AmputationPhase 2NCT00061217
Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design
A Phase 2 study testing Unrectified prosthetic socket and Rectified prosthetic socket in people with Amputation, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- Unrectified prosthetic socket and Rectified prosthetic socket
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2005
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputation
- Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
- Continuously worn a prosthesis for at least 1 year prior to study entry
- Scheduled for a new prosthesis
- Independent ambulation
- No acute health problems
Who cannot join
- Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
- Requires gel inserts, additional ply socks, or other atypical fitting components or methods
- Health status that prohibits patient from performing graded exercise test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rectified and Unrectified Amputee Sockets
People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.
Read the detailed description
The traditional assumption when fabricating a transtibial amputee (TTA) socket is that the residual limb is not homogeneous in its ability to tolerate load. As a result, prosthetic sockets are currently fabricated by modifying a positive mold to account for this non-homogeneity; these are called rectified sockets. Unrectified sockets retain the shape of the residual limb, except for a distal end pad. Unrectified sockets use an alginate gel method of fabricating that is simpler and less time consuming than the method used to fabricate rectified sockets. This study will compare patient satisfaction and function with rectified and unrectified sockets.
Participants in this study will be randomized to either a recitified socket group or an unrectified socket group. Participants will wear the socket for a minimum of 4 weeks. Participants will then fill out a Prosthesis Evaluation Questionnaire (PEQ). The PEQ quantifies patient satisfaction by evaluating nine validated scales. Functional measures of energy expenditure, kinematics, and ground reaction forces during gait will also be collected. After 4 weeks, participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket. At the end of 4 weeks with the new socket, participants will once again fill out the PEQ and undergo functional assessment. At the end of study participation, each participant will freely choose the socket they wish to have in their final prosthesis.
Thus far, 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks. Results indicated no differences between sockets for gait speed and timing, gait kinematics and kinetics, gait energy expenditure, and Rate of Perceived Exertion (RPE). There were also no differences in the Prosthetic Evaluation Questionnaire. Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket.
- Conditions
- Amputation
- Being tested
- Unrectified prosthetic socket, Rectified prosthetic socket
- Keywords
- Transtibial amputees, Rectified sockets, Unrectified sockets, Gait, Energy expenditure, Prosthetic evaluation questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unrectified prosthetic socketDevice
Rectified prosthetic socketDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
socket selection
PEQ
gait speed
Secondary outcomes (3)
gait kinematics
gait kinetics
energy consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2003 (estimated)
- Study startApr 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 59 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack R. Engsberg, Ph.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061217
- Sponsor's protocol ID
- R01HD038919-02
- Status last verified
- Oct 2004
- First submitted
- 22 May 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Engsberg JR, Sprouse SW, Uhrich ML, Ziegler BR, Luitjohan FD. Comparison of Rectified and Unrectified Sockets for Transtibial Amputees. J Prosthet Orthot. 2008;18(1):1-7. doi: 10.1097/00008526-200601000-00002.
PubMed 18776945
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rectified and Unrectified Amputee Sockets
- ClinicalTrials.gov ID
- NCT00061217
- Acronym / sponsor ID
- R01HD038919-02
- Conditions
- Amputation
- Keywords
- Transtibial amputees, Rectified sockets, Unrectified sockets, Gait, Energy expenditure, Prosthetic evaluation questionnaire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Apr 2001
- Study completion
- Mar 2005
- First posted
- 23 May 2003 (estimated)
- 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.
People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.
Detailed description
The traditional assumption when fabricating a transtibial amputee (TTA) socket is that the residual limb is not homogeneous in its ability to tolerate load. As a result, prosthetic sockets are currently fabricated by modifying a positive mold to account for this non-homogeneity; these are called rectified sockets. Unrectified sockets retain the shape of the residual limb, except for a distal end pad. Unrectified sockets use an alginate gel method of fabricating that is simpler and less time consuming than the method used to fabricate rectified sockets. This study will compare patient satisfaction and function with rectified and unrectified sockets.
Participants in this study will be randomized to either a recitified socket group or an unrectified socket group. Participants will wear the socket for a minimum of 4 weeks. Participants will then fill out a Prosthesis Evaluation Questionnaire (PEQ). The PEQ quantifies patient satisfaction by evaluating nine validated scales. Functional measures of energy expenditure, kinematics, and ground reaction forces during gait will also be collected. After 4 weeks, participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket. At the end of 4 weeks with the new socket, participants will once again fill out the PEQ and undergo functional assessment. At the end of study participation, each participant will freely choose the socket they wish to have in their final prosthesis.
Thus far, 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks. Results indicated no differences between sockets for gait speed and timing, gait kinematics and kinetics, gait energy expenditure, and Rate of Perceived Exertion (RPE). There were also no differences in the Prosthetic Evaluation Questionnaire. Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral transtibial amputation
- Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
- Continuously worn a prosthesis for at least 1 year prior to study entry
- Scheduled for a new prosthesis
- Independent ambulation
Key exclusion criteria (3 listed)
- Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
- Requires gel inserts, additional ply socks, or other atypical fitting components or methods
- Health status that prohibits patient from performing graded exercise test
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 |
|---|---|---|
| Unrectified prosthetic socket | Device | – |
| Rectified prosthetic socket | Device | – |
Primary outcome
socket selection
PEQ
gait speed
3 secondary outcomes
gait kinematics
gait kinetics
energy consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 18776945Engsberg JR, Sprouse SW, Uhrich ML, Ziegler BR, Luitjohan FD. Comparison of Rectified and Unrectified Sockets for Transtibial Amputees. J Prosthet Orthot. 2008;18(1):1-7. doi: 10.1097/00008526-200601000-00002.
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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.
Jack R. Engsberg, Ph.D. principal investigator
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 Unrectified prosthetic socket and Rectified prosthetic socket in people with Amputation, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
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 selection. The study lists 3 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 NCT00061217, which also lists 1 linked publication.
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 24 Jun 2005.