Surgical Management of Posterior Tibial Plateau Fractures

NCT03540719 | Completed

• 1 other identifier: S60860
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 4

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).

Conditions

Tibial Fractures

Keywords

classification; questionnaires; open reduction; internal fixation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Complications

  1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year

Interventions

Osteosynthesis PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis

You may not qualify if:

• Absent contact information
• living abroad and cannot participate in the follow-up visits
• non-functional leg prior to treatment/injury
• pathological fractures
• bilateral fractures

Sponsors & Collaborators

• Harm Hoekstra, prof. dr.: lead

Study Sites (4)

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Erasmus MC Rotterdam

Rotterdam, 3015, Netherlands

Location

Luzerner Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Harm Hoekstra, Prof. MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Harm Hoekstra

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 30, 2018
• Study Start: May 30, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

BE (2); CH (1); NL (1)