Prediction of Outcomes Following Total Knee Replacement

NCT ID: NCT01370421

Last Updated: 2022-03-02

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

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2019-03-31

Brief Summary

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This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Detailed Description

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This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. The last visit will be about 1 year after surgery. You may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee OA patients undergoing Total Knee Arthroplasty (TKA)

Participants will be 45 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 50 or older
* Meet the American College of Rheumatology criteria for knee osteoarthritis
* Scheduled to undergo total knee arthroplasty
* Facility with the English language that is adequate to complete study procedures

Exclusion Criteria

* Cognitive impairment preventing completion of study assessment procedures
* Myocardial infarction within the past 12 months
* Severe raynaud's or severe neuropathy
* Active vasculitis or severe peripheral vascular disease
* Current infection
* Use of oral steroids
* Recent history of substance abuse or dependence
* Confirmed diagnosis of periodic limb movement disorder or restless legs syndrome
* Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc.
* Known anemia
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert Edwards

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert R Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2010p000978

Identifier Type: -

Identifier Source: org_study_id

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