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Position HTO Multicenter NIS (Position HTO)

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ClinicalTrials.gov Identifier: NCT00889304
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : July 22, 2011
Information provided by:
Aesculap AG

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

Condition or disease Intervention/treatment
Medial Monocompartmental Osteoarthritis of the Knee Device: Position HTO system

Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System
Study Start Date : July 2007
Primary Completion Date : August 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Group/Cohort Intervention/treatment
HTO cohort
Device: Position HTO system
open wedge high tibial osteotomy

Primary Outcome Measures :
  1. Patient health status improvement assessed by IKDC 2000 subjective knee score [ Time Frame: 1 year after HTO ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889304

Orthopädie Harthausen
Bad Aibling, Germany, 83043
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany, 97980
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Winghofer Medicum
Rottenburg, Germany, 72108
BGU Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
Aesculap AG
Principal Investigator: Jürgen Fritz, Dr. Winghofer Medicum

Responsible Party: Viktor Breul, Aesculap AG
ClinicalTrials.gov Identifier: NCT00889304     History of Changes
Other Study ID Numbers: AAG-O-H-0702
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Aesculap AG:
HTO, high tibial osteotomy, open wedge, medial arthritis

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases