Surgical management of posterior tibial condyle fractures.
Summary description of the study
This clinical study is being conducted at 4 different clinics in Europe. A total of approximately 120 patients will be included. The initiator and organizer of this research is the Department of Traumatology at the University Hospital Leuven (UZ Leuven), Belgium. The Lucerne Cantonal Hospital participates as one of the four centers in the study. The study includes all posterior tibial condyle fractures (tibial condyle or tibial plateau fractures) that require surgical management. Using a classification system, the fractures are categorized prior to surgery and included in the study accordingly. The surgery for the fractures will be performed using a newly developed osteosynthesis plate (Wave Proximal Posterior Tibia Plate, Fa. 7sMedical), which allows optimized management of the posterior tibia, which is generally difficult to address. The aim of this study is to explore the benefits of this repositioning and fixation technique for posterior tibial condyle fractures.
(BASEC)
Intervention under investigation
Management of posterior tibial condyle fractures using a WAVE plate.
(BASEC)
Disease under investigation
Fractures of the posterior tibial condyle. The joint surface of the tibia at the level of the knee joint can be divided into a posterior, an inner, and an outer part. We will focus on a fracture where the posterior tibial condyle is affected.
(BASEC)
- Age over 18 years at the time of the accident - All tibial condyle fractures where the posterior part of the upper tibial joint is affected and require surgical management. (BASEC)
Exclusion criteria
- Severe neurological impairment and restricted movement of the affected leg or non-functional leg already present before the accident. - Fractures without a traumatic event - Fractures in both legs (BASEC)
Trial sites
Luzern
(BASEC)
Sponsor
Dr. Harm Hoekstra (Belgium) PD Dr. med. Björn-Christian Link (Switzerland)
(BASEC)
Contact
Contact Person Switzerland
Björn-Christian Link
0041 41 205 47 48
Bjoern-christian.link@clutterluks.chLuzerner Kantonsspital
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
02.03.2018
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Surgical management of posterior tibial plateau fractures (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available