Trials / Active Not Recruiting
Active Not RecruitingNCT04784429
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Otto Bock Healthcare Products GmbH · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.
Detailed description
Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.
Conditions
- Lower Limb Amputation Above Knee (Injury)
- Congenital Amputation of Lower Limb
- Lower Limb Amputation Knee
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kenevo or C-Leg 4 | Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s. |
| DEVICE | Non microprocessor controlled knee (NMPK) | NMPK consistent with current standards of care |
Timeline
- Start date
- 2021-06-11
- Primary completion
- 2023-06-29
- Completion
- 2026-12-31
- First posted
- 2021-03-05
- Last updated
- 2024-02-09
Locations
90 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04784429. Inclusion in this directory is not an endorsement.