Surgical Management of Posterior Tibial Plateau Fractures

Tibial Fractures Clinical Trial

— Proxtib  

Official title:

Surgical Management of Posterior Tibial Plateau Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540719
• Other study ID #: S60860
• Status: Completed
• Start date: May 30, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• Osteosynthesis
Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Belgium	UZ Leuven	Leuven
Netherlands	Erasmus MC Rotterdam	Rotterdam
Switzerland	Luzerner Kantonsspital Luzern	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Harm Hoekstra, prof. dr.

Countries where clinical trial is conducted

Belgium,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Subjective evaluation: pain	Visual analogue scale (VAS) to indicate the daily pain level.	1 year
Primary	Clinical evaluation	Recording of demographic and fracture-related characteristics.	1 year
Primary	Radiographic evaluation	Parameters derived from CT and RX.	1 year
Secondary	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