Status:
COMPLETED
Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy
Lead Sponsor:
Fowler Kennedy Sport Medicine Clinic
Conditions:
Opening Wedge High Tibial Osteotomy
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief 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 sit...
Detailed Description
For this pilot study, a total of 24 patients scheduled for opening wedge HTO who meet the inclusion criteria, have read the study letter of information and signed the informed consent will be randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00284596
Start Date
February 1 2005
End Date
July 1 2007
Last Update
January 29 2009
Active Locations (1)
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1
Fowler Kennedy Sport Medicine Clinic, University of Western Ontario
London, Ontario, Canada, N6A 3K7