OrthoPilot® navigation of high tibial open wedge osteotomy with TomoFix™ plate and POSITION HTO plate. Prospective and randomized clinical trial.

Not Applicable

• Conditions: M17.3; Other post-traumatic gonarthrosis

• Registration Number: DRKS00005614
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-08-11
• Study Start: 2014-02-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•symptomatic varus deformity
•No osteoporosis
•No joint infection in history
•No malignant disease
•> 18 years
•Written consent of the study participant
•arthroscopic evaluated knee joint situation
•Preoperative planning with MediCAD
•Navigation only with OrthoPilot
• Usage of the TomoFix or Position HTO plate
• Operation technique as showed by Staubli et al.

Exclusion Criteria

•No consent of the study participant
•No preoperative planning available
•For clinical results: No implant removal so far

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is there a difference between the differences planned mTFA (mechanical tibiofemoral angle) and mTFA at 18 months follow-up comparing the groups navigation” and non-navigation”?

Secondary Outcome Measures

Name	Time	Method
Is there a difference in the clinical outcome (measured with different scores: Lysholm score, HSS, Lequesne, IKDC, SF-36, Tegner score, Oxford score) comparing the groups navigation vs. non-navigation, implants (TomoFix vs. POSITION HTO), aftercare (11 days PWB vs. 6 weeks PWB), surgeon (experienced vs. non-experienced) at different points of follow-up (6 months, 12 months, 18 months)? Is there a difference in the incapacity of work comparing the groups with 11 days PWB and 6 weeks PWB, measured while the 18 months follow-up?