Perioperative Intervention to Improve Post-TKR Support and Function

Osteoarthritis Clinical Trial

Official title:

Perioperative Intervention to Improve Post-TKR Support and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566826
• Other study ID #: R01AR054479
• Secondary ID: R01AR054479H 126
• Status: Completed
• Phase: Phase 2
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis

Intervention

Behavioral:
• Patient support sessions
Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
• Treatment as usual
Treatment as usual includes standard care for TKR surgery rehabilitation.

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center	Worcester	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbi — View Citation

Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/hu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function (SF36, WOMAC)		Measured at Months 6 and 12
Secondary	Physical activity and exercise		Measured at Months 6 and 12