An Investigation Into a New Manufacture Technique of Trans-femoral Sockets

Sponsor

Össur Ehf (Industry)

Overall Status

Completed

CT.gov ID

NCT04312724

Collaborator

(none)

Enrollment

Locations

Arms

26.1

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Amputation	Device: Direct Socket TF	N/A

Detailed Description

The test will be a single group prospective pre/post design. Amputees are a small proportion of the general population. The population group specified in the inclusion/exclusion criteria is a further subsample of amputees. For practical reasons, i.e. to achieve statistical power, it is therefore more feasible to use within-subject comparison rather than creating study arms to compare. Furthermore, as mobile amputees generally have and use a prosthetic device for their daily activities, within-comparison is feasible comparing to the subjects' previous device.

All investigational activities will be conducted at prosthetic out-patient clinics.

As stated above the primary endpoint is successful use rate, see Table 2, and the secondary endpoints are listed in the table from B-H in that respective order of significance. See previous chapter on objectives and hypothesis and Table 2 for rationale.

Drop-outs and withdrawals will not be replaced.

Equipment required for each subject:

Pen/pencil
Printed out instruments
Investigational device: Materials for making DS-TF socket o Designated locking or seal-in liner to be fitted with the socket

Additionally, each LPI or LCI will have access to:

Equipment for DS-TF socket manufacturing
iPad with the Össur ProApp installed for data collection The equipment used does not require specific monitoring, maintenance or calibration procedures.

The purpose of the study is to evaluate in a cohort the time it takes to manufacture and delivery (lead time) of a definitive prosthesis (definition of finished prosthetic leg is, a prosthesis that is individually tailored and able to be used both indoors and outdoors, with the maximum weight on the patient equivalent to 160 kg). The existing prosthesis is to be evaluated as well as the new socket. The evaluation of function will take place at baseline, 6 weeks and 6 months after deliverance.

The following outcome instruments will be used:

• At all three study evaluation points; initial fitting, 6 wees and 6 months:

OPUS (LEFS, CSD, CSS) https://www.sralab.org/rehabilitation-measures/orthotics-prosthetics-users-survey
ProAMP (to test the current function with prosthesis)
EQ-5D (for life quality)
Socket Comfort Score (SCS)
CLASS - socket fit
Plus-M
ABC
TUG

Cost of fitting, to all parties, will be collected and reported. Whatever the outcome of the study will be, it will be very informative for healthcare systems, both payers and providers, and manufacturer of equipment for amputees.

The total time required to implement the full clinical investigation is expected to be approximately 26 months. Each individual subject is expected to participate in the clinical investigation for a minimum of 6 weeks, up to 6 months. The estimated time needed to include the required number (enrolment period) is 20 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

MSS - Clinical Investigation An Investigation of a New Manufacture Technique of a Trans-femoral Socket and Its Function for Amputees.

Actual Study Start Date :

Apr 30, 2018

Actual Primary Completion Date :

Jun 15, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clinical need Participants enrolled that require a new socket.	Device: Direct Socket TF 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. Other Names: DS-TF DS Trans-femoral
Experimental: No clincal need Participants enrolled that do not require a new socket	Device: Direct Socket TF 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. Other Names: DS-TF DS Trans-femoral

Arm

Intervention/Treatment

Active Comparator: Clinical need

Participants enrolled that require a new socket.

Device: Direct Socket TF

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.

Other Names:

DS-TF

DS Trans-femoral

Experimental: No clincal need

Participants enrolled that do not require a new socket

Device: Direct Socket TF

Other Names:

DS-TF

DS Trans-femoral

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Observation log [Baseline only]
Timing and documentation on how the DS-TF is fitted.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

50Kg > body weight > 160Kg
Users with cognitive impairment
Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Artificial Limb Specialists	Mobile	Alabama	United States	36606
2	Alabama Artificial Limb Specialists	Montgomery	Alabama	United States	36116
3	Alabama Artificial Limb Specialists	Opelika	Alabama	United States	36801
4	Van Der Watt Prosthetics & Orthotics	Greenwood	Arkansas	United States	72936
5	Tillges Certified Orthotic Prosthetic Inc	Maplewood	Minnesota	United States	55109
6	Sampson's Prosthetics Lab	Albany	New York	United States	12206
7	Sampson's Prosthetics Lab	Schenectady	New York	United States	12304
8	Eastside Orthotics and Prosthetics	Portland	Oregon	United States	97230
9	Union Orthotics & Prosthetics Co	Cranberry Township	Pennsylvania	United States	16066
10	Union Orthotics & Prosthetics Co	E. Rochester	Pennsylvania	United States	15074
11	Union Orthotics & Prosthetics Co	Greensburg	Pennsylvania	United States	15601
12	Union Orthotics & Prosthetics Co	Pittsburgh	Pennsylvania	United States	15201
13	Union Orthotics & Prosthetics Co	Pittsburgh	Pennsylvania	United States	15236
14	Victory Orthotics and Prosthetics Inc.	Johnson City	Tennessee	United States	37604
15	Victory Orthotics and Prosthetics Inc.	Kingsport	Tennessee	United States	37660
16	Victory Orthotics and Prosthetics Inc.	Knoxville	Tennessee	United States	37922
17	Virginia Prosthetics and Orthotics	Roanoke	Virginia	United States	24012

Sponsors and Collaborators

Össur Ehf

Investigators

Principal Investigator: Justin Pratt, CPO, Össur Ehf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Össur Ehf

ClinicalTrials.gov Identifier:

NCT04312724

Other Study ID Numbers:

CIP2017122866

First Posted:

Mar 18, 2020

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Össur Ehf

Trans-femoral stump mobility pain usability service socket

Study Results

No Results Posted as of Nov 20, 2020