Brief Summary

The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL). Device(s) being tested: Interchangeably: Direct Socket TF; DS-TF; DS Trans-femoral. The DS-TF is a trans-femoral (TF) set-up of the currently marketed trans-tibial version. It is not marketed in the USA and has not been registered with the FDA. The comparator is the current socket the subject is using when enrolled in the study. Subjects recruited: Minimum 50 Inclusion criteria: 50Kg\< body weight \< 160Kg Cognitive ability to understand all instructions and questionnaires in the study; Patients who have undergone a transfemoral amputation \> 1 year post amputation Older than 18 years Willing and able to participate in the study and follow the protocol Circular dimension of 40-65 cm at the crotch Residual limb length at least 20 cm from ischium to distal end Currently using a prosthetic liner Locking users that can successfully be fitted with Iceross® Transfemoral Locking, OR Seal-In users that can successfully be fitted with either Iceross Seal-In® X5 TF or Iceross Transfemoral Seal-In® Exclusion criteria: 50Kg\> body weight \> 160Kg Users with cognitive impairment Patients who have undergone a transfemoral amputation \<1 year post amputation Younger than 18 years Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons Circular dimension of less than 40 cm or greater than 65 cm at the crotch Residual limb length less than 20 cm from ischium to distal end Currently not using a prosthetic liner

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach

1 country

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

April 30, 2018

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed

16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed

Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

March 16, 2020

Last Update Submit

November 18, 2020

Conditions

Amputation

Keywords

Trans-femoral stump mobility pain usability service socket

Outcome Measures

Primary Outcomes (8)

OPUS
Patient Self report. Paper based. Evaluation of service and device.
6 months
CLASS
Amputee Self-report: socket quality evaluation (comfort, pain, stability, aesthetics); collected with ProApp.
6 months
AmpPro
CPO evaluation of amputee, objective scoring: activity/mobility; collected with ProApp.
6 months
PLUS-M
Amputee Self-report: activity/mobility; collected with ProApp.
6 months
EQ-5D
Amputee self report: QoL, paper based.
6 months
ABC
Amputee self report: Activity-Balance Confidence scale; collected with ProApp.
6 months
TUG
Activity: Timed up and go; collected with ProApp.
6 months
CPO usability
In-house generated instrument; paper based
6 months

Secondary Outcomes (1)

Observation log
Baseline only

Study Arms (2)

Clinical need

ACTIVE COMPARATOR

Participants enrolled that require a new socket.

Device: Direct Socket TF

No clincal need

EXPERIMENTAL

Participants enrolled that do not require a new socket

Device: Direct Socket TF

Interventions

Direct Socket TFDEVICE

The device is Class I, a low-risk product, and is a further development of a well-established technology. Össur Direct Socket (DS) technology has been on the market since 1996 (ICEX first generation) for the manufacture of leg prosthesis. This prosthetic socket for trans-femoral amputees (referred hereby to as DS-TF) has the same basic functional design as the Direct Socket (MSS) for trans-tibial amputees (referred hereby to as DS-TT) that is available on the market today in addition to the newly added silicon brim. A prosthetic socket is a non-invasive, non-sterile, single user reusable device, which is used as part of prosthetic system. The aspect of the prosthesis that is in direct physical contact with the amputee is usually not the socket, to which a prosthesis is connected to, but the liner that serves as an interface between the amputee and the rest of the prosthesis. An amputee typically wears a prosthesis and thereby utilizes a socket, for up to 18 hours a day.

Also known as: DS-TF, DS Trans-femoral

Clinical needNo clincal need

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Cognitive ability to understand all instructions and questionnaires in the study.
Patients who have undergone a trans-femoral amputation \> 1 year post amputation.
Willing and able to participate in the study and follow the protocol.
Circular dimension of 40-65 cm at the crotch.
Residual limb length at least 20 cm from ischium to distal end.

You may not qualify if:

Kg \> body weight \> 160Kg
Users with cognitive impairment
Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Össur Iceland ehflead

Study Sites (17)

Alabama Artificial Limb Specialists

Mobile, Alabama, 36606, United States

Location

Alabama Artificial Limb Specialists

Montgomery, Alabama, 36116, United States

Location

Alabama Artificial Limb Specialists

Opelika, Alabama, 36801, United States

Location

Van Der Watt Prosthetics & Orthotics

Greenwood, Arkansas, 72936, United States

Location

Tillges Certified Orthotic Prosthetic Inc

Maplewood, Minnesota, 55109, United States

Location

Sampson's Prosthetics Lab

Albany, New York, 12206, United States

Location

Sampson's Prosthetics Lab

Schenectady, New York, 12304, United States

Location

Eastside Orthotics and Prosthetics

Portland, Oregon, 97230, United States

Location