N/A N=50 Treatment

Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Lower Limb Amputation Above Knee (Injury)

Bottom Line

View on ClinicalTrials.gov: NCT02240186 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Daily Activity Measured With Triaxial Accelerometers — 15.64; 19.68; 18.23 % of Day — p=0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Microprocessor Knee (MPK) (Device); Non-Microprocessor Knee (NMPK) (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Daily Activity Measured With Triaxial Accelerometers	15.64; 19.68; 18.23	0.01 sig
PRIMARY Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)	2.0; 0.0; 3.0	0.01 sig
SECONDARY Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)	39.07; 49.58; 45.31; 64.55; 74.43; 62.80	0.01 sig

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02240186). 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.