Fixation Stability and Bony Healing Following Open Wedge High Tibial Osteotomy

NCT00284596 | Completed

• 1 other identifier: 10268
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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. 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.
2. 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.

Conditions

Opening Wedge High Tibial Osteotomy

Keywords

Opening wedge high tibial osteotomy; Radio Sterometric Analysis; Locking screw fixation

Outcome Measures

Primary Outcomes (1)

• The primary outcomes are the fixation stability of the implant

  2 years

Secondary Outcomes (1)

• Validated disease specific outcome measures

  2 years

Interventions

High tibial osteotomy PROCEDURE

HTO

Also known as: open wedge

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fowler Kennedy Sport Medicine Clinic: lead

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic, University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Study Officials

• Robert Giffin, MD

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 1, 2006
• Study Start: February 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

CA (1)