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Perioperative Intervention to Improve Post-TKR Support and Function

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ClinicalTrials.gov Identifier: NCT00566826
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : February 26, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Patricia Franklin, University of Massachusetts, Worcester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthroplasty, Replacement, Knee Behavioral: Patient support sessions Behavioral: Treatment as usual Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Intervention to Improve Post-TKR Support and Function
Study Start Date : June 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ]

Secondary Outcome Measures :
  1. Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566826


Locations
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United States, Massachusetts
University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Patricia D. Franklin, MD University of Massachusetts, Worcester
Study Director: Milagros C. Rosal, PhD University of Massachusetts, Worcester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Patricia Franklin, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00566826    
Other Study ID Numbers: R01AR054479 ( U.S. NIH Grant/Contract )
R01AR054479 ( U.S. NIH Grant/Contract )
H 12601 ( Other Identifier: University of Massachusetts Medical School )
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Patricia Franklin, University of Massachusetts, Worcester:
Physical Function
Total Knee Replacement
Physical Activity
Behavioral Support
 Arthroplasty
Function
Self-Care
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases