Position HTO Multicenter NIS

Aesculap AG221 enrolled

Overview

Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy

Study Type

OBSERVATIONAL

Enrollment

221

Conditions

Medial Monocompartmental Osteoarthritis of the Knee

Interventions

Position HTO systemDEVICE

open wedge high tibial osteotomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K\&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K\&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension; Exclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations

Locations (5)

Orthopädie Harthausen

Bad Aibling, Germany

Caritas-Krankenhaus Bad Mergentheim

Bad Mergentheim, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Winghofer Medicum

Rottenburg, Germany

Outcomes

Primary Outcomes

Patient health status improvement assessed by IKDC 2000 subjective knee score

Time frame: 1 year after HTO

Secondary Outcomes

Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS)

Time frame: 1 year after HTO

Data from ClinicalTrials.gov

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