Surgical Management of Posterior Tibial Plateau Fractures (Proxtib)

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).

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Procedure: Osteosynthesis

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Leuven, Belgium, 3000
    • UZ Leuven
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus MC Rotterdam
• Switzerland
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital Luzern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatient at emergency room and clinic of the department of traumatology.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Harm Hoekstra, prof. dr.
• Investigators: Principal Investigator: Harm Hoekstra, Prof. MD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: classification; questionnaires; internal fixation; open reduction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: S60860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No