Rehabilitation of Surgically Treated Ankle FracturesNCT05419154
Full-Weightbearing Following Ankle Fractures Surgically Treated - The FAST-Mobility Trial
A study testing Early pain dependent weight-bearing without immobilization in people with Rehabilitation of Surgically Treated Ankle Fractures, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rehabilitation of Surgically Treated Ankle Fractures
- What is being tested?
- Early pain dependent weight-bearing without immobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Trauma Surgery, Medical University of Munich
Munich, 80336
Sebastian F. Baumbach, M.D., sebastian.baumbach@med.uni-muenchen.de
Sebastian F. Baumbach, M.D.
About this study
Official title: A Pragmatic, Multi-center, Multi-surgeon Prospective Outcome Study on Immediate Pain-dependent Weight-bearing Without Immobilization After Surgically Treated Ankle Fractures
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.
Read the 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.
- Being tested
- Early pain dependent weight-bearing without immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early pain dependent weight-bearing without immobilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early pain dependent weight-bearing without immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications at 3 months follow-up
Complications, including surgical side infections, secondary dislocation, or thromboembolic events.
Measured: 3 months +/- 14 Days
Patient-rated outcome at 12 months follow-up
Olerud and Mollander Ankle Score (0-100 points; 100=best score)
Measured: 12 months +/- 30 days
Secondary outcomes (6)
Patient-rated outcome at 12 months follow-up
MoXFQ (0-100 metric where 100=most severe)
Measured: 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)
Measured: 12 months follow-up
Patient-rated outcome at 12 months follow-up
EQ-5D-5L
Measured: 12 months follow-up
Fracture characteristics
Fracture details, including fracture severity (uni-, bi-, Trimalleolar fractures); comminution, dislocation.
Measured: 3- and 12 months follow-up
Treatment details
Type of osteosynthetic material used, ORIF or AORIF, intra-articular pathologies
Measured: 3- and 12 months follow-up
Demographics
Age, Sex, BMI
Measured: 3- and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start30 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation of Surgically Treated Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pragmatic, multi-center, multi-surgeon, prospective outcome study
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Medical Center Rostock, University Hospital Muenster, University Hospital Carl Gustav Carus
- Responsible party
- Principal investigator, Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
- Investigators
- Sebastian F Baumbach, MD, Principal investigator, LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419154
- Sponsor's protocol ID
- Weightbearing Ankle Fracture
- Status last verified
- Jul 2022
- First submitted
- 30 May 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data will be shared if requested with reasonable arguments.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Multi-center, Multi-surgeon Prospective Outcome Study on Immediate Pain-dependent Weight-bearing Without Immobilization After Surgically Treated Ankle Fractures
- ClinicalTrials.gov ID
- NCT05419154
- Acronym / sponsor ID
- Weightbearing Ankle Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Medical Center Rostock, University Hospital Muenster, University Hospital Carl Gustav Carus
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pragmatic, multi-center, multi-surgeon, prospective outcome study
| Arm | Type | Receives |
|---|---|---|
| Early pain dependent weight-bearing without immobilization | Experimental | Procedure: Early pain dependent weight-bearing without immobilizationPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged above 18 years Independently living and mobile
- Unimalleolar fracture: Radiographs in two planes or unilateral CT
- Bi-/Trimalleolar fracture: Unilateral CT Isolated ankle fracture (uni-/ bi-/ trimalleolar fracture)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early pain dependent weight-bearing without immobilizationPatients 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 or surgery | Early pain dependent weight-bearing without immobilization |
Primary outcome
Complications at 3 months follow-up
Time frame: 3 months +/- 14 Days
Complications, including surgical side infections, secondary dislocation, or thromboembolic events.
Patient-rated outcome at 12 months follow-up
Time frame: 12 months +/- 30 days
Olerud and Mollander Ankle Score (0-100 points; 100=best score)
6 secondary outcomes
Patient-rated outcome at 12 months follow-up
Time frame: 12 months follow-up
Patient-rated outcome at 12 months follow-up
Time frame: 12 months follow-up
Patient-rated outcome at 12 months follow-up
Time frame: 12 months follow-up
Fracture characteristics
Time frame: 3- and 12 months follow-up
Treatment details
Time frame: 3- and 12 months follow-up
Demographics
Time frame: 3- and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided. Patient data will be shared if requested with reasonable arguments.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian F Baumbach, MD principal investigator
LMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early pain dependent weight-bearing without immobilization in people with Rehabilitation of Surgically Treated Ankle Fractures, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian F Baumbach, MD (0049894400519474, sebastian.baumbach@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications at 3 months follow-up (time frame: 3 months +/- 14 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.