AmputationNCT04038580

A Comparative Assessment of Transfemoral Prosthetic Sockets

A study testing Laminated Socket, Quatro and Infinite Socket in people with Amputation and Amputation; Traumatic, Leg, Lower, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amputation, Amputation; Traumatic, Leg, Lower
What is being tested?: Laminated Socket, Quatro and Infinite Socket
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: 15 Aug 2019to 1 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Unilateral lower-limb amputation
Six months of independent ambulation
Own and regularly wear a prosthesis with socket
Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"

Who cannot join

Pathology or injury of the intact limb
Medication that affects their ability to walk
Neurologic or cardiovascular disease
Significant vision problems
Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
Rosalind Franklin University
Chicago, Illinois, 60064

Other trials in United States

About this study

Official title: A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Read the detailed description

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?

Conditions: Amputation, Amputation; Traumatic, Leg, Lower
Being tested: Laminated Socket, Quatro, Infinite Socket, CJ Socket
Keywords: Socket, Transfemoral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laminated SocketDevice
This is the currently prescribed socket the participant normally wears.
QuatroDevice
The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
Infinite SocketDevice
The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
CJ SocketDevice
The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Study groups in NCT04038580
Study group	Role	What they receive
Prescribed Laminated Socket	Sham comparator	In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks. Receives: Device: Laminated Socket
Adjustable Sockets	Experimental	In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket. Receives: Device: Quatro; Device: Infinite Socket; Device: CJ Socket

What is being measured

The primary outcome is the main question the study is designed to answer.

Socket Fit Comfort Score
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Measured: After at least 3 weeks of prosthetic socket use
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health.
Measured: After at least 3 weeks of prosthetic socket use
Activities Specific Balance Confidence Scale
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Measured: After at least 3 weeks of prosthetic socket use
Mobility as Measured by the 10-meter Walk Test
The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials.
Measured: after at least 4 weeks of prosthetic socket use
Mobility as Measured by Timed Up and Go (TUG)
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded.
Measured: after at least 4 weeks of prosthetic socket use
Mobility as Measured by Five Times Sit To Stand (FTSTS)
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Measured: after at least 4 weeks of prosthetic socket use
Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form
The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average.
Measured: After at least 3 weeks of prosthetic socket use

Secondary outcomes (4)

Prosthetic Wear Time
Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week.
Measured: After at least 3 weeks of prosthetic socket use
Time to Complete the L Test
The L test is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side. The fastest time out of three trials was recorded.
Measured: After 4 weeks of prosthetic socket use
Steps Per Day Taken at Home
Participants will wear accelerometers to measure their average step count per day over a one week time frame. Data will be collected after at least three weeks of socket use.
Measured: After three weeks of device use
Prosthetic Preference
The prosthetic preference questionnaire consisted of a single question which asked which socket the participant preferred on a 100 mm visual analog scale from their prescribed socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the experimental socket.
Measured: After at least three weeks of prosthetic socket use.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20191 Jul 2024

First posted31 Jul 2019
Study start15 Aug 2019
Primary completion1 Jul 2024
Study completion1 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AmputationStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04038580
Sponsor's protocol ID: HUM00140733
Status last verified: Sep 2025
First submitted: 23 Jul 2019
Last updated: 29 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Participant data will be deidentified for publication.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management

All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets
ClinicalTrials.gov ID: NCT04038580
Acronym / sponsor ID: HUM00140733
Conditions: Amputation, Amputation; Traumatic, Leg, Lower
Keywords: Socket, Transfemoral
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 15 Aug 2019 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 1 Jul 2024 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 29 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prescribed Laminated Socket	Sham comparator	Device: Laminated SocketIn this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.
Adjustable Sockets	Experimental	Device: Quatro, Device: Infinite Socket, Device: CJ SocketIn this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Unilateral lower-limb amputation
Six months of independent ambulation
Own and regularly wear a prosthesis with socket
Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"

Key exclusion criteria (5 listed)

Pathology or injury of the intact limb
Medication that affects their ability to walk
Neurologic or cardiovascular disease
Significant vision problems
Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication

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
Laminated SocketThis is the currently prescribed socket the participant normally wears.	Device	Prescribed Laminated Socket
QuatroThe Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.	Device	Adjustable Sockets
Infinite SocketThe Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.	Device	Adjustable Sockets
CJ SocketThe CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.	Device	Adjustable Sockets

Primary outcome

Socket Fit Comfort Score
Time frame: After at least 3 weeks of prosthetic socket use
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Time frame: After at least 3 weeks of prosthetic socket use
The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health.
Activities Specific Balance Confidence Scale
Time frame: After at least 3 weeks of prosthetic socket use
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Mobility as Measured by the 10-meter Walk Test
Time frame: after at least 4 weeks of prosthetic socket use
The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials.
Mobility as Measured by Timed Up and Go (TUG)
Time frame: after at least 4 weeks of prosthetic socket use
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded.
Mobility as Measured by Five Times Sit To Stand (FTSTS)
Time frame: after at least 4 weeks of prosthetic socket use
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form
Time frame: After at least 3 weeks of prosthetic socket use
The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average.

