N/A
N=25
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Other and Unspecified Complications of Amputation Stump
Bottom Line
View on ClinicalTrials.gov: NCT01473992 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: 75 Meter Self Selected Walking Test — 65.1; 64.0; 54.0 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Otto Bock C-Leg (Device); Otto Bock Genium (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jason Highsmith
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 75 Meter Self Selected Walking Test |
65.1; 64.0; 54.0 | — |
| PRIMARY Physical Functional Performance (Continuous Scale; 10-items) |
55.2; 59.6; 73.04 | — |
| SECONDARY Balance and Stability |
60.7; 59.2; 73.1 | — |
| SECONDARY Prosthesis Evaluation Questionnaire: Utility Score. |
6.0; 5.5 | — |
Summary
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.
Eligibility Criteria
Inclusion criteria
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Current use of and experience with the C-Leg for at least 1 year
- Ability to descend stairs and hills without caregiver and assistive devices
- Be able to independently provide informed consent
- Be willing to comply with study procedures.
Exclusion criteria
- History of chronic skin breakdown on the residual limb
- Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- Unwillingness/inability to follow instructions
Data sourced from ClinicalTrials.gov (NCT01473992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.