Prediction of Outcomes Following Total Knee Replacement

NCT01370421 | Completed

• 1 other identifier: 2010p000978
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI)

  A widely-used measure of pain severity and pain interference. Pain severity and pain interference scores range from 0-10 (0= no pain / no pain interference and 10= severe pain / pain interference).

  6 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  A widely-used, OA-specific measure of pain, function, and stiffness. WOMAC Pain scores range from 0-50, with 0= no pain and 50= severe pain.

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants for this study will be recruited via flyers posted in hospital clinics, on electronic announcement boards and various other media mediums. Potential subjects will be informed about the study purpose and procedures when they call, and interested subjects will then go through a telephone screening.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva and blood

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Robert R Edwards, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 10, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)