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Clinical Evaluation of Direct Manufactured Prosthetic Sockets

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ClinicalTrials.gov Identifier: NCT01155024
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ohio Willow Wood

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Amputation
Interventions Device: Traditional fabricated prosthetic socket
Device: Direct manufactured (DM) prosthetic socket
Enrollment 10
Recruitment Details Participants recruited between March 2011 and June 2011
Pre-assignment Details 10 participants recruited; 10 screened, 0 excluded
Arm/Group Title Traditional Socket Direct Manufactured Socket
Hide Arm/Group Description Initial fitting of a traditional diagnostic prosthetic socket Initial fitting of a direct manufactured prosthetic socket
Period Title: First Socket Intervention Fitting
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Second Socket Intervention Fitting
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Direct Manufactured Socket 3 Month Trial
Started 0 10
Completed 0 4
Not Completed 0 6
Reason Not Completed
Experienced inferior suspension system             0             2
Lost to Follow-up             0             2
Withdrawal by Subject             0             2
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  90.0%
>=65 years
1
  10.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
53.2  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants
106  (24.7)
Number of years participant has worn a Prosthesis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
13.4  (9.9)
[1]
Measure Description: Total number of years the participant has worn a lower limb prosthesis
1.Primary Outcome
Title Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis including all consented participants
Arm/Group Title Traditional Socket Direct Manufactured Socket
Hide Arm/Group Description:
Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on scale
9  (0.82) 8.7  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Traditional Socket, Direct Manufactured Socket
Comments Alpha level of 0.05
Type of Statistical Test Non-Inferiority or Equivalence
Comments 10 participants required to detect one value change in rating for the SCS scale, with 80% power.
Statistical Test of Hypothesis P-Value >0.4
Comments Two-Sided
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Participant Socket Preference After Initial Fitting
Hide Description Number of participants indicating socket preference after initial fitting of both socket interventions
Time Frame Within the first 4-6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants completing period for both study interventions.
Arm/Group Title Socket Preference
Hide Arm/Group Description:
Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Preferred Traditional Socket 2
Preferred Direct Manufactured Socket 0
No Preference/Difference 8
3.Secondary Outcome
Title Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Socket Preference
Hide Arm/Group Description:
Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Preferred Traditional Socket 2
Preferred Direct Manufactured Socket 4
No Preference/Difference 0
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Traditional Socket Direct Manufactured Socket
Hide Arm/Group Description Initial fitting of a traditional diagnostic prosthetic socket Initial fitting of a direct manufactured prosthetic socket
All-Cause Mortality
Traditional Socket Direct Manufactured Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Traditional Socket Direct Manufactured Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Traditional Socket Direct Manufactured Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Applied Research Engineer
Organization: The Ohio Willow Wood Company
Phone: 740-869-3377
EMail: mariag@owwco.com
Layout table for additonal information
Responsible Party: Ohio Willow Wood
ClinicalTrials.gov Identifier: NCT01155024    
Other Study ID Numbers: W81XWH-08-10700-V1
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: October 26, 2011
Results First Posted: January 11, 2012
Last Update Posted: January 11, 2012