HTO With and Without Arthroscopy
Primary Purpose
Medial Compartment Osteoarthritis of the Knee
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Arthroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Medial Compartment Osteoarthritis of the Knee focused on measuring HTO, Arthroscopy, Osteoarthritis, Alignement, Varus gonarthrosis
Eligibility Criteria
Inclusion Criteria: patients with medial compartment osteoarthritis as determined by clinical examination and plain radiographs. scheduled for an HTO Exclusion Criteria: 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
Sites / Locations
- Fowler Kennedy Sport Medicine Clinic
Outcomes
Primary Outcome Measures
self-reported quality of life (WOMAC).
Secondary Outcome Measures
self-reported functional ability (LEFS),
swelling
pain
frequency of analgesic use (patient diary),
general health (SF-36).
Full Information
NCT ID
NCT00284622
First Posted
January 31, 2006
Last Updated
January 28, 2009
Sponsor
Fowler Kennedy Sport Medicine Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00284622
Brief Title
HTO With and Without Arthroscopy
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fowler Kennedy Sport Medicine Clinic
4. Oversight
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Compartment Osteoarthritis of the Knee
Keywords
HTO, Arthroscopy, Osteoarthritis, Alignement, Varus gonarthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy
Intervention Description
HTO with pre-scope
Primary Outcome Measure Information:
Title
self-reported quality of life (WOMAC).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
self-reported functional ability (LEFS),
Time Frame
2 years
Title
swelling
Time Frame
2 years
Title
pain
Time Frame
2 yrs
Title
frequency of analgesic use (patient diary),
Time Frame
3 mths
Title
general health (SF-36).
Time Frame
2 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with medial compartment osteoarthritis as determined by clinical examination and plain radiographs.
scheduled for an HTO
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J.. Robert Giffin, MD, FRCSC
Phone
519-661-2111
Ext
87505
Email
stdshg@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon H Griffin, CCS,
Phone
519-661-2111
Ext
87505
Email
s.griffin@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Robert Giffin, MD, FRCSC
Organizational Affiliation
Fowler Kennedy Sport Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.Robert Giffin, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Kevin Willits, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Robert B Litchfield, MD. FRCSC
First Name & Middle Initial & Last Name & Degree
David Holdsworth, PhD
First Name & Middle Initial & Last Name & Degree
Alison Spouge, MD, FRCCP
12. IPD Sharing Statement
Learn more about this trial
HTO With and Without Arthroscopy
We'll reach out to this number within 24 hrs