Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

NCT01473992 | Completed Results DMC

• 1 other identifier: 6140101200
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Other and Unspecified Complications of Amputation Stump

Outcome Measures

Primary Outcomes (2)

• 75 Meter Self Selected Walking Test

  Time to Complete a 75 meter walking distance.

  Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

• Physical Functional Performance (Continuous Scale; 10-items)

  Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.

  Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.

Secondary Outcomes (2)

• Balance and Stability

  Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

• Prosthesis Evaluation Questionnaire: Utility Score.

  Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

Study Arms (3)

Prosthetic knee 1 (Otto Bock C-Leg)

ACTIVE COMPARATOR

This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).

Device: Otto Bock C-Leg

Prosthetic knee 2 (Otto Bock Genium)

ACTIVE COMPARATOR

This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)

Device: Otto Bock Genium

Non-amputee controls

NO INTERVENTION

This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.

Interventions

Otto Bock C-Leg DEVICE

Amputees' preferred prosthetic knee.

Prosthetic knee 1 (Otto Bock C-Leg)

Otto Bock Genium DEVICE

Study knee.

Prosthetic knee 2 (Otto Bock Genium)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transfemoral or knee-disarticulation amputee
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Highsmith: lead
• Otto Bock Healthcare: collaborator
• Florida High Tech Corridor Council: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Results Point of Contact

• Title: M. Jason Highsmith
• Organization: University of South Florida

mhighsmi@health.usf.edu

8139743806

Study Officials

• M. Jason Highsmith, PT,DPT,CP

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: November 17, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 12, 2023
• Results First Posted: November 18, 2014

Record last verified: 2023-12

Locations

US (1)