Clinical Evaluation of Direct Manufactured Prosthetic Sockets

NCT01155024 | Completed Phase 2 Results

• 1 other identifier: W81XWH-08-10700-V1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Lower extremity amputation; Prosthetic Sockets; Direct Manufactured (DM)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Participant Socket Preference After Initial Fitting

  Within the first 4-6 hours

• Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket

  3 months

Study Arms (2)

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

Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket

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

Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket

Interventions

Traditional fabricated prosthetic socket DEVICE

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Also known as: Rectified prosthetic socket

DM Socket First, then Traditional Socket; Traditional Socket First, then DM Socket

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)

DM Socket First, then Traditional Socket; Traditional Socket First, then DM Socket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• An inability to give informed consent
• Presence of any sores, lacerations or rashes on the residual limb
• Impaired contra lateral foot
• Poor distal sensation

Sponsors & Collaborators

• Ohio Willow Wood: lead
• United States Department of Defense: collaborator

Study Sites (1)

Ohio Willow Wood

Mount Sterling, Ohio, 43143, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Applied Research Engineer
• Organization: The Ohio Willow Wood Company

mariag@owwco.com

740-869-3377

Study Officials

• James Colvin, M.S.

  Ohio Willow Wood

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 11, 2012
• Results First Posted: January 11, 2012

Record last verified: 2011-12

Locations

US (1)