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

Study Overview
=================
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.

Official Title
-----------------
A Pragmatic, Multi-center, Multi-surgeon Prospective Outcome Study on Immediate Pain-dependent Weight-bearing Without Immobilization After Surgically Treated Ankle Fractures

Conditions
-----------------
Rehabilitation of Surgically Treated Ankle Fractures

Intervention / Treatment
-----------------
* Procedure: Early pain dependent weight-bearing without immobilization


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pragmatic, multi-center, multi-surgeon, prospective outcome study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early pain dependent weight-bearing without immobilization<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated outcome at 12 months follow-up | MoXFQ (0-100 metric where 100=most severe) | 12 months follow-up | 
| Patient-rated outcome at 12 months follow-up | EFAS (0-24 points daily activities, 0-16 points sports scale; 0=worst score) | 12 months follow-up | 
| Patient-rated outcome at 12 months follow-up | EQ-5D-5L | 12 months follow-up | 
| Fracture characteristics | Fracture details, including fracture severity (uni-, bi-, Trimalleolar fractures); comminution, dislocation. | 3- and 12 months follow-up | 
| Treatment details | Type of osteosynthetic material used, ORIF or AORIF, intra-articular pathologies | 3- and 12 months follow-up | 
| Demographics | Age, Sex, BMI | 3- and 12 months follow-up |