4 secondary outcomes

Prosthetic Wear Time
Time frame: After at least 3 weeks of prosthetic socket use
Time to Complete the L Test
Time frame: After 4 weeks of prosthetic socket use
Steps Per Day Taken at Home
Time frame: After three weeks of device use
Prosthetic Preference
Time frame: After at least three weeks of prosthetic socket use.

Results and safety

Results posted to the registry on 29 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laminated, Then CJ, Then Infinite, Then Quatro	5	5
Laminated, Then CJ, Then Quatro, Then Infinite	5	5
Laminated, Then Infinite, Then CJ, Then Quatro	5	5
Laminated, Then Infinite, Then Quatro, Then CJ	5	5
Laminated, Then Quatro, Then Infinite, Then CJ	4	4
Laminated, Then Quatro, Then CJ, Then Infinite	5	5

Primary outcome: Socket Fit Comfort Score

Time frame: After at least 3 weeks of prosthetic socket use. Mean (Standard Error). Unit: units on a scale

Measure	Laminated Socket n = 22	CJ Socket n = 16	Quatro n = 17	Infinite Socket n = 19
Value	7.0 (0.5)	7.4 (0.6)	7.9 (0.4)	7.3 (0.5)

Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = 0.553, ANOVA

Population analysed: All participants who successfully wore the socket at home for three weeks are included. We also exclude baseline data from individuals who did not successfully complete at least one experimental socket.

Primary outcome: Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)

Time frame: After at least 3 weeks of prosthetic socket use. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Laminated Socket n = 22	CJ Socket n = 16	Quatro n = 17	Infinite Socket n = 19
Frustration Subscale	54.6 (41.5 to 67.8)	65.3 (49.6 to 80.9)	61.7 (46.6 to 76.8)	51.9 (38.0 to 65.9)
Perceived Response Subscale	85.1 (79.5 to 90.8)	90.0 (83.3 to 96.7)	89.9 (83.4 to 96.4)	87.3 (81.3 to 93.3)
Social Burden Subscale	70.0 (63.5 to 76.4)	82.1 (74.4 to 89.8)	79.8 (72.3 to 87.2)	77.9 (71.1 to 84.8)
Ambulation Subscale	52.4 (45.2 to 59.5)	66.6 (58.1 to 75.0)	66.9 (58.7 to 75.0)	57.1 (49.6 to 64.6)
Prosthesis Utility Subscale	59.3 (52.0 to 66.5)	72.6 (64.0 to 81.2)	72.2 (63.9 to 83.8)	62.9 (55.2 to 70.5)
Residual Limb Health Subscale	68.4 (62.1 to 74.7)	71.1 (63.6 to 78.6)	76.5 (69.3 to 83.8)	75.9 (69.2 to 82.6)
Appearance Subscale	65.3 (58.3 to 72.3)	76.7 (68.4 to 85.0)	73.3 (65.3 to 81.3)	62.1 (54.7 to 69.5)
Sounds Subscale	65.2 (55.6 to 74.9)	78.5 (67.1 to 89.9)	69.5 (58.4 to 80.5)	71.0 (61.8 to 82.2)

Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = 0.536, ANOVA
Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = 0.598, ANOVA
Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = 0.072, ANOVA

Population analysed: All participants who successfully completed at least one experimental condition

Primary outcome: Activities Specific Balance Confidence Scale

Time frame: After at least 3 weeks of prosthetic socket use. Mean (Standard Error). Unit: units on a scale

Measure	Laminated Socket n = 21	CJ Socket n = 16	Quatro n = 17	Infinite Socket n = 19
Value	68.7 (2.8)	70.4 (3.3)	67.8 (3.2)	68.8 (3.0)

Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = 0.95, ANOVA

Population analysed: All participants who successfully completed at least one experimental socket are included. One participants surveys for the laminated condition were lost in the mail.

Primary outcome: Mobility as Measured by the 10-meter Walk Test

Time frame: after at least 4 weeks of prosthetic socket use. Mean (Standard Error). Unit: m/s

Measure	Laminated Socket n = 22	CJ Socket n = 16	Quatro n = 18	Infinite Socket n = 16
Value	1.06 (.03)	1.09 (.03)	1.07 (.03)	1.08 (.03)

Laminated Socket vs CJ Socket vs Quatro vs Infinite Socket: p = .853, ANOVA

Population analysed: All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: over 4 weeks of prosthetic socket use, up to two months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laminated Socket	1 of 28 (3.6%)	2 of 28 (7.1%)	1 of 28
CJ Socket	0 of 25 (0%)	13 of 25 (52%)	0 of 25
Quatro	1 of 20 (5%)	7 of 20 (35%)	0 of 20
Infinite Socket	1 of 24 (4.2%)	10 of 24 (41.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Participant data will be deidentified for publication.

Related trials for Amputation

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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.

Deanna H Gates, PhD principal investigator

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laminated Socket, Quatro and Infinite Socket in people with Amputation and Amputation; Traumatic, Leg, Lower, run by University of Michigan at 2 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 4 inclusion and 5 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Socket Fit Comfort Score (time frame: After at least 3 weeks of prosthetic socket use). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04038580.

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 29 Sep 2025.