Position HTO system
Deviceopen wedge high tibial osteotomy
Completed
NCT Number: NCT00889304
Position HTO Multicenter NIS
Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Orthopädie Harthausen, Bad Aibling, Germany
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
Aesculap AG
Industry
Registry information
Official study title
Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System
Acronym: Position HTO
Important dates
- Study start
- 2007
- Primary completion
- 2009
- Study completion
- 2010
- First posted
- Apr 28, 2009
- Registry last updated
- Jul 22, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.