AmputationNCT04312724
An Investigation Into a New Manufacture Technique of Trans-femoral Sockets
A study testing Direct Socket TF in people with Amputation, run by Össur Iceland ehf at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Direct Socket TF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 17 sitesUnited States
- Study dates
- 30 Apr 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 50Kg > body weight > 160Kg
- Users with cognitive impairment
- Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Sampson's Prosthetics Lab
Albany, New York, 12206
Union Orthotics & Prosthetics Co
Cranberry Township, Pennsylvania, 16066
Union Orthotics & Prosthetics Co
East Rochester, Pennsylvania, 15074
Union Orthotics & Prosthetics Co
Greensburg, Pennsylvania, 15601
Van Der Watt Prosthetics & Orthotics
Greenwood, Arkansas, 72936
Victory Orthotics and Prosthetics Inc.
Johnson City, Tennessee, 37604
Victory Orthotics and Prosthetics Inc.
Kingsport, Tennessee, 37660
Victory Orthotics and Prosthetics Inc.
Knoxville, Tennessee, 37922
Tillges Certified Orthotic Prosthetic Inc
Maplewood, Minnesota, 55109
Alabama Artificial Limb Specialists
Mobile, Alabama, 36606
Alabama Artificial Limb Specialists
Montgomery, Alabama, 36116
Alabama Artificial Limb Specialists
Opelika, Alabama, 36801
Union Orthotics & Prosthetics Co
Pittsburgh, Pennsylvania, 15201
Union Orthotics & Prosthetics Co
Pittsburgh, Pennsylvania, 15236
Eastside Orthotics and Prosthetics
Portland, Oregon, 97230
Virginia Prosthetics and Orthotics
Roanoke, Virginia, 24012
Sampson's Prosthetics Lab
Schenectady, New York, 12304
About this study
Official title: MSS - Clinical Investigation An Investigation of a New Manufacture Technique of a Trans-femoral Socket and Its Function for Amputees.
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.
Read more
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
Read the 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.
- Conditions
- Amputation
- Being tested
- Direct Socket TF
- Keywords
- Trans-femoral stump mobility pain usability service socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Socket TFDevice
Also called DS-TF, DS Trans-femoral
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical need | Active comparator | Participants enrolled that require a new socket. Receives: Device: Direct Socket TF |
| No clincal need | Experimental | Participants enrolled that do not require a new socket Receives: Device: Direct Socket TF |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPUS
Patient Self report. Paper based. Evaluation of service and device.
Measured: 6 months
CLASS
Amputee Self-report: socket quality evaluation (comfort, pain, stability, aesthetics); collected with ProApp.
Measured: 6 months
AmpPro
CPO evaluation of amputee, objective scoring: activity/mobility; collected with ProApp.
Measured: 6 months
PLUS-M
Amputee Self-report: activity/mobility; collected with ProApp.
Measured: 6 months
EQ-5D
Amputee self report: QoL, paper based.
Measured: 6 months
ABC
Amputee self report: Activity-Balance Confidence scale; collected with ProApp.
Measured: 6 months
TUG
Activity: Timed up and go; collected with ProApp.
Measured: 6 months
CPO usability
In-house generated instrument; paper based
Measured: 6 months
Secondary outcomes (1)
Observation log
Timing and documentation on how the DS-TF is fitted.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start30 Apr 2018
- Primary completion15 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin Pratt, CPO, Principal investigator, Össur Iceland ehf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312724
- Sponsor's protocol ID
- CIP2017122866
- Status last verified
- Nov 2020
- First submitted
- 16 Mar 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSS - Clinical Investigation An Investigation of a New Manufacture Technique of a Trans-femoral Socket and Its Function for Amputees.
- ClinicalTrials.gov ID
- NCT04312724
- Acronym / sponsor ID
- CIP2017122866
- Conditions
- Amputation
- Keywords
- Trans-femoral stump mobility pain usability service socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical need | Active comparator | Device: Direct Socket TFParticipants enrolled that require a new socket. |
| No clincal need | Experimental | Device: Direct Socket TFParticipants enrolled that do not require a new socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 50Kg > body weight > 160Kg
- Users with cognitive impairment
- Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Socket TFAlso: DS-TF, DS Trans-femoralThe 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. | Device | Clinical need, No clincal need |
Primary outcome
OPUS
Time frame: 6 months
Patient Self report. Paper based. Evaluation of service and device.
CLASS
Time frame: 6 months
Amputee Self-report: socket quality evaluation (comfort, pain, stability, aesthetics); collected with ProApp.
AmpPro
Time frame: 6 months
CPO evaluation of amputee, objective scoring: activity/mobility; collected with ProApp.
PLUS-M
Time frame: 6 months
Amputee Self-report: activity/mobility; collected with ProApp.
EQ-5D
Time frame: 6 months
Amputee self report: QoL, paper based.
ABC
Time frame: 6 months
Amputee self report: Activity-Balance Confidence scale; collected with ProApp.
TUG
Time frame: 6 months
Activity: Timed up and go; collected with ProApp.
CPO usability
Time frame: 6 months
In-house generated instrument; paper based
1 secondary outcome
Observation log
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Pratt, CPO principal investigator
Össur Iceland ehf
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Socket TF in people with Amputation, run by Össur Iceland ehf at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPUS (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.