Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Status Completed

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Amputation

Clinical Trial Details

NCT number	NCT01155024
Study type	Interventional
Source	Ohio Willow Wood
Contact
Status	Completed
Phase	Phase 2
Start date	September 2010
Completion date	September 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03947450` - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees	Phase 2
Completed	`NCT04924036` - Qbrexza Cloths for Hyperhidrosis of Amputation Sites	Phase 2
Recruiting	`NCT04839497` - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.	Phase 2
Recruiting	`NCT04212299` - Transfemoral Socket Design and Muscle Function	N/A
Completed	`NCT03733054` - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed	`NCT03651830` - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations	N/A
Recruiting	`NCT04725006` - Sensory Responses to Dorsal Root Stimulation	N/A
Not yet recruiting	`NCT06007885` - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.	N/A
Not yet recruiting	`NCT04936789` - Clinical Feasibility of the IMES Transradial Prosthesis	N/A
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A
Terminated	`NCT00778856` - Hand Transplantation for the Reconstruction of Below the Elbow Amputations	N/A
Recruiting	`NCT00388752` - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation	Phase 1
Active, not recruiting	`NCT03374319` - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations	N/A
Completed	`NCT05542901` - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees	N/A
Completed	`NCT05161364` - Kinetic Analysis Due to Foot Dysfunction
Recruiting	`NCT06194838` - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees	N/A
Completed	`NCT03570788` - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed	`NCT05778799` - Physical Activity and Sports for People With Special Needs
Recruiting	`NCT04804150` - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System	N/A
Terminated	`NCT03259386` - Movement and Sensation for Advanced Prosthetic Hands

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.