Status:
COMPLETED
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Lead Sponsor:
Össur Iceland ehf
Collaborating Sponsors:
Medical Center Orthotics and Prosthetics
Conditions:
Prosthesis User
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic...
Detailed Description
This is a prospective two group cross-over study, within subject comparison. 3 study visits are planned for amputee subjects, with approximately 2-3 weeks between visits, and an optional fourth visit ...
Eligibility Criteria
Inclusion
- 50Kg\< body weight \< 116Kg
- K3-K4 amputees with unilateral transfemoral amputation or Knee disarticulation
- Allows for 37mm knee center height to dome of pyramid alignment
- Currently using a MPK or Power Knee
- Older than 18 years old
- No socket issues/changes in the last 6 weeks and no socket changes expected during the duration of the study period.
- Comfortable and stable socket fit
- Willing and able to participate in the study and follow the protocol
Exclusion
- 50Kg\> body weight \> 116Kg
- Bilateral amputees
- Users with socket problems
- Users with co-morbidities in the contra-lateral limb, which affect their functional mobility
- Younger than 18 years old
- Users with stump pain
- Users with cognitive impairment
- Users not involved in other clinical tests and/or receiving treatment that the testing might affect.
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04787627
Start Date
November 18 2019
End Date
July 6 2020
Last Update
September 22 2025
Active Locations (2)
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1
Medical Center Orthotics and Prosthetics
Silver Spring, Maryland, United States, 20910
2
Medical Center Orthotics and Prosthetics
Boston, Massachusetts, United States, 02134