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Surgical Management of Posterior Tibial Plateau Fractures

NCT ID: NCT03540719

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-30

Study Completion Date

2020-10-30

Brief Summary

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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).

Detailed Description

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Conditions

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Tibial Fractures

Keywords

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classification questionnaires open reduction internal fixation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Osteosynthesis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harm Hoekstra, prof. dr.

OTHER

Sponsor Role lead

Responsible Party

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Harm Hoekstra, prof. dr.

Prof. Dr. Harm Hoekstra

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Harm Hoekstra, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Brussel

Brussels, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Erasmus MC Rotterdam

Rotterdam, , Netherlands

Site Status

Luzerner Kantonsspital Luzern

Lucerne, , Switzerland

Site Status

Countries

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Belgium Netherlands Switzerland

Other Identifiers

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S60860

Identifier Type: -

Identifier Source: org_study_id