Position HTO Multicenter NIS

Medial Monocompartmental Osteoarthritis of the Knee Clinical Trial

— Position HTO  

Official title:

Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889304
• Other study ID #: AAG-O-H-0702
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: July 21, 2011
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medial Monocompartmental Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Position HTO system
open wedge high tibial osteotomy

Locations

Country	Name	City	State
Germany	Orthopädie Harthausen	Bad Aibling
Germany	Caritas-Krankenhaus Bad Mergentheim	Bad Mergentheim
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Winghofer Medicum	Rottenburg
Germany	BGU Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient health status improvement assessed by IKDC 2000 subjective knee score		1 year after HTO	No
Secondary	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)		1 year after HTO	No