Perioperative Intervention to Improve Post-TKR Support and Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Intervention to Improve Post-TKR Support and Function

Conditions
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Osteoarthritis, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Behavioral: Patient support sessions
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function (SF36, WOMAC) |  | Measured at Months 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity and exercise |  | Measured at Months 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Function, Total Knee Replacement, Physical Activity, Behavioral Support, Arthroplasty, Function, Self-Care