MPK vs NMPK Prosthetics for Above-Knee Amputation (ASCENT K2 Trial)

Palo Alto (17 mi)

Overseen byShane Wurdeman, PhD

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Otto Bock Healthcare Products GmbH

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests advanced artificial knees with built-in computers in above-knee or knee-level amputees who have limited walking ability. The goal is to see if these knees can reduce fear of falling, improve quality of life, and increase participation in activities. These advanced knees are well-established devices that significantly increase patient safety, walking ability, and performance in daily activities.

Eligibility Criteria

This trial is for individuals aged 65 or older who have had an above-knee amputation and are currently using a prosthesis they received between 4-24 months ago. They must be K2 ambulators, comfortable with their socket (score of at least 6/10), and speak English or Spanish. People over 275 lbs, with limb issues, multiple socket changes, serious health declines, cancer, or those pregnant cannot join.

Inclusion Criteria

I am 65 years old or older.

I have had an amputation above or through my knee on one leg.

Exclusion Criteria

I have had my opposite limb amputated.

I am unable to understand and agree to the study's details on my own.

I currently have cancer.

I am unable or unwilling to follow the study's required procedures.

I have had 2 or more adjustments or replacements of my prosthetic socket in the last 6 months.

I am not pregnant, institutionalized, or a child.

I have had issues with my amputated limb not healing properly.

I weigh 275 lbs or more.

My upper limb is affected.

Treatment Details

The study compares two types of knee prostheses in people who've lost a leg above the knee: microprocessor-controlled knees (like Kenevo or C-Leg 4) versus non-microprocessor knees. Participants will be randomly assigned to one of these options to see which works better for daily activities.

2Treatment groups

Experimental Treatment

Active Control

Group I: MPKExperimental Treatment1 Intervention

Microprocessor controlled knee

Group II: NMPKActive Control1 Intervention

Non-microprocessor controlled knee