Surgical Management of Posterior Tibial Plateau Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tibial Fractures
- Sponsor
- Harm Hoekstra, prof. dr.
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Radiographic evaluation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).
Investigators
Harm Hoekstra, prof. dr.
Prof. Dr. Harm Hoekstra
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
Inclusion Criteria
- •Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis
Exclusion Criteria
- •Absent contact information
- •living abroad and cannot participate in the follow-up visits
- •non-functional leg prior to treatment/injury
- •pathological fractures
- •bilateral fractures
Outcomes
Primary Outcomes
Radiographic evaluation
Time Frame: 1 year
Parameters derived from CT and RX.
Subjective evaluation: outcome
Time Frame: 1 year
Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems.
Subjective evaluation: pain
Time Frame: 1 year
Visual analogue scale (VAS) to indicate the daily pain level.
Clinical evaluation
Time Frame: 1 year
Recording of demographic and fracture-related characteristics.
Secondary Outcomes
- Complications(1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year)