AmputationNCT06361966
Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets
A study testing 3d printed prosthetic socket in people with Amputation and Prosthesis User, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Amputation, Prosthesis User
- What is being tested?
- 3d printed prosthetic socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Jan 2022to 9 Jan 2023
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputation, current transtibial prosthetic users minimally capable of community ambulation (mobility grades K2 - K4) who have completed gait training, current users of a roll on elastomeric or silicone liner system, and aged 21 years old and above to be able to provide informed consent.
Who cannot join
- Functional status: patients with severe aphasia or neglect (inability to obey 1 step commands), communication disorders precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- Mobility status: patients who are non-community ambulators (mobility grade K1) or who have not completed gait training
- Active limb conditions: uncontrolled lower limb volume fluctuations, severe stump varus or valgus deformities and/or lower limb contractures of over 10 degrees, or with local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas, active arthritis or joint or limb pain.
- Reproductive age females should not be pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating User Satisfaction and Feasibility of a Remote-digital Model for 3d Scanning and Printing of Prosthetic Sockets for Patients With Transtibial Amputation: A Preliminary Clinical Trial
The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
The main question[s] it aims to answer are:
Read more
- To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
- To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
- To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.
Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.
Read the detailed description
The visit schedule for the study is as follows:
- Visit 1 (Week 0): Attain consent and initiate casting and scanning process for 1 laminate and 1 3D printed transtibial socket
- Visit 2 (Week 3): Fitting and adjustment of first prosthetic socket (either 3D printed or laminate socket). Subjects to rate comfort of first socket.
- Visit 3 (Week 5): Follow-up on any required device adjustments/ troubleshooting to first socket.
- Visit 4 (Week 7): Evaluation of user satisfaction with first socket. Subjects to fill up survey on first socket. Fitting of other socket design (second socket). Subjects to rate comfort of second socket.
- Visit 5 (Week 9): Follow-up on any required device adjustments/ troubleshooting to second socket.
- Visit 6 (Week 11): Evaluation of user satisfaction with second socket. Subjects to fill up survey on second socket and select their preferred socket. Fitting of patient's preferred socket to prosthesis.
- Conditions
- Amputation, Prosthesis User
- Being tested
- 3d printed prosthetic socket
- Keywords
- transtibial amputation, transtibial prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed prosthetic socketDevice
3d printed prosthetic socket produced through multi-jet fusion (MJF)
| Study group | Role | What they receive |
|---|---|---|
| Laminate socket | Active comparator | control intervention as standard treatment for transtibial amputees requiring a lower limb prosthesis Receives: Device: 3d printed prosthetic socket |
| 3d printed socket | Experimental | trial intervention for transtibial amputees requiring a lower limb prosthesis Receives: Device: 3d printed prosthetic socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis Evaluation Questionnaire
Subscales of Utility, Appearance, Sounds and Residual Limb Health, and an individual satisfaction question
Measured: after 4 weeks of socket use
Socket Comfort Score
Self-reported socket comfort is rated from 0 - 10, where 0 is the most uncomfortable socket imaginable and 10 the most comfortable.
Measured: at initial socket fitting and 4 weeks post-fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start11 Jan 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Prosfit Technologies JSC, Centre for Allied Health and Pharmacy Excellence (CAPE)
- Responsible party
- Principal investigator, Tabitha Quake, Tan Tock Seng Hospital
- Investigators
- Tabitha Quake, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361966
- Sponsor's protocol ID
- 2021/00638
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating User Satisfaction and Feasibility of a Remote-digital Model for 3d Scanning and Printing of Prosthetic Sockets for Patients With Transtibial Amputation: A Preliminary Clinical Trial
- ClinicalTrials.gov ID
- NCT06361966
- Acronym / sponsor ID
- 2021/00638
- Conditions
- Amputation, Prosthesis User
- Keywords
- transtibial amputation, transtibial prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Prosfit Technologies JSC, Centre for Allied Health and Pharmacy Excellence (CAPE)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 12 Apr 2024 (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 goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
The main question[s] it aims to answer are:
- To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
- To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
- To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.
Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.
Detailed description
The visit schedule for the study is as follows:
- Visit 1 (Week 0): Attain consent and initiate casting and scanning process for 1 laminate and 1 3D printed transtibial socket
- Visit 2 (Week 3): Fitting and adjustment of first prosthetic socket (either 3D printed or laminate socket). Subjects to rate comfort of first socket.
- Visit 3 (Week 5): Follow-up on any required device adjustments/ troubleshooting to first socket.
- Visit 4 (Week 7): Evaluation of user satisfaction with first socket. Subjects to fill up survey on first socket. Fitting of other socket design (second socket). Subjects to rate comfort of second socket.
- Visit 5 (Week 9): Follow-up on any required device adjustments/ troubleshooting to second socket.
- Visit 6 (Week 11): Evaluation of user satisfaction with second socket. Subjects to fill up survey on second socket and select their preferred socket. Fitting of patient's preferred socket to prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminate socket | Active comparator | Device: 3d printed prosthetic socketcontrol intervention as standard treatment for transtibial amputees requiring a lower limb prosthesis |
| 3d printed socket | Experimental | Device: 3d printed prosthetic sockettrial intervention for transtibial amputees requiring a lower limb prosthesis |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral transtibial amputation, current transtibial prosthetic users minimally capable of community ambulation (mobility grades K2 - K4) who have completed gait training, current users of a roll on elastomeric or silicone liner system, and aged 21 years old and above to be able to provide informed consent.
Key exclusion criteria (4 listed)
- Functional status: patients with severe aphasia or neglect (inability to obey 1 step commands), communication disorders precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- Mobility status: patients who are non-community ambulators (mobility grade K1) or who have not completed gait training
- Active limb conditions: uncontrolled lower limb volume fluctuations, severe stump varus or valgus deformities and/or lower limb contractures of over 10 degrees, or with local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas, active arthritis or joint or limb pain.
- Reproductive age females should not be pregnant during the study.
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 |
|---|---|---|
| 3d printed prosthetic socket3d printed prosthetic socket produced through multi-jet fusion (MJF) | Device | 3d printed socket, Laminate socket |
Primary outcome
Prosthesis Evaluation Questionnaire
Time frame: after 4 weeks of socket use
Subscales of Utility, Appearance, Sounds and Residual Limb Health, and an individual satisfaction question
Socket Comfort Score
Time frame: at initial socket fitting and 4 weeks post-fitting
Self-reported socket comfort is rated from 0 - 10, where 0 is the most uncomfortable socket imaginable and 10 the most comfortable.
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 12 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Amputation
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Prosthetic Socket Fit Testing System
Amputation
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.
Tabitha Quake principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed prosthetic socket in people with Amputation and Prosthesis User, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 1 inclusion and 4 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Prosthesis Evaluation Questionnaire (time frame: after 4 weeks of socket use). The study lists 2 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 12 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.