Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732962
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-01-26
Brief Title:
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Sponsor:
Geisinger Clinic
Organization:
Geisinger Clinic
Study Overview
Official Title:
The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoarthritis OA the most common type of arthritis affects more than 325 million adults in the United States It is also among the most expensive condition to treat when joint replacement surgery is required Although biomechanics plays an important role in OA disease the non-surgical treatment options addressing biomechanics are scarce with limited effect AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA
The main objectives of this study are
1 To assess AposHealth a non-invasive home-based biomechanical treatment as an alternative treatment for patients who are eligible for Total Knee Replacement TKR
2 To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR
The main objectives of this study are
1 To assess AposHealth a non-invasive home-based biomechanical treatment as an alternative treatment for patients who are eligible for Total Knee Replacement TKR
2 To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR
Detailed Description:
Osteoarthritis OA the most common type of arthritis affects more than 325 million adults in the United States It is also among the most expensive condition to treat when joint replacement surgery is required Future projections of the prevalence of OA predict an increase in prevalence mainly due to the aging of the population and obesity
Total knee replacement TKR is the end-stage solution for patients with knee OA The total annual cost of arthritis in the US in 2013 reached over 300 billion Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs
Successful and beneficial non-invasive treatment options for knee OA are limited More specifically although biomechanics plays an important role in OA disease the non-surgical treatment options addressing biomechanics are scarce with limited effect AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA
The main objectives of this study are
1 To assess AposHealth a non-invasive home-based biomechanical treatment as an alternative treatment for patients who are eligible for TKR
2 To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR
Total knee replacement TKR is the end-stage solution for patients with knee OA The total annual cost of arthritis in the US in 2013 reached over 300 billion Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs
Successful and beneficial non-invasive treatment options for knee OA are limited More specifically although biomechanics plays an important role in OA disease the non-surgical treatment options addressing biomechanics are scarce with limited effect AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA
The main objectives of this study are
1 To assess AposHealth a non-invasive home-based biomechanical treatment as an alternative treatment for patients who are eligible for TKR
2 To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None