Surgical Management of Posterior Tibial Plateau Fractures

Completed

• Conditions: Tibial Fractures

• Registration Number: NCT03540719
• Lead Sponsor: Harm Hoekstra, prof. dr.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-16
• Study Start: 2018-05-30
• Study First Posted: 2018-05-30
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic evaluation	1 year	Parameters derived from CT and RX.
Subjective evaluation: outcome	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	1 year	Visual analogue scale (VAS) to indicate the daily pain level.
Clinical evaluation	1 year	Recording of demographic and fracture-related characteristics.

Secondary Outcome Measures

Name	Time	Method
Complications	1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year	Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis.

Trial Locations

Locations (4)

Luzerner Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

UZ Leuven; 🇧🇪 Leuven, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

Erasmus MC Rotterdam; 🇳🇱 Rotterdam, Netherlands