Trials / Completed
CompletedNCT02240186
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
Detailed description
The study design is a reversal design whereby only the prosthetic knee joint will be changed. Each subject will be tested using their current NMPK, fit and tested with a MPK, and then tested again with their NMPK. MPK prostheses from all manufacturers will be considered appropriate for testing. Each MPK to be used in this study is FDA approved. The foot will be in the L5981 class, e.g. flex foot or equivalent. The same socket, suspension, and foot will be used throughout the study in order to eliminate these confounding variables. All prosthesis fittings will be performed by the subject's own certified prosthetist according to manufacturers' fitting guidelines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Microprocessor Knee (MPK) | MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness. |
| DEVICE | Non-Microprocessor Knee (NMPK) | A NMPK is a mechanical knee with either hydraulic or pneumatic controls. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2017-06-01
- Completion
- 2017-12-01
- First posted
- 2014-09-15
- Last updated
- 2018-12-12
- Results posted
- 2018-12-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02240186. Inclusion in this directory is not an endorsement.