Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle Arthroscopy
Ankle Fractures
About this trial
This is an interventional treatment trial for Ankle Fractures
Eligibility 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.
Sites / Locations
- Ludwig Maximilians University, LMU, MunichRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Active Comparator
ORIF group
AORIF group
No arthroscope ORIF = Open reduction and internal fixation All Patients will be operated following a standardized protocol of our foot and ankle department: Posterior malleolus: ORIF of the posterior malleolus fractures will be performed using a one-third tubular plate in an antiglide-technique. Lateral malleolus: If the patients suffer a fracture of the posterior and lateral malleolus, a posterolateral approach will be performed. After posterior fracture fixation a lag screw and a one-third tubular plate will be used laterally. In special cases a locking plate will be used. If the patient only suffers a lateral malleolus fracture, we utilize the standard lateral incision. Medial malleolus: We perform a curved incision and two cannulated leg screws/tension wiring or locking plate for fixation. Syndesmotic complex: After all, the stability of the syndesmotic complex is tested and reduction will be performed if necessary.
Arthroscope AORIF = Arthroscopically assisted open reduction and internal fixation Our standard operative protocol is described above. Intervention: In case of randomization to the AORIF group, the arthroscopic procedure will be performed as the first step during the surgery before internal fixation. No distraction device will be used for the ankle. To avoid lesions of the cartilage and soft tissue, the joint will first be inflated with saline, and the portals will be created by blunt dissection. A 2.7mm, 30° arthroscope will be inserted into the ankle through a standard anteromedial portal. Fluid will be aspirated and the cavity filled with water. Afterwards the standard anterolateral portal will be performed in the same way. A standardized systematic examination as described by Ferkel and Fasulo will be performed to inspect the internal structures. At this stage loose bodies and disrupted ligaments extending into the joint will be removed.