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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis | Procedure | Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective evaluation: outcome | Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems. | 1 year |
| Subjective evaluation: pain | Visual analogue scale (VAS) to indicate the daily pain level. | 1 year |
| Clinical evaluation | Recording of demographic and fracture-related characteristics. | 1 year |
| Radiographic evaluation | Parameters derived from CT and RX. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis. | 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient at emergency room and clinic of the department of traumatology.
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| Name | Affiliation | Role |
|---|---|---|
| Harm Hoekstra, Prof. MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | 1090 | Belgium | |||
| UZ Leuven |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 15, 2021 | |
| Reset | Nov 12, 2021 | |
| Release | Jan 5, 2022 | |
| Reset | Mar 8, 2022 | |
| Release | Feb 15, 2023 | |
| Reset | Nov 22, 2023 | |
| Release | Dec 6, 2024 | |
| Reset | Jan 17, 2025 | |
| Release | Apr 10, 2025 | |
| Reset | Apr 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2021 | Nov 12, 2021 | |||
| Jan 5, 2022 |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Leuven |
| 3000 |
| Belgium |
| Erasmus MC Rotterdam | Rotterdam | 3015 | Netherlands |
| Luzerner Kantonsspital Luzern | Lucerne | 6000 | Switzerland |
| Mar 8, 2022 |
| Feb 15, 2023 | Nov 22, 2023 |
| Dec 6, 2024 | Jan 17, 2025 |
| Apr 10, 2025 | Apr 29, 2025 |