Chronic Ankle Instability, Surgical Repair: Open Versus Closed

Status Recruiting

Clinical Trial Summary

Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of patients with lateral ankle ligament injuries, chronic lateral ankle instability may be present. If conservative treatment fails, instability is treated surgically. Anatomic repair (also known as the Bröstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Bröstrom started out as an open technique and is now also performed arthroscopically. Both approaches are considered standard care and provide good results. Which approach is best, has not yet been researched. In this study it is hypothesized arthroscopic repair provides better functional outcome compared to open repair during short term follow-up. Objective: The main objective of this study is to compare the functional outcome after arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and open ligament repair. Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All patients willing to participate, from an age of 18 years old, with persisting ankle instability for at least 6 months, eligible for anatomic repair. Intervention: Both groups of patients are surgically treated with anatomic repair of the anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by the open approach. Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important Change = 10 points; 2 per subscale).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02998333
Study type	Interventional
Source	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact	Gwendolyn Vuurberg
Phone	+31(0)205662474
Email	g.vuurberg@amc.uva.nl
Status	Recruiting
Phase	N/A
Start date	January 2017
Completion date	August 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Chronic Ankle Instability, Surgical Repair: Open Versus Closed — CAISR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms