Chronic Ankle Instability, Surgical Repair: Open Versus Closed (CAISR)

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    44
  • sponsor
    Gwendolyn Vuurberg
Updated on 25 February 2022

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 Brstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Brstrom 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).

Details
Condition Chronic Ankle Instability
Treatment Surgical stabilization
Clinical Study IdentifierNCT02998333
SponsorGwendolyn Vuurberg
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are 18 years or older
Experience pain and/or a sensation of instability during sports and/or daily activity
Isolated lateral ankle instability
Planned for surgical repair of the ATFL
At least one previous episode of an ankle inversion sprain
Complaints for at least 6 months
Failed previous conservative treatment

Exclusion Criteria

Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray according to standard protocol)
Foot or ankle fracture in past
Previous foot or ankle surgery
ROM restriction of >10 degrees
Medial instability
Severe misalignment
Ankle/foot deformities (e.g. severe flat foot)
Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid Arthritis)
(general) Hyper laxity
Inability or unwillingness to provide consent
Present factors that may cause difficulty of follow-up
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note