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Clinical Trials/NCT00566826
NCT00566826
Completed
Phase 2

Perioperative Intervention to Improve Post-TKR Support and Function

University of Massachusetts, Worcester1 site in 1 country196 target enrollmentJune 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Massachusetts, Worcester
Enrollment
196
Locations
1
Primary Endpoint
Physical function (SF36, WOMAC)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
August 2012
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Patricia Franklin

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Physical function (SF36, WOMAC)

Time Frame: Measured at Months 6 and 12

Secondary Outcomes

  • Physical activity and exercise(Measured at Months 6 and 12)

Study Sites (1)

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