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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005614
Enrollment
120
Registered
2014-02-17
Start date
2008-12-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M17.3

Interventions

Group 1: Intraoperative Navigation with the OthoPilot system in high tibial osteotomy (TomoFix or Position HTO plate / After-Treatment: 11 days 20 Kg partial weight bearing or 6 weeks 20 Kg partial we

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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?

Countries

Germany

Contacts

Public ContactSteffen Schröter

Berufsgenossenschaftliche Unfallklinik Tübingen

sschroeter@bgu-tuebingen.de07071-6063801

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026