Surgical Management of Posterior Tibial Plateau Fractures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03540719

Acronym

Proxtib

Enrollment

Registered

2018-05-30

Start date

2018-05-30

Completion date

2020-10-30

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Fractures

Keywords

classification, questionnaires, open reduction, internal fixation

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).

Interventions

PROCEDUREOsteosynthesis

Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
Radiographic evaluation	1 year	Parameters derived from CT and RX.

Secondary

Measure	Time frame	Description
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.

Countries

Belgium, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026