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Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy

NCT00284596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Opening Wedge High Tibial Osteotomy

Interventions

PROCEDURE

High tibial osteotomy

HTO

Sponsors & Collaborators

  • Fowler Kennedy Sport Medicine Clinic

    lead OTHER

Principal Investigators

  • Robert Giffin, MD · The University of Western Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00284596 on ClinicalTrials.gov