Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prediction of Outcomes Following Total Knee Replacement (POKR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01370421
First received: June 2, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Outcomes Following Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A widely-used measure of pain severity and pain interference


Biospecimen Retention:   Samples With DNA

saliva and blood


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Knee OA patients undergoing Total Knee Arthroplasty (TKA)
Participants will be 50 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery.

Detailed Description:

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. The research takes place at the Brigham & Women's Pain Management Center, 850 Boylston St, Chestnut Hill. For further information, please contact George (gmensing@partners.org, 617-732-9463).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  • Patients taking anti-inflammatory medications or acetaminophen must be on a stable dose 1 month prior to study.

Exclusion Criteria:

  • Cognitive impairment preventing completion of study assessment procedures
  • Myocardial infarction within the past 12 months
  • Raynaud's phenomenon 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
  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: NCT01370421

Contacts
Contact: Robert Edwards, Ph.D. 617-732-9486 RREdwards@Partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: George Mensing, BA    617-732-9463 ext 29463    gmensing@partners.org   
Contact: Chrissie Cahalan, BS    617-732-9014 ext 29014    ccahalan1@partners.org   
Principal Investigator: Robert R. Edwards, PhD         
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert Edwards, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01370421     History of Changes
Other Study ID Numbers: 2010p000978
Study First Received: June 2, 2011
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014