Clinical trial NCT00566826: Perioperative Intervention to Improve Post-TKR Support and Function
Official title: Perioperative Intervention to Improve Post-TKR Support and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Arthroplasty, Replacement, Knee
Keywords: Physical Function
Total Knee Replacement
Physical Activity
Behavioral Support
Arthroplasty
Function
Self-Care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-12-04
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Physical function (SF36, WOMAC)
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
measure: Physical activity and exercise
timeFrame: Measured at Months 6 and 12
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Patricia D. Franklin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Milagros C. Rosal, PhD
role: STUDY_DIRECTOR
References:
citation: Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index. J Bone Joint Surg Am. 2013 Oct 16;95(20):1833-7. doi: 10.2106/JBJS.L.01007.
citation: Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/humanfactors.8568.
citation: Oatis CA, Johnson JK, DeWan T, Donahue K, Li W, Franklin PD. Characteristics of Usual Physical Therapy Post-Total Knee Replacement and Their Associations With Functional Outcomes. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1171-1177. doi: 10.1002/acr.23761.
citation: Rosal MC, Ayers D, Li W, Oatis C, Borg A, Zheng H, Franklin P. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement. BMC Musculoskelet Disord. 2011 Oct 7;12:226. doi: 10.1186/1471-2474-12-226.