HTO With and Without Arthroscopy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Fowler Kennedy Sport Medicine Clinic.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Fowler Kennedy Sport Medicine Clinic

ClinicalTrials.gov Identifier:

NCT00284622

First received: January 31, 2006

Last updated: January 28, 2009

Last verified: January 2009

History of Changes

Purpose

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

Condition	Intervention	Phase
Medial Compartment Osteoarthritis of the Knee	Procedure: Arthroscopy	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:

self-reported quality of life (WOMAC). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

self-reported functional ability (LEFS), [ Time Frame: 2 years ] [ Designated as safety issue: No ]
swelling [ Time Frame: 2 years ] [ Designated as safety issue: No ]
pain [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
frequency of analgesic use (patient diary), [ Time Frame: 3 mths ] [ Designated as safety issue: No ]
general health (SF-36). [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]


Estimated Enrollment:	98
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Arthroscopy

HTO with pre-scope

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284622

Contacts


Contact: J.. Robert Giffin, MD, FRCSC	519-661-2111 ext 87505	stdshg@uwo.ca
Contact: Sharon H Griffin, CCS,	519-661-2111 ext 87505	s.griffin@uwo.ca

Locations


Canada, Ontario
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

Sponsors and Collaborators

Fowler Kennedy Sport Medicine Clinic

Investigators


Principal Investigator:	J. Robert Giffin, MD, FRCSC	Fowler Kennedy Sport Medicine Clinic

More Information


Responsible Party:	Robert Giffin, FKSMC
ClinicalTrials.gov Identifier:	NCT00284622 History of Changes
Other Study ID Numbers:	HTO-1
Study First Received:	January 31, 2006
Last Updated:	January 28, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:


HTO Arthroscopy Osteoarthritis Alignement Varus gonarthrosis

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Knee Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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