Knee Osteoarthritis
Conditions
Brief summary
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty. Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty. Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.
Interventions
PROCEDUREPhysical Therapy
12 weeks of supervised physical therapy.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
Exclusion criteria
* Age less than 18 y/o * Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc) * Previous knee surgery * Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation * known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of surgical intervention questionnaire | 12 weeks | Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score | 12 weeks | The PROMIS score incorporates questions from multiple validated instruments of functional outcome. The system was then calibrated to the normal population distribution and has been applied previously to assess lower extremity dysfunction. This will increase our sensitivity in detecting differences between the two groups. The CAT is an adaptive test that responds to previous patient responses to decrease the amount of questions required to obtain a score. This will allow our CAT to last 1-5 minutes as opposed to a longer patient reported score or system. PROMIS has also been utilized in the setting of arthritis and should allow for a greater detection of functional improvement. |
Countries
United States
Outcome results
None listed