Perioperative Intervention to Improve Post-TKR Support and Function

Phase 2

Completed

• Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis
• Interventions: Behavioral: Patient support sessions; Behavioral: Treatment as usual

• Registration Number: NCT00566826
• Lead Sponsor: University of Massachusetts, Worcester

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.

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 Timeline

• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-04
• Study Start: 2008-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Patient support sessions	Patient support treatment sessions
2	Treatment as usual	Treatment as usual

Primary Outcome Measures

Name	Time	Method
Physical function (SF36, WOMAC)	Measured at Months 6 and 12

Secondary Outcome Measures

Name	Time	Method
Physical activity and exercise	Measured at Months 6 and 12

Trial Locations

Locations (1)

University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center; 🇺🇸 Worcester, Massachusetts, United States