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inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG

NCT03472404 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-06-05

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • Medinova Clinics

    collaborator UNKNOWN

  • Gelre Hospitals

    collaborator OTHER

  • Walter van der Weegen

    lead OTHER

Principal Investigators

  • Walter van der Weegen, Dr. · St. Anna Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472404 on ClinicalTrials.gov