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Completed

NCT Number: NCT03540719

Surgical Management of Posterior Tibial Plateau Fractures

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteosynthesis

Procedure

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

Primary outcomes

  1. Subjective evaluation: outcome

    Time frame: 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.

  2. Subjective evaluation: pain

    Time frame: 1 year

    Visual analogue scale (VAS) to indicate the daily pain level.

  3. Clinical evaluation

    Time frame: 1 year

    Recording of demographic and fracture-related characteristics.

  4. Radiographic evaluation

    Time frame: 1 year

    Parameters derived from CT and RX.

Secondary outcomes

  1. Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harm Hoekstra, prof. dr.

Other

Registry information

Acronym: Proxtib

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 30, 2018
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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