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inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG (STRONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03472404
Recruitment Status : Not yet recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Medinova Clinics
Gelre Hospitals
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients diagnosed with chronic lateral ankle instability (multiple ankle inversion trauma within 12 months and symptoms present >1 year). Lateral ankle instability is present if the patient complains of giving way of the ankle and has positive signs of ankle instability during physical exam (talar tilt score of >15 degrees compared to contralateral ankle or anterior drawer test score of >10mm compared to the contralateral ankle.
  • Conservative therapy has failed.
  • Normal foot and ankle anatomy as determined by orthopedic surgeon.
  • Patients in whom their ankle symptoms interfere with their physical activities.
  • Patients with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique.
  • BMI ≤30
  • Patients who are able and willing to undergo ankle surgery.
  • Patients who are able and willing to comply with the rehabilitation protocol in any of the study physiotherapy centers.
  • Patients who are able and willing to return for follow-up evaluations.
  • Patients with sufficient understanding of the Dutch language.

Exclusion Criteria:

  • Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc).
  • Patients with comorbidities, including musculoskeletal injuries or diseases in other joints than the affected ankle which limits their physical activity.
  • Ankle instability due to abnormal foot and ankle anatomy.
  • No objective or subjective ankle instability.
  • Previous ankle surgery.
  • Patients in which the contralateral ankle also shows lateral ankle instability.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03472404

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Contact: Walter van der Weegen, Dr. +31 (0) 40 2864 280

Sponsors and Collaborators
Walter van der Weegen
Medinova Clinics
Gelre Hospitals
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Principal Investigator: Walter van der Weegen, Dr. St. Anna Hospital

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Responsible Party: Walter van der Weegen, Principal Investigator, St. Anna Ziekenhuis, Geldrop, Netherlands Identifier: NCT03472404    
Other Study ID Numbers: W18.016
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries