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

Primary Purpose

Rehabilitation of Surgically Treated Ankle Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Early pain dependent weight-bearing without immobilization
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation of Surgically Treated Ankle Fractures

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Trauma Surgery, Medical University of MunichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early pain dependent weight-bearing without immobilization

Arm Description

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.

Outcomes

Primary Outcome Measures

Complications at 3 months follow-up
Complications, including surgical side infections, secondary dislocation, or thromboembolic events.
Patient-rated outcome at 12 months follow-up
Olerud and Mollander Ankle Score (0-100 points; 100=best score)

Secondary Outcome Measures

Patient-rated outcome at 12 months follow-up
MoXFQ (0-100 metric where 100=most severe)
Patient-rated outcome at 12 months follow-up
EFAS (0-24 points daily activities, 0-16 points sports scale; 0=worst score)
Patient-rated outcome at 12 months follow-up
EQ-5D-5L
Fracture characteristics
Fracture details, including fracture severity (uni-, bi-, Trimalleolar fractures); comminution, dislocation.
Treatment details
Type of osteosynthetic material used, ORIF or AORIF, intra-articular pathologies
Demographics
Age, Sex, BMI

Full Information

First Posted
May 30, 2022
Last Updated
July 1, 2022
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Universitätsklinikum Hamburg-Eppendorf, University Medical Center Rostock, University Hospital Muenster, University Hospital Carl Gustav Carus
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1. Study Identification

Unique Protocol Identification Number
NCT05419154
Brief Title
Full-Weightbearing Following Ankle Fractures Surgically Treated - The FAST-Mobility Trial
Official Title
A Pragmatic, Multi-center, Multi-surgeon Prospective Outcome Study on Immediate Pain-dependent Weight-bearing Without Immobilization After Surgically Treated Ankle Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Universitätsklinikum Hamburg-Eppendorf, University Medical Center Rostock, University Hospital Muenster, University Hospital Carl Gustav Carus

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
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.
Detailed Description
Background Ankle fractures are among the most common fractures in adulthood. Various novel surgical treatment strategies have been developed but nothing has changed regarding the postoperative treatment protocol. Although previous studies indicated that early pain dependent weight-bearing without immobilization in surgically treated ankle fractures is safe, these studies were underpowered. Therefore, the aim of this pragmatic, multi-center, multi-surgeon, prospective outcome 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. Methods The herein proposed study is a pragmatic, multi-center, multi-surgeon, prospective outcome study. Included patients must be independently living and mobile and at least 18 years. Included will be any isolated ankle fracture which was treated surgically without additional syndesmotic stabilization (suture-button or syndesmotic screw). Patients will be recruited following surgical treatment and are advised to conduct pain-dependent full weight-bearing without immobilization starting at the day of study inclusion. The use of crutches is allowed per the individual patients demands. Patients will be invited for follow-up visits at 6 weeks, 3-, 6-, and 12 months. Data assessment at each study point includes radiographic follow-up, complication assessment, return to work/sports, rang of ankle motion, and patient-rated outcome scores (MoxFQ, EFAS, OMAS, EQ-5D-5L). Two primary outcome parameters will be assessed: (1) Complications at 3 months; (2) Patient-rated outcome at 12 months. The sample size calculation revealed a final total sample size of 360 patients. The principle statistical evaluation will be descriptive. For the secondary outcome parameters, a multi-variant regression model will be calculated, individually for complication rates and the patient-rated outcome measures. Discussion Early pain dependent weightbearing bears the chances to increase patient satisfaction, decrease the time of recovery, and improve the overall patient-rated outcome. These chances must we weighted against a possibly increased risk for complications. Still, the limited data available point at a superiority of early pain-dependent weight-bearing. Due to the high patient number, the herein proposed study is the first to provide resilient data capable of changing the current postoperative rehabilitation regime for surgically treated ankle fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation of Surgically Treated Ankle Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pragmatic, multi-center, multi-surgeon, prospective outcome study
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early pain dependent weight-bearing without immobilization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early pain dependent weight-bearing without immobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complications at 3 months follow-up
Description
Complications, including surgical side infections, secondary dislocation, or thromboembolic events.
Time Frame
3 months +/- 14 Days
Title
Patient-rated outcome at 12 months follow-up
Description
Olerud and Mollander Ankle Score (0-100 points; 100=best score)
Time Frame
12 months +/- 30 days
Secondary Outcome Measure Information:
Title
Patient-rated outcome at 12 months follow-up
Description
MoXFQ (0-100 metric where 100=most severe)
Time Frame
12 months follow-up
Title
Patient-rated outcome at 12 months follow-up
Description
EFAS (0-24 points daily activities, 0-16 points sports scale; 0=worst score)
Time Frame
12 months follow-up
Title
Patient-rated outcome at 12 months follow-up
Description
EQ-5D-5L
Time Frame
12 months follow-up
Title
Fracture characteristics
Description
Fracture details, including fracture severity (uni-, bi-, Trimalleolar fractures); comminution, dislocation.
Time Frame
3- and 12 months follow-up
Title
Treatment details
Description
Type of osteosynthetic material used, ORIF or AORIF, intra-articular pathologies
Time Frame
3- and 12 months follow-up
Title
Demographics
Description
Age, Sex, BMI
Time Frame
3- and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian F Baumbach, MD
Phone
0049894400519474
Email
sebastian.baumbach@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Polzer, MD
Phone
0049894400511233
Email
hans.polzer@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian F Baumbach, MD
Organizational Affiliation
LMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Trauma Surgery, Medical University of Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian F. Baumbach, M.D.
Email
sebastian.baumbach@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Sebastian F. Baumbach, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Patient data will be shared if requested with reasonable arguments.

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

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