Clinical Evaluation of Direct Manufactured Prosthetic Sockets

• 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: Ohio Willow Wood
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Entire Study Population
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
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

Outcome Measures

1. Primary Outcome

Title	Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
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

Outcome Measure Data

Analysis Population Description

Per protocol analysis including all consented participants

Arm/Group Title	Traditional Socket	Direct Manufactured Socket
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)

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
Description	Number of participants indicating socket preference after initial fitting of both socket interventions
Time Frame	Within the first 4-6 hours

Outcome Measure Data

Analysis Population Description

Total number of participants completing period for both study interventions.

Arm/Group Title	Socket Preference
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
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

Outcome Measure Data

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
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

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Traditional Socket	Direct Manufactured Socket
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	--/--	--/--
Serious Adverse Events
	Traditional Socket	Direct Manufactured Socket
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/10 (0.00%)	0/10 (0.00%)
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%)

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.

More Information

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

• Name/Title: Applied Research Engineer
• Organization: The Ohio Willow Wood Company
• Phone: 740-869-3377
• EMail: mariag@owwco.com

• 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