Full-Weightbearing Following Ankle Fractures Surgically Treated - The FAST-Mobility Trial

Summary

The aim of this study is to investigate complication rates and clinical outcome following mobilization and pain-dependent full weight-bearing in a large cohort of patients with surgically treated ankle fractures.

The study design is a pragmatic, multi-center, multi-surgeon, prospective outcome study. Included will be adult patients with any isolated ankle fracture which was treated surgically without additional syndesmotic stabilization (suture-button or syndesmotic screw). Patients included are advised to conduct pain-dependent full weight-bearing without immobilization starting at the day of study inclusion. Follow-up points are 6 weeks, 3-, 6-, and 12 months. Data assessment include radiographic follow-up, complication assessment, return to work/sports, rang of ankle motion, and patient-rated outcome scores (MoxFQ, EFAS, OMAS, EQ-5D-5L). The primary outcomes are complications at 3 months and patient-rated outcome at 12 months. The sample size calculation revealed a final total sample size of 360 patients.

Conditions

• Rehabilitation of Surgically Treated Ankle Fractures

Interventions

PROCEDURE

Early pain dependent weight-bearing without immobilization

Patients are advised to conduct pain-dependent full weight-bearing starting at the day of study inclusion. In case of severe swelling, a splint or below knee cast can be applied until the initial swelling subsides, but no longer than 14 days. Otherwise, no immobilization is applied. The use of crutches is allowed per the individual patients demands. The physiotherapists at the individual study centers are informed prior to study initiation and are briefed about each patient enrolled in the study. Each patient is handed an information sheet for their outpatient physiotherapist.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Medical Center Rostock

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  lead OTHER

Principal Investigators

• Sebastian F Baumbach, MD · LMU

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-30

Primary Completion

2023-12-31

Completion

2024-05-01

Countries

• Germany

Study Locations