Perioperative Intervention to Improve Post-TKR Support and Function

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Completed

CT.gov ID

NCT00566826

Collaborator

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

196

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Osteoarthritis Arthroplasty, Replacement, Knee	Behavioral: Patient support sessions Behavioral: Treatment as usual	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Perioperative Intervention to Improve Post-TKR Support and Function

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Patient support treatment sessions

Behavioral: Patient support sessions

Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.

Active Comparator: 2

Treatment as usual

Behavioral: Treatment as usual

Treatment as usual includes standard care for TKR surgery rehabilitation.

Outcome Measures

Primary Outcome Measures

Physical function (SF36, WOMAC) [Measured at Months 6 and 12]

Secondary Outcome Measures

Physical activity and exercise [Measured at Months 6 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center	Worcester	Massachusetts	United States	01655

Sponsors and Collaborators

University of Massachusetts, Worcester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

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