HTO With and Without Arthroscopy
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
1 other identifier
interventional
98
1 country
1
Brief Summary
It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits of surgery (quality of life and functional ability) for young active patients with medial compartment OA of the knee and varus alignmen. This additional procedure has a low incidence of morbidity and would potentially allow for treatment of meniscal tears and articular damage, as well as joint lavage to remove debris and inflammatory factors. A trial is needed to determine whether HTO with concomitant knee arthroscopy will result in better overall outcomes for this patient group.The objective is to compare the quality of life, functional status, pain, and swelling of patients who undergo an HTO with or without a concomitant knee joint arthroscopy to address additional joint pathology
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 29, 2009
January 1, 2009
2 years
January 31, 2006
January 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
self-reported quality of life (WOMAC).
2 years
Secondary Outcomes (5)
self-reported functional ability (LEFS),
2 years
swelling
2 years
pain
2 yrs
frequency of analgesic use (patient diary),
3 mths
general health (SF-36).
2 yrs
Interventions
HTO with pre-scope
Eligibility Criteria
You may qualify if:
- patients with medial compartment osteoarthritis as determined by clinical examination and plain radiographs.
- scheduled for an HTO
You may not qualify if:
- Evidence of other significant knee pathology,
- Active joint or systemic infection,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand the English language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Robert Giffin, MD, FRCSC
Fowler Kennedy Sport Medicine Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 1, 2006
Study Start
December 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 29, 2009
Record last verified: 2009-01