NCT00562822

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

8.6 years

First QC Date

November 20, 2007

Last Update Submit

May 21, 2014

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores

    2 years

Secondary Outcomes (1)

  • Health utility using the Standard Gamble Technique

    24 months

Study Arms (2)

Arthroscopic Surgery

ACTIVE COMPARATOR

Arthroscopic surgery optimized with physical and medical therapy

Procedure: Arthroscopic surgeryOther: Physical and medical therapy

Physical and medical therapy

ACTIVE COMPARATOR

treatment with physical and medical therapy alone

Other: Physical and medical therapy

Interventions

Arthroscopic surgeryPROCEDURE

Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee

Arthroscopic Surgery
Physical and medical therapyOTHER

Treatment with physical and medical therapy alone

Arthroscopic SurgeryPhysical and medical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 12110735BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ArthroscopyRestraint, Physical

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic ProceduresBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Peter J Fowler, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

  • Brian G Feagan, MD

    Western University, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 22, 2007

Study Start

January 1, 1999

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

CA(1)