Clinical trial NCT02240186: Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
Official title: Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Above Knee (Injury)
Keywords: Microprocessor-controlled knee
prosthesis
amputation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American Orthotic and Prosthetic Association
First posted: 2014-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Unilateral transfemoral amputee
* Medicare Functional Classification Level K2 or K3
* Currently using NMPK prosthesis
* No current residual limb problems, such as skin breakdown
* Able to ambulate without a gait aid

Exclusion Criteria:

* Previous stroke or other neuromuscular complications currently affecting gait
* Currently undergoing dialysis treatments
* Amputation of the contralateral limb
* Poor fit of current NMPK prosthesis

Primary outcomes:
measure: Daily Activity Measured With Triaxial Accelerometers
timeFrame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
measure: Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
timeFrame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Secondary outcomes:
measure: Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
timeFrame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton R Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.