- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279277
Physical Therapy Prior to Total Knee Replacement
October 28, 2014 updated by: Rothman Institute Orthopaedics
Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement.
Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
148
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
- Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
- Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction
Exclusion Criteria:
- Anyone who received physical therapy in the last 6 months
- Inability to walk unaided for >1 block
- Currently engaged in regular PT or a regular home exercise program
- Prior knee arthroplasty
- Prior knee surgery for trauma, tumor and osteotomy
- Injection given within 6 weeks of starting therapy
- Patients using daily narcotic medications within prior 6 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No physical therapy
No prescribed, supervised physical therapy prior to total knee replacement
|
|
Active Comparator: Physical Therapy
Prescribed, supervised physical therapy prior to total knee replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Range of Motion following Total Knee Replacement
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient reported perception of pain following total knee replacement
Time Frame: 6 weeks
|
6 weeks
|
Return to functional activities following total knee replacement
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
October 6, 2014
First Submitted That Met QC Criteria
October 28, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
October 31, 2014
Last Update Submitted That Met QC Criteria
October 28, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Austin2014
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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