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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
Sponsor:
Collaborators:
Medinova Clinics
Gelre Hospitals
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 21, 2018
Last Update Posted Date March 21, 2018
Estimated Study Start Date  ICMJE April 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
Official Title  ICMJE Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ankle Sprains
  • Talofibular; Sprain (Strain)
Intervention  ICMJE
  • Procedure: Internal Brace augmented ankle Ligament reconstruction
    internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
  • Procedure: Brostrom-Gould ankle Ligament reconstruction
    Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
Study Arms  ICMJE
  • Experimental: Intervention Group
    Internal Brace augmented ankle Ligament reconstruction
    Intervention: Procedure: Internal Brace augmented ankle Ligament reconstruction
  • Active Comparator: Control Group
    Brostrom-Gould ankle Ligament reconstruction
    Intervention: Procedure: Brostrom-Gould ankle Ligament reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Walter van der Weegen, Dr. +31 (0) 40 2864 280 w.vander.weegen@st-anna.nl
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03472404
Other Study ID Numbers  ICMJE W18.016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
Study Sponsor  ICMJE Walter van der Weegen
Collaborators  ICMJE
  • Medinova Clinics
  • Gelre Hospitals
Investigators  ICMJE
Principal Investigator: Walter van der Weegen, Dr. St. Anna Hospital
PRS Account St. Anna Ziekenhuis, Geldrop, Netherlands
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP