Perioperative Intervention to Improve Post-TKR Support and Function - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00566826

Purpose

Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.

Condition	Intervention	Phase
Osteoarthritis Arthroplasty, Replacement, Knee	Behavioral: Patient support sessions Behavioral: Treatment as usual	Phase II

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Perioperative Intervention to Improve Post-TKR Support and Function

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patient support treatment sessions	Behavioral: Patient support sessions Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
2: Active Comparator Treatment as usual	Behavioral: Treatment as usual Treatment as usual includes standard care for TKR surgery rehabilitation.

Detailed Description:

Each year, more than 350,000 adults elect to have TKR surgery to eliminate knee pain and associated disabilities that persist despite ample medical treatment. Common knee problems of people who undergo TKR surgery include osteoarthritis, rheumatic diseases, and sudden or gradual joint injury. Most people who undergo TKR surgery experience immediate and significant decrease in pain, improved joint function, and increased physical activity. However, not all people who undergo TKR surgery report improvement, and there is no one factor that contributes to this variation in functional gain. With the rapid growth in the number of people electing to have TKR surgery and in the number of candidates eligible for TKR, optimal surgical results are both a clinical and public health priority. This study will evaluate the effectiveness of a patient support program emphasizing exercise and emotional health in increasing physical function after TKR surgery.

Participants in this study will be randomly assigned to a TKR patient support program or treatment as usual. The intervention patients will receive a program designed to complement the intensive physical rehabilitation period.

Sessions will aim to help participants enhance their self-management skills for behavior change.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry

Exclusion Criteria:

TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
Inability to return home during the rehabilitation period
Co-existing conditions that would negate functional improvement with surgery and exercise
TKR surgery scheduled on an emergency basis
Scheduled for TKR surgeries of both knees at the same time
Terminal illness with a life expectancy of less than 1 year
Inability to provide informed consent due to dementia or cognitive impairment
Planning another TKR or THR surgery within 6 months of study entry
Unavailable to complete study procedures (i.e., will be out of the region during the rehabilitation period)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566826

Contacts

Contact: Janel Milner

508-856-2202

janel.milner@umassmed.edu

Locations

United States, Massachusetts
University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center	Recruiting
Worcester, Massachusetts, United States, 01655
Sub-Investigator: David C. Ayers, MD

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:	Patricia D. Franklin, MD	University of Massachusetts Medical School
Study Director:	Milagros C. Rosal, PhD	University of Massachusetts Medical School

More Information

Responsible Party:	University of Massachusetts Medical School ( Patricia D. Franklin, MD )
Study ID Numbers:	R01 AR054479
Study First Received:	November 30, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00566826
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Physical Function
Total Knee Replacement
Physical Activity
Behavioral Support

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009