Osteoarthritis Clinical Trial
Official title:
Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite - on Short Term Outcomes in Adults After Partial or Total Knee Arthroplasty
NCT number | NCT02900781 |
Other study ID # | L16-138 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 21, 2016 |
Est. completion date | November 2017 |
Verified date | August 2019 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of the
knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee
Arthroplasty performed in a population that is aging during a time where the amount of
healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote
monitoring of rehabilitation and to engage and optimize self-management of recovery.
Current management of Partial or Total Knee Arthroplasty recovery is typically performed in
the out-patient setting and is highly protocol driven. A typical case might be seen by the
physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor
progress (i.e. compliance with ROM and strengthening exercises). One recent study suggested
that variation in patients' independent exercise and activity after arthroplasty surgery may
contribute to variable functional gains.
The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert
that collects functional data) will reduce cost and improve the efficacy of rehabilitation in
total knee arthroplasty patients
Status | Terminated |
Enrollment | 9 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Unilateral partial or total knee arthroplasty. - Age 45-75 yr. old - BMI <35 - Access to Wi-Fi - Have appropriate smart phone and knowledge of use - Be willing to place StepRite app on their personal phone Exclusion Criteria: - History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke). - Pregnancy - History of cognitive disease that would preclude ability to navigate smart phone |
Country | Name | City | State |
---|---|---|---|
United States | TTUHSC Orthopaedic Surgery MS 9436 | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center | MedHab, LC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of Step Rite Device | Effectiveness of outcomes with the use of the StepRite device | 3 months |
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