Perioperative Intervention to Improve Post-TKR Support and Function

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia Franklin, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00566826
First received: November 30, 2007
Last updated: February 24, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Osteoarthritis
Arthroplasty, Replacement, Knee
Behavioral: Patient support sessions
Behavioral: Treatment as usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Intervention to Improve Post-TKR Support and Function

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566826

Locations
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
Investigators
Principal Investigator: Patricia D. Franklin, MD University of Massachusetts, Worcester
Study Director: Milagros C. Rosal, PhD University of Massachusetts, Worcester
  More Information

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Franklin, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00566826     History of Changes
Other Study ID Numbers: R01 AR054479, R01AR054479, H 12601
Study First Received: November 30, 2007
Last Updated: February 24, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
Physical Function
Total Knee Replacement
Physical Activity
Behavioral Support
Arthroplasty
Function
Self-Care

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014