Comparing treatment methods for complex ankle fractures
Operative Treatment of Complex Ankle Fractures: Comparison of the Results With and Without Ankle Arthroscopy-a Randomized Controlled Trial
NA · Ludwig-Maximilians - University of Munich · NCT02449096
This study is testing whether using a special camera technique during surgery for complex ankle fractures helps adults recover better than traditional surgery alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich (other) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT02449096 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the outcomes of complex ankle fractures treated with and without the use of ankle arthroscopy. The study aims to determine if supplementary arthroscopic procedures can improve the identification and management of intraarticular injuries, which may lead to better recovery outcomes. Participants will be adults aged 18 to 65 with acute ankle fractures classified under specific AO types. The trial will assess the effectiveness of arthroscopically assisted open reduction and internal fixation compared to traditional open procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with acute ankle fractures classified as AO type 44 A2, A3, B2, B3, C1-C3.
Not a fit: Patients with less severe fractures, open fractures, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced complications for patients with complex ankle fractures.
How similar studies have performed: Previous studies have suggested that arthroscopic techniques can enhance outcomes in similar orthopedic conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 -65 years * Acute ankle fracture (0-14 days) classified as AO type 44 A2, A3, B2, B3, C1-C3 * Written informed consent (patient is able to read and understand German language properly) Exclusion Criteria: * Patients under 18 years or over 65 years * Patients who have acute infections, mental illnesses, high anesthesiological risk (ASA \>3) * Patients with expected incompliance * Pregnant women, prisoners or patients under guardianship * Acute ankle fracture classified as AO type 44 A1 or B1 fracture, pilon or plafond-variant injury * Open fractures * Fractures with radiologically detectable intraarticular lesions * Patients without written informed consent Men and women aged 18-65 years with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1, C2, C3) according to the judgment of the surgeons of the foot and ankle team of our level I trauma center are enrolled in the trial. Each fracture will be evaluated and graded according to classification reported by AO Foundation (figure 1). Patients will be informed about our current investigation by detailed patient information. Only patients, who confirm the operative procedure, will be enrolled. To avoid misclassification, all radiographs will be evaluated by at least two of the three orthopedic surgeons. Disagreements will be resolved by consent. Only patients with a maximum interval of two weeks between injury and intervention must be included. All patients included must be able to understand the meaning of the trial and its consequences. Written informed consent is mandatory for trial inclusion. No additional investigation (clinical or radiographic investigation) will take place if the patient is included compared to patients who refuse inclusion. A list of inclusion and exclusion criteria can be found below. Patients will be excluded in case of open fractures or radiographically identified intraarticular lesions. Also, patients with a high risk of anesthesiology problems (i.e., ASA risk score \> 3), acute infection, mental illness or low expected compliance will be excluded from trial participation. If patients issue a certain treatment preference, they will be excluded as well. Patients, who meet our inclusion criteria or any exclusion criteria, will be informed in detail. After written informed consent, patients will be randomized to one of the two study arms.
Where this trial is running
Munich, Bavaria
- Ludwig Maximilians University, LMU, Munich — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Study coordinator: Mareen Braunstein, M.D.
- Email: Mareen.Braunstein@med.uni-muenchen.de
- Phone: 0049-89-440052511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ankle Fractures