Trial Outcomes & Findings for Clinical Evaluation of Direct Manufactured Prosthetic Sockets (NCT NCT01155024)

Last Updated: 2012-01-11

Results Overview

The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Within the first 4-6 hrs

Results posted on

2012-01-11

Participant Flow

Participants recruited between March 2011 and June 2011

10 participants recruited; 10 screened, 0 excluded

Participant milestones

Participant milestones
Measure	Traditional Socket Initial fitting of a traditional diagnostic prosthetic socket	Direct Manufactured Socket Initial fitting of a direct manufactured prosthetic socket
First Socket Intervention Fitting STARTED	5	5
First Socket Intervention Fitting COMPLETED	5	5
First Socket Intervention Fitting NOT COMPLETED	0	0
Second Socket Intervention Fitting STARTED	5	5
Second Socket Intervention Fitting COMