inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG (STRONG)
Primary Purpose
Ankle Sprains, Talofibular; Sprain (Strain)
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Internal Brace augmented ankle Ligament reconstruction
Brostrom-Gould ankle Ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprains
Eligibility Criteria
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.
Sites / Locations
- Gelre ZiekenhuisRecruiting
- MedinovaRecruiting
- St Anna hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Internal Brace augmented ankle Ligament reconstruction
Brostrom-Gould ankle Ligament reconstruction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03472404
First Posted
March 2, 2018
Last Updated
June 1, 2023
Sponsor
Walter van der Weegen
Collaborators
Medinova Clinics, Gelre Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03472404
Brief Title
inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
Acronym
STRONG
Official Title
Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walter van der Weegen
Collaborators
Medinova Clinics, Gelre Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Talofibular; Sprain (Strain)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Internal Brace augmented ankle Ligament reconstruction
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Brostrom-Gould ankle Ligament reconstruction
Intervention Type
Procedure
Intervention Name(s)
Internal Brace augmented ankle Ligament reconstruction
Intervention Description
internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
Intervention Type
Procedure
Intervention Name(s)
Brostrom-Gould ankle Ligament reconstruction
Intervention Description
Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
Primary Outcome Measure Information:
Title
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walter van der Weegen, Dr.
Phone
+31 (0) 40 2864 280
Email
w.vander.weegen@st-anna.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter van der Weegen, Dr.
Organizational Affiliation
St. Anna Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelre Ziekenhuis
City
Apeldoorn
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Bullens, MD
Facility Name
Medinova
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Schrier, MD, PhD
Facility Name
St Anna hospital
City
Geldrop
ZIP/Postal Code
5664EH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter van der weegen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
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