Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy

This study has been completed.
Sponsor:
Information provided by:
Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00284596
First received: January 31, 2006
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

Patients undergoing opening wedge high tibial osteotomy (HTO) will be randomized to standard or locking screw fixation of the osteotomy plate. Tantalum beads will be implanted around the osteotomy site in all subjects to facilitate RSA imaging which will then allow micromotion at the osteotomy site to be quantified.

Primary Objectives and Hypothesis

  1. a)to determine fixation stability of the Puddu opening wedge osteotomy plate secured with non-locking compared to locking screws. We hypothesize that plate fixation with locking screws will result in a significant reduction of micromotion between tibial segments prior to bony healing compared to the non-locking screw fixation.

    b)To determine the progress of bony healing. We hypothesize that increased fixation stability in patients with locking screws will facilitate early bone healing reflected by smaller micromotion over time compared to the non-locking screw patients.

  2. a)If there is improved stability with the use of locking screws, rehabilitation protocols following opening wedge HTO will be modified accordingly. We hypothesize that decreasing micromotion will reach the detection limit of the RSA setup (0.4 mm) earlier in the locking screw group than in the non-locking screw group.

    b)To evaluate the effect of the osteotomy on proximal tibial anatomy. We hypothesize that an open-wedge procedure might increase rather than decrease the tibial slope.


Condition Intervention
Opening Wedge High Tibial Osteotomy
Procedure: High tibial osteotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Fixation Stability and Progress of Bony Healing Following Open-Wedge High- Tibial Osteotomy A 24-Subject Clinical Pilot Study Using Radio Stereometric Analysis

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:
  • The primary outcomes are the fixation stability of the implant [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validated disease specific outcome measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: High tibial osteotomy
    HTO
    Other Name: open wedge
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients between the ages of 30 and 70 years of age scheduled for HTO
  • Localized, activity-related knee pain· Varus alignment
  • Medial unicompartmental degenerative osteoarthritis
  • No significant patellofemoral symptoms
  • A ligamentously stable knee
  • Fixed flexion of <5°

Exclusion Criteria:

  • Advanced patellofemoral osteoarthritis
  • Osteoarthritic involvement of the lateral compartment
  • A decreased range of motion less than 90° and a flexion deformity that exceeds 10°
  • Knee ligament instability
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, that would interfere with adherence to study requirements
  • Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy
  • Inability of patient to speak, read or understand English
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284596

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic, University of Western Ontario
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
Investigators
Principal Investigator: Robert Giffin, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Robert Giffin, FKSMC
ClinicalTrials.gov Identifier: NCT00284596     History of Changes
Other Study ID Numbers: 10268
Study First Received: January 31, 2006
Last Updated: January 28, 2009
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Opening wedge high tibial osteotomy
Radio Sterometric Analysis
Locking screw fixation

ClinicalTrials.gov processed this record on September 30, 2014