inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG (STRONG)
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|ClinicalTrials.gov Identifier: NCT03472404|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ankle Sprains Talofibular; Sprain (Strain)||Procedure: Internal Brace augmented ankle Ligament reconstruction Procedure: Brostrom-Gould ankle Ligament reconstruction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Intervention Group
Internal Brace augmented ankle Ligament reconstruction
Procedure: Internal Brace augmented ankle Ligament reconstruction
internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
Active Comparator: Control Group
Brostrom-Gould ankle Ligament reconstruction
Procedure: Brostrom-Gould ankle Ligament reconstruction
Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
- Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months [ Time Frame: pre-operative, post-operative at 12 months ]Patient reported outcome measure, consists of 42 items, each item is scored in a 5-point likert scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472404
|Contact: Walter van der Weegen, Dr.||+31 (0) 40 2864 firstname.lastname@example.org|
|Principal Investigator:||Walter van der Weegen, Dr.||St. Anna Hospital|