Clinical trial NCT01155024: Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Official title: Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amputation
Keywords: Lower extremity amputation
Prosthetic Sockets
Direct Manufactured (DM)
Lead sponsor: Ohio Willow Wood
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2010-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
timeFrame: Within the first 4-6 hrs
Secondary outcomes:
measure: Participant Socket Preference After Initial Fitting
timeFrame: Within the first 4-6 hours
measure: Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket
timeFrame: 3 months
Other outcomes:
Locations:
city: Mt. Sterling
country: United States
facility: Ohio Willow Wood
state: Ohio
Study officials:
affiliation: Ohio Willow Wood
name: James Colvin, M.S.
role: PRINCIPAL_INVESTIGATOR
References: