Position HTO Multicenter NIS

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00889304
First received: April 27, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention
Medial Monocompartmental Osteoarthritis of the Knee
Device: Position HTO system

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Patient health status improvement assessed by IKDC 2000 subjective knee score [ Time Frame: 1 year after HTO ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
HTO cohort
Device: Position HTO system
open wedge high tibial osteotomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889304

Locations
Germany
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
Investigators
Principal Investigator: Jürgen Fritz, Dr. Winghofer Medicum
  More Information

No publications provided

Responsible Party: Viktor Breul, Aesculap AG
ClinicalTrials.gov Identifier: NCT00889304     History of Changes
Other Study ID Numbers: AAG-O-H-0702
Study First Received: April 27, 2009
Last Updated: July 21, 2011
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 16, 2014