inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG

NCT03472404 | Unknown

• 1 other identifier: W18.016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

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.

Conditions

Ankle Sprains; Talofibular; Sprain (Strain)

Outcome Measures

Primary Outcomes (1)

• 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

  pre-operative, post-operative at 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Internal Brace augmented ankle Ligament reconstruction

Procedure: Internal Brace augmented ankle Ligament reconstruction

Control Group

ACTIVE COMPARATOR

Brostrom-Gould ankle Ligament reconstruction

Procedure: Brostrom-Gould ankle Ligament reconstruction

Interventions

Internal Brace augmented ankle Ligament reconstruction PROCEDURE

internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.

Intervention Group

Brostrom-Gould ankle Ligament reconstruction PROCEDURE

Brostrom-Gould and standard revalidation including 6 weeks immobilisation.

Control Group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter van der Weegen: lead
• Medinova Clinics: collaborator
• Gelre Hospitals: collaborator

Study Sites (3)

Gelre Ziekenhuis

Apeldoorn, Netherlands

RECRUITING

Medinova

Breda, Netherlands

RECRUITING

St Anna hospital

Geldrop, 5664EH, Netherlands

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Sprains and Strains

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Walter van der Weegen, Dr.

  St. Anna Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter van der Weegen, Dr.

CONTACT

+31 (0) 40 2864 280; w.vander.weegen@st-anna.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 21, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)