AmputationPhase 2NCT01155024
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
A Phase 2 study testing Traditional fabricated prosthetic socket and Direct manufactured (DM) prosthetic socket in people with Amputation, run by Ohio Willow Wood at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Traditional fabricated prosthetic socket and Direct manufactured (DM) prosthetic socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 2
- 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
- Be a lower extremity amputee longer than one year
- Be a consenting adult (at least 18 years or age or older)
- Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
- Currently using a liner with prosthesis
- Be available during regular business hours for appointments
Who cannot join
- An inability to give informed consent
- Presence of any sores, lacerations or rashes on the residual limb
- Impaired contra lateral foot
- Poor distal sensation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
Read the detailed description
Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic \& Prosthetic (O\&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.
The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.
With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.
While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.
The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.
This study will compare two fabrication techniques for diagnostic and definitive sockets: manually fabricated (positive model technique) and direct manufactured (experimental).
- Conditions
- Amputation
- Being tested
- Traditional fabricated prosthetic socket, Direct manufactured (DM) prosthetic socket
- Keywords
- Lower extremity amputation, Prosthetic Sockets, Direct Manufactured (DM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional fabricated prosthetic socketDevice
Also called Rectified prosthetic socket
A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.
Direct manufactured (DM) prosthetic socketDevice
A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)
| Study group | Role | What they receive |
|---|---|---|
| Traditional Socket First, then DM Socket | Other | Initial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period Receives: Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket |
| DM Socket First, then Traditional Socket | Other | Initial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period Receives: Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)
Measured: Within the first 4-6 hrs
Secondary outcomes (2)
Participant Socket Preference After Initial Fitting
Number of participants indicating socket preference after initial fitting of both socket interventions
Measured: Within the first 4-6 hours
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket
Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio Willow Wood
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- James Colvin, M.S., Principal investigator, Ohio Willow Wood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155024
- Sponsor's protocol ID
- W81XWH-08-10700-V1
- Status last verified
- Dec 2011
- First submitted
- 29 Jun 2010
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Direct Manufactured Prosthetic Sockets
- ClinicalTrials.gov ID
- NCT01155024
- Acronym / sponsor ID
- W81XWH-08-10700-V1
- Conditions
- Amputation
- Keywords
- Lower extremity amputation, Prosthetic Sockets, Direct Manufactured (DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio Willow WoodIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 11 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
Detailed description
Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic \& Prosthetic (O\&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.
The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.
With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.
While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.
The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.
This study will compare two fabrication techniques for diagnostic and definitive sockets: manually fabricated (positive model technique) and direct manufactured (experimental).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Socket First, then DM Socket | Other | Device: Traditional fabricated prosthetic socket, Device: Direct manufactured (DM) prosthetic socketInitial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period |
| DM Socket First, then Traditional Socket | Other | Device: Traditional fabricated prosthetic socket, Device: Direct manufactured (DM) prosthetic socketInitial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a lower extremity amputee longer than one year
- Be a consenting adult (at least 18 years or age or older)
- Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
- Currently using a liner with prosthesis
- Be available during regular business hours for appointments
Key exclusion criteria (4 listed)
- An inability to give informed consent
- Presence of any sores, lacerations or rashes on the residual limb
- Impaired contra lateral foot
- Poor distal sensation
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 |
|---|---|---|
| Traditional fabricated prosthetic socketAlso: Rectified prosthetic socketA prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison. | Device | DM Socket First, then Traditional Socket, Traditional Socket First, then DM Socket |
| Direct manufactured (DM) prosthetic socketA prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months) | Device | DM Socket First, then Traditional Socket, Traditional Socket First, then DM Socket |
Primary outcome
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
Time frame: Within the first 4-6 hrs
The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)
2 secondary outcomes
Participant Socket Preference After Initial Fitting
Time frame: Within the first 4-6 hours
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Colvin, M.S. principal investigator
Ohio Willow Wood
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional fabricated prosthetic socket and Direct manufactured (DM) prosthetic socket in people with Amputation, run by Ohio Willow Wood at 1 site 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 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 11 Jan 2012. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2012). 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?
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting (time frame: Within the first 4-6 hrs). 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 11 Jan 2012.