- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377102
Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Orthopaedics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Observational
Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy.
At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty.
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Active Comparator: Physical Therapy
Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice.
No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice.
The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures.
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12 weeks of supervised physical therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of surgical intervention questionnaire
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Investigators
- Study Director: Daniel J Del Gaizo, MD, UNC Orthopaedics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-2152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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