HTO With and Without Arthroscopy
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|ClinicalTrials.gov Identifier: NCT00284622|
Recruitment Status : Unknown
Verified January 2009 by Fowler Kennedy Sport Medicine Clinic.
Recruitment status was: Not yet recruiting
First Posted : February 1, 2006
Last Update Posted : January 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Medial Compartment Osteoarthritis of the Knee||Procedure: Arthroscopy||Phase 2|
Arthroscopy for degenerative conditions of the knee is among the most widely employed orthopaedic procedures, but its effectiveness (like the effectiveness of many surgical operations) has never been proven in prospective trials. The evidence supporting the use of arthroscopy in treatment algorithms for knee OA comes largely from case series and cohort studies. These studies have shown that about 50% of patients report pain relief following the procedure. Predictors of poor outcome following arthroscopy include marked mal-alignment, restricted range of motion, advanced radiographic changes, and prior surgery. Improved outcomes are predicted by preoperative mechanical symptoms caused by loose bodies, meniscal tears, or radiographic evidence of mild articular degeneration.
The proposed study is a randomized clinical trial.
Each patient will undergo a preoperative MRI of their affected knee joint to identify existing pathology (e.g. meniscal tears, loose bodies, chondral flaps). The results of the MRI will not be revealed to physicians, patients or data collectors. This will ensure that we have information on the existing joint pathology within each group and that prognostic variables between groups were sufficiently balanced (i.e. comparable rates of similar pathology per group). The primary outcome measure is self-reported quality of life (WOMAC). Secondary measures include self-reported functional ability (LEFS), swelling, pain and frequency of analgesic use (patient diary), and general health (SF-36). Assessments will take place preoperatively and at 3, 6 and 12 months postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy With or Without Arthroscopy of the Knee Joint on Quality of Life, Functional Ability and Pain for Patients With Medical Compartment Osteoarthritis of the Knee|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
- self-reported quality of life (WOMAC). [ Time Frame: 2 years ]
- self-reported functional ability (LEFS), [ Time Frame: 2 years ]
- swelling [ Time Frame: 2 years ]
- pain [ Time Frame: 2 yrs ]
- frequency of analgesic use (patient diary), [ Time Frame: 3 mths ]
- general health (SF-36). [ Time Frame: 2 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284622
|Contact: J.. Robert Giffin, MD, FRCSC||519-661-2111 ext firstname.lastname@example.org|
|Contact: Sharon H Griffin, CCS,||519-661-2111 ext email@example.com|
|Fowler Kennedy Sport Medicine Clinic||Not yet recruiting|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator: J.Robert Giffin, MD, FRCSC|
|Sub-Investigator: Dianne Bryant, MSc, PhD|
|Sub-Investigator: Kevin Willits, MD, FRCSC|
|Principal Investigator: Robert B Litchfield, MD. FRCSC|
|Principal Investigator: David Holdsworth, PhD|
|Principal Investigator: Alison Spouge, MD, FRCCP|
|Principal Investigator:||J. Robert Giffin, MD, FRCSC||Fowler Kennedy Sport Medicine Clinic|