Amputation
Conditions
Keywords
Lower extremity amputation, Prosthetic Sockets, Direct Manufactured (DM)
Brief 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.
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).
Interventions
DEVICETraditional fabricated prosthetic socket
A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.
DEVICEDirect manufactured (DM) prosthetic socket
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)
Sponsors
United States Department of Defense
Ohio Willow Wood
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* An inability to give informed consent * Presence of any sores, lacerations or rashes on the residual limb * Impaired contra lateral foot * Poor distal sensation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Socket Preference After Initial Fitting | Within the first 4-6 hours | Number of participants indicating socket preference after initial fitting of both socket interventions |
| Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket | 3 months | 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 |
Countries
United States
Participant flow
Recruitment details
Participants recruited between March 2011 and June 2011
Pre-assignment details
10 participants recruited; 10 screened, 0 excluded
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Direct Manufactured Socket 3 Month Trial | Experienced inferior suspension system | 0 | 2 |
| Direct Manufactured Socket 3 Month Trial | Lost to Follow-up | 0 | 2 |
| Direct Manufactured Socket 3 Month Trial | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 53.2 years STANDARD_DEVIATION 11.9 |
| Number of years participant has worn a Prosthesis | 13.4 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 106 kg STANDARD_DEVIATION 24.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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)
Time frame: Within the first 4-6 hrs
Population: Per protocol analysis including all consented participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Socket | Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting | 9 score on scale | Standard Deviation 0.82 |
| Direct Manufactured Socket | Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting | 8.7 score on scale | Standard Deviation 0.82 |
Comparison: Alpha level of 0.05p-value: >0.4t-test, 2 sided
Secondary
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
Time frame: 3 months
Population: Total number of participants completing the period (3 months usage of direct manufactured socket) and participants classified as 'Withdrawal by participant'. Analysis does not include participants who prematurely withdrew for reasons unrelated to the direct manufactured socket intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Traditional Socket | Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket | Preferred Traditional Socket | 2 participants |
| Traditional Socket | Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket | Preferred Direct Manufactured Socket | 4 participants |
| Traditional Socket | Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket | No Preference/Difference | 0 participants |
Secondary
Participant Socket Preference After Initial Fitting
Number of participants indicating socket preference after initial fitting of both socket interventions
Time frame: Within the first 4-6 hours
Population: Total number of participants completing period for both study interventions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Traditional Socket | Participant Socket Preference After Initial Fitting | Preferred Traditional Socket | 2 participants |
| Traditional Socket | Participant Socket Preference After Initial Fitting | Preferred Direct Manufactured Socket | 0 participants |
| Traditional Socket | Participant Socket Preference After Initial Fitting | No Preference/Difference | 8 participants |