Text Size

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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013