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

NCT05419154 | Unknown

• 1 other identifier: Weightbearing Ankle Fracture
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Complications at 3 months follow-up

  Complications, including surgical side infections, secondary dislocation, or thromboembolic events.

  3 months +/- 14 Days

• Patient-rated outcome at 12 months follow-up

  Olerud and Mollander Ankle Score (0-100 points; 100=best score)

  12 months +/- 30 days

Secondary Outcomes (6)

• Patient-rated outcome at 12 months follow-up

  12 months follow-up

• Patient-rated outcome at 12 months follow-up

  12 months follow-up

• Patient-rated outcome at 12 months follow-up

  12 months follow-up

• Fracture characteristics

  3- and 12 months follow-up

• Treatment details

  3- and 12 months follow-up

Study Arms (1)

Early pain dependent weight-bearing without immobilization

EXPERIMENTAL

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.

Procedure: Early pain dependent weight-bearing without immobilization

Interventions

Early pain dependent weight-bearing without immobilization PROCEDURE

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.

Early pain dependent weight-bearing without immobilization

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged above 18 years Independently living and mobile
• Preoperative imaging:
• Unimalleolar fracture: Radiographs in two planes or unilateral CT
• Bi-/Trimalleolar fracture: Unilateral CT Isolated ankle fracture (uni-/ bi-/ trimalleolar fracture)
• Surgical treatment:
• Posterior malleolus: Undisplaced fracture: Treatment according to the surgeon's preference; Displaced (≥2mm) fragment of sufficient size (approximately ≥10% of the lateral distal tibia): Open reduction and internal fixation using screw(s) and / or plate(s); Displaced (≥2mm), small fragment (approximately \<10% of the lateral distal tibia): Treatment according to the surgeon's preference.
• Lateral malleolus: Open reduction and internal fixation by plate ± compression screw(s).
• Medial malleolus: Closed or open reduction and internal fixation by screw(s) and / or plate(s) osteosynthesis.
• Bony avulsions of the AiTFL (Wagstaffe-Fragment / Tubercule des Chaput): Treatment according to the surgeon's preference.
• Lesions to the Deltoid ligament: Treatment according to the surgeon's preference.
• Arthroscopic assisted fracture treatment: Decision up to the individual surgeon
• Postoperative imaging:
• Unimalleolar fracture: Radiographs in two planes or unilateral CT
• Bi-/Trimalleolar fracture: Uni- or bilateral CT Capable of reading and completing the study consent

You may not qualify if:

• Age under 18 Surgical stabilization of the distal tibio-fibular joint by syndesmotic screw or dynamic stabilization Concomitant injuries, Charcot neuroarthropathy, pre-existing arthritis, deformity
• Tibial pilon fractures, Non-operative treatment
• Inability to provide consent, or declining participation

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Medical Center Rostock: collaborator
• University Hospital Muenster: collaborator
• University Hospital Carl Gustav Carus: collaborator

Study Sites (1)

Department of Trauma Surgery, Medical University of Munich

Munich, 80336, Germany

RECRUITING

MeSH Terms

Interventions

Immobilization

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sebastian F Baumbach, MD

  LMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian F Baumbach, MD

CONTACT

0049894400519474; sebastian.baumbach@med.uni-muenchen.de

Hans Polzer, MD

CONTACT

0049894400511233; hans.polzer@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Foot and Ankle Department, Assistant Professor

Model Details: pragmatic, multi-center, multi-surgeon, prospective outcome study

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 15, 2022
• Study Start: May 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

DE (1)