Perioperative Intervention to Improve Post-TKR Support and Function
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Perioperative Intervention to Improve Post-TKR Support and Function |
- Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
- Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
| Enrollment: | 196 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 |
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| United States, Massachusetts | |
| University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center | |
| Worcester, Massachusetts, United States, 01655 | |
| Principal Investigator: | Patricia D. Franklin, MD | University of Massachusetts, Worcester |
| Study Director: | Milagros C. Rosal, PhD | University of Massachusetts, Worcester |
More Information
No publications provided by University of Massachusetts, Worcester
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Patricia Franklin, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT00566826 History of Changes |
| Other Study ID Numbers: | R01 AR054479, R01AR054479, H 12601 |
| Study First Received: | November 30, 2007 |
| Last Updated: | February 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Massachusetts, Worcester:
|
Physical Function Total Knee Replacement Physical Activity Behavioral Support |
Arthroplasty Function Self-Care |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013