. Repair for Lateral Ankle Instability With Immediate Postoperative Weightbearing. Am J Sports Med. 2014 ...

Outcomes Following Broström Repair with InternalBrace ...

Patients treated for ATFL injury of the lateral ankle with Broström repair with suture tape augmentation demonstrated similar clinical outcomes to those treated ...

Improved Outcome and Earlier Return to Activity After ...

In conclusion, suture tape augmentation showed excellent results and is a safe technique comparable to traditional Broström repair.

The Outcome of Modified Mini-Open Brostrom Gould Ankle ...

This paper suggests that chronic ankle instability repaired through the MMBG is associated with an overall improvement in pain levels and the ...