NCT03472404

inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG

Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Walter van der Weegen · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half of the patients will receive the standard Brostrom-Gould reconstruction followed by a standard revalidation protocol including 6 weeks of immobilisation, while the other half of the patients will receive the same operation augmented with internal brace followed by an accelerated rehabilitation protocol.

Detailed description

Ankle inversion trauma often leads to chronic ankle instability which can severely limit the patient during daily activities, including work and sports. When conservative treatment fails, surgical treatment in which the ruptured anterior talofibular ligament (ATFL) is reconstructed can be considered. Surgical treatment for ankle instability is associated with a relatively long rehabilitation due to the initial limited strength of the reconstructed ligament. This limited strength in the first weeks after surgery makes it necessary to protect the reconstructed lateral ankle ligament with immobilization. Usually a lower leg plaster is applied for six weeks. Due to the initial limited strength of the reconstructed ligament and the immobilization period itself, return to activities after surgery for this injury usually takes up to six months or even more. Therefore, surgical intervention is only indicated for patients who suffer chronic, recurrent ankle instability. With a new surgical technique, an internal brace is placed over the reconstructed lateral ankle ligament, thereby providing protection which makes immobilization in the postoperative weeks unnecessary. This allows an earlier start of the rehabilitation which might enhance ankle function postoperatively and allows earlier return to activities. Also, adding an internal brace to the reconstructed lateral ankle ligament might result in a lower recurrence rate of ankle instability compared to the current surgical procedure. Objective: To evaluate if patients with chronic, recurrent lateral ankle instability who are treated with surgical lateral ankle ligament repair protected with an internal brace, have significant better ankle function after surgery compared to patients treated with standard surgical lateral ankle ligament reconstruction without internal brace. The appropriately adapted rehabilitation for each surgery procedure is applied.

Conditions

• Ankle Sprains
• Talofibular; Sprain (Strain)

Interventions

Type	Name	Description
PROCEDURE	Internal Brace augmented ankle Ligament reconstruction	internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
PROCEDURE	Brostrom-Gould ankle Ligament reconstruction	Brostrom-Gould and standard revalidation including 6 weeks immobilisation.

Timeline

• Start date: 2018-10-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2018-03-21
• Last updated: 2023-06-05

Locations

3 sites across 1 country: Netherlands