C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

NCT02765035 | Completed Results DMC

• 1 other identifier: PD-PS00120010A-001
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.

Conditions

Lower Limb Amputation Above Knee (Injury)

Outcome Measures

Primary Outcomes (1)

• Change in 6 Minute Gait Test

  A measure of walking endurance, the distance walked in meters after 6 minutes.

  Baseline and after acclimation period (30-90 days after fitting)

Secondary Outcomes (9)

• Change in 10 Meter Gait Test

  Baseline and after acclimation period (30-90 days after fitting)

• Change in Stairs Assessment Index (SAI)

  Baseline and after acclimation period (30-90 days after fitting)

• Change in Hill Assessment Index (HAI)

  Baseline and after acclimation period (30-90 days after fitting)

• Change in Four Step Square Test (FSST)

  Baseline and after acclimation period (30-90 days after fitting)

• Change in Activities-specific Balance Confidence (ABC) Scale

  Baseline and after acclimation period (30-90 days after fitting)

Study Arms (2)

C-Leg 3, then C-Leg 4

EXPERIMENTAL

Participants are first fitted with a C-Leg 3, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 4, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Device: C-Leg 4; Device: C-Leg 3

C-Leg 4, then C-Leg 3

EXPERIMENTAL

Participants are first fitted with a C-Leg 4, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 3, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Device: C-Leg 4; Device: C-Leg 3

Interventions

C-Leg 4 DEVICE

Microprocessor Controlled Knee

C-Leg 3, then C-Leg 4; C-Leg 4, then C-Leg 3

C-Leg 3 DEVICE

Microprocessor Controlled Knee

C-Leg 3, then C-Leg 4; C-Leg 4, then C-Leg 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person is \>18 years old.
• Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
• Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
• Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
• Person was never fitted with microprocessor controlled prosthetic knee joint.
• Person is willing and able to independently provide informed consent.
• Person is willing to comply with study procedures.
• Person wears prosthesis daily and ≥ 8 hours/day.
• Person is walking on average 1km/day.
• Person is walking not slower than 3km/h (\~0.8m/s) (based on 10m walk test conducted during recruiting).
• Person is walking on level ground in a step over step manner.

You may not qualify if:

• Person is under 18 years of age.
• Person who weighs more than 136kg.
• Person who weighs less than 50kg.
• Person who is pregnant.
• Person has a history of chronic skin breakdown on the residual limb.
• Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
• Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
• Person is using under arm axillary crutches or walker.
• Person in an emergency, life threatening situation.
• Person is unwilling/unable to follow instructions.
• Person who is not available to follow the entire study protocol.
• Person who is participating in another study or intends to participate in another study during this study duration.
• Person who cannot personally provide their consent.
• Person who is not wearing prosthesis 8hours/day on average.
• Person who has a score on 10m walk test less than 3km/h (\~0.8m/s) (based on 10m walk test conducted during recruiting).

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead

Study Sites (2)

Orthopedic Rehabilitation Center SKA Zicksee

Sankt Andrä am Zicksee, Burgenland, 7161, Austria

Location

University Leuven

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

From 11 subjects that participated in the study, only 7 followed protocol. From post-hoc power analysis, 22 subjects would be required for 80% power to detect a difference of 35.9m (standard deviation = 30.3m) in the 6MWT. Patients were aware that a walking speed of greater than 0.8 m/s was a prerequisite for study participation, which could have lead to bias (elevated baseline measurement) and explain the small change in observed walking speed with C-Leg 3 and C-Leg 4 compared to baseline.

Results Point of Contact

• Title: Director of Clinical Research and Services Vienna
• Organization: Otto Bock Healthcare GmbH

Milana.Mileusnic@Ottobock.com

+4315233786733

Study Officials

• Stephan Domayer, Prim.Dr.

  Orthopedic Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: April 1, 2016
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); AU (1)