Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy
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
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.
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.
|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|
- The primary outcomes are the fixation stability of the implant [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Validated disease specific outcome measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Procedure: High tibial osteotomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284596
|Fowler Kennedy Sport Medicine Clinic, University of Western Ontario|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Robert Giffin, MD||University of Western Ontario, Canada|