Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional fabricated prosthetic socket | Device | A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within the first 4-6 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Socket Preference After Initial Fitting | Number of participants indicating socket preference after initial fitting of both socket interventions | Within the first 4-6 hours |
| Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Colvin, M.S. | Ohio Willow Wood | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Willow Wood | Mount Sterling | Ohio | 43143 | United States |
10 participants recruited; 10 screened, 0 excluded
Participants recruited between March 2011 and June 2011
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Socket | Initial fitting of a traditional diagnostic prosthetic socket |
| FG001 | Direct Manufactured Socket | Initial fitting of a direct manufactured prosthetic socket |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Socket Intervention Fitting |
| |||||||||||||
| Second Socket Intervention Fitting |
| |||||||||||||
| Direct Manufactured Socket 3 Month Trial |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Per protocol analysis including all consented participants | Posted | Mean | Standard Deviation | score on scale | Within the first 4-6 hrs |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Socket | Initial fitting of a traditional diagnostic prosthetic socket |
Not provided
Not provided
Early termination by four participants for reasons unrelated to the interventions lead to smaller numbers completing the 3 month trial period for the direct manufactured socket.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Applied Research Engineer | The Ohio Willow Wood Company | 740-869-3377 | mariag@owwco.com |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Direct manufactured (DM) prosthetic socket | Device | 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) |
|
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 |
| 3 months |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Number of years participant has worn a Prosthesis | Total number of years the participant has worn a lower limb prosthesis | Mean | Standard Deviation | years |
|
|
|
|
| Secondary | Participant Socket Preference After Initial Fitting | Number of participants indicating socket preference after initial fitting of both socket interventions | Total number of participants completing period for both study interventions. | Posted | Number | participants | Within the first 4-6 hours |
|
|
|
| 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 | 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. | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Direct Manufactured Socket | Initial fitting of a direct manufactured prosthetic socket | 0 | 10 | 0 | 10 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|