An interventional study of Formal Rehabilitation Therapy and Independent Exercise Cohort in Recovery Following Primary Total Knee Arthroplasty, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
In this study we plan to compare the efficacy of independent exercises performed by the patients at home to formal rehabilitation therapy following primary total knee replacement. Patients will be randomized to these two cohorts at enrollment into the study and followed prospectively. Patients randomized to the formal rehabilitation cohort will receive a prescription for therapy for twelve weeks. Patients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced joint.
At enrollment, a baseline evaluation will be conducted to capture demographics, height, weight, primary diagnosis, medical comorbidities, and social supports as well as completion of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with use of the Short Form-12v2 (SF-12v2) and activity level with the University of California, Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score questionnaires. Statistical analysis will be performed to compare the outcomes between the two cohorts.
Hypothesis:
There will be no difference in outcomes between formal rehabilitation and independent exercises at twelve months after primary total knee replacement surgery using the American Knee Society (AKS) Knee Score.
We will randomize patients who are scheduled to have primary total knee arthroplasty to receive either a prescription for formal physical therapy (PT) or instructions for independent exercises. Inclusion criteria will be: scheduled for primary total knee arthroplasty, an age of eighteen years or older, speak English, and have a computer with access to the Internet. Exclusion criteria will be: any knee arthroplasty other than total knee, patients not planning to return for follow up care, patients relying on others for basic functioning, do not speak English, and do not have a computer with access to the Internet. Enrollment will occur at the initial clinic visit in the surgeon's office.
Informed consent will be received from patients who will participate in the study at the initial clinic visit and these patients will be randomized equally to either the PT/OT or independent exercise cohort using the REDCap website randomization feature. REDCap is a secure, web-based application for building and managing online surveys and databases that will be utilized for this study for data management. Patients that will be randomized to PT cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.
The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform postoperatively to gradually regain their knee strength and range of motion.
Post-operative weeks 0 - 1, the patients will perform three sets of ten repetitions everyday of: supine ankle pumps, supine heel slides, seated quad sets, supine glut sets, and supine hip abduction/adduction. The patient will also perform three sets of patella mobilization for one minute each and three sets of one repetition of supine knee extension.
Post-operative weeks 1 - 2, the patients will perform three sets of ten repetitions everyday of: supine heel slides, prone knee flexion, supine knee extension, supine SLR flexion, sidelying SLR abduction, prone SLR extension, sidelying SLR adduction. The patient will also perform three sets of patella mobilization for one minute each and three sets of one repetition of supine knee extension with weight.
Post-operative weeks 2 - 4, the patients will perform three sets of ten repetitions everyday of: standing knee extension, standing knee flexion, standing SLR flexion, standing SLR abduction, standing SLR extension, standing SLR adduction. The patient will also perform three sets of patella mobilization for one minute each, three sets of sitting hamstring stretch for thirty seconds each, prone quad stretch for thirty seconds each, and three sets of single leg stance for thirty seconds each.
Post-operative weeks 4 - 8, the patients will perform three sets of ten repetitions everyday of: bilateral mini squats, standing SLR flexion, standing SLR abduction, standing SLR extension, standing SLR adduction. The patient will also perform three sets of sitting hamstring stretch for thirty seconds each and prone quad stretch for thirty seconds each.
Post-operative weeks 8 - 12, the patients will perform three sets of ten repetitions everyday of: bilateral wall squats, forward step-ups, and side step-ups. The patient will also perform three sets of sitting hamstring stretch for thirty seconds each and prone quad stretch for thirty seconds each. Patients will be advised to perform these exercises as often as possible, but at least once a day.
All patients will have regularly scheduled follow-up visits per usual practice at six-weeks post-operatively, six-months post-operatively, and 12-months post-operatively where a physical exam will be performed to check the range of motion of the knee, gait, and lower leg muscle strength.
The primary outcome of the trial will be to evaluate the efficacy of formal therapy compared with independent exercises at twelve months after surgery with use of the American Knee Society (AKS) Knee Score. Secondary outcomes will include the Knee and Osteoarthritis Outcome Score (KOOS) the measurement of health status with use of the Short Form-12v2 (SF-12v2) and activity level with the University of California, Los Angeles (UCLA) Activity Score.
At enrollment, a baseline evaluation will be conducted to capture demographics, height, weight, primary diagnosis, medical comorbidities, and social supports as well as completion of the selected outcome measures, AKS, KOOS, SF-12v2, and UCLA Activity Score. At the twelve-week, six-month and twelve-month follow-up visits, the study subjects will complete the AKS, KOOS, SF-12v2, and UCLA Activity Score questionnaires during their clinic visit or will be contacted by telephone or mail to complete the questionnaires if they do not have appointments for twelve-week, six-month or twelve-month follow-ups.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Patients randomized to the formal rehabilitation therapy cohort will receive a prescription for therapy for twelve weeks following their primary knee replacement.
Procedure: Formal Rehabilitation Therapy
Patients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced knee.
Procedure: Independent Exercise Cohort
Patients that will be randomized to the formal rehabilitation therapy cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.
Also known as: Physical Therapy
The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform post-operatively to gradually regain their knee strength, flexion, extension, abduction, and adduction.
Knee Function
The American Knee Society Score (AKS) consists of two parts. The first is the Knee Score, which considers pain, stability and range of motion as the main parameters, with deductions for flexion contractures, extension lag and malalignment. The second part, the Function Score, utilizes walking distance and stair climbing as the main parameters with deductions for the use of a walking aid.
Time frame: up to 12 months post-operatively
General physical and mental health
The Short Form 12v2 (SF-12v2) is an abbreviated version of the Short Form-36 (SF-36) that includes the physical and emotional limitations that are placed on work and social activities. The SF-12v2 measures how individuals value their current health state. It has been shown to be reliable (Pearson r \> 0.70), valid (highly correlated with SF-36), and responsive for the measurements of health status in many patient populations.
Time frame: up to 12 months post-operatively
Activity Level
The UCLA Activity Score assesses an individual's level of activity. The evaluation has ten descriptive activity levels ranging from wholly inactive and dependent on others (level 1), to moderate activities such as unlimited housework and shopping (level 6), to regular participation in impact sports such as jogging or tennis (level 10). The individual is asked to pick the statement that best describes their activity level.
Time frame: up to 12 months post-operatively
Knee and Osteoarthritis Outcome Score (KOOS)
The KOOS is a self-administered 40-item questionnaire used to assess patient-relevant outcomes in five separate subscales related to the knee (pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life). The KOOS contains all Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questions in unchanged form, so a WOMAC score can be calculated from the KOOS. The WOMAC is used to assess pain, function, and stiffness of the knee.
Time frame: up to 12 months post-operatively
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