Perioperative Intervention to Improve Post-TKR Support and Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Osteoarthritis Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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1

Patient support treatment sessions

Group Type EXPERIMENTAL

Patient support sessions

Intervention Type BEHAVIORAL

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

2

Treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Treatment as usual includes standard care for TKR surgery rehabilitation.

Interventions

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Patient support sessions

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

Intervention Type BEHAVIORAL

Treatment as usual

Treatment as usual includes standard care for TKR surgery rehabilitation.

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No