Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee

NCT ID: NCT00562822

Last Updated: 2014-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.

Detailed Description

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Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arthroscopic Surgery

Arthroscopic surgery optimized with physical and medical therapy

Group Type ACTIVE_COMPARATOR

Arthroscopic surgery

Intervention Type PROCEDURE

Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee

Physical and medical therapy

Intervention Type OTHER

Treatment with physical and medical therapy alone

Physical and medical therapy

treatment with physical and medical therapy alone

Group Type ACTIVE_COMPARATOR

Physical and medical therapy

Intervention Type OTHER

Treatment with physical and medical therapy alone

Interventions

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Arthroscopic surgery

Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee

Intervention Type PROCEDURE

Physical and medical therapy

Treatment with physical and medical therapy alone

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification

Exclusion Criteria

* Patients with inflammatory or post-infectious arthritis
* Those who had undergone previous arthroscopic treatment for knee osteoarthritis
* Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Brian G Feagan, MD

Role: STUDY_CHAIR

Western University, Canada

Locations

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London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.

Reference Type BACKGROUND
PMID: 12110735 (View on PubMed)

Other Identifiers

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MCT-15227

Identifier Type: -

Identifier Source: secondary_id

mrc123456

Identifier Type: -

Identifier Source: org_study_id

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