An interventional study of Internal Brace augmented ankle Ligament reconstruction and Brostrom-Gould ankle Ligament reconstruction in Ankle Sprains and Talofibular; Sprain (Strain), sponsored by Walter van der Weegen. Recruiting at 3 sites in Netherlands. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Walter van der Weegen · Not applicable, Interventional, and Treatment
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.
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.
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's planned enrollment of 42 is below the median of 54 across 270 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →This is the only study on the registry with Walter van der Weegen as lead sponsor.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Internal Brace augmented ankle Ligament reconstruction
Procedure: Internal Brace augmented ankle Ligament reconstruction
Brostrom-Gould ankle Ligament reconstruction
Procedure: Brostrom-Gould ankle Ligament reconstruction
internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months
Patient reported outcome measure, consists of 42 items, each item is scored in a 5-point likert scale
Time frame: pre-operative, post-operative at 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2018 (actual). Primary completion is estimated for Dec 2023, 62 months after the start.
Of 138 non-industry interventional studies with no phase under Ankle Injuries, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 62 months is above that.
Counting every sponsor, half of 141 studies reached it within 9 months; a quarter within 4 and three quarters within 31.
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