Position HTO Multicenter NIS (Position HTO)

July 21, 2011 updated by: Aesculap AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Aibling, Germany, 83043
        • Orthopädie Harthausen
      • Bad Mergentheim, Germany, 97980
        • Caritas-Krankenhaus Bad Mergentheim
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Rottenburg, Germany, 72108
        • Winghofer Medicum
      • Tübingen, Germany, 72076
        • BGU Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient health status improvement assessed by IKDC 2000 subjective knee score
Time Frame: 1 year after HTO
1 year after HTO

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year after HTO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Jürgen Fritz, Dr., Winghofer Medicum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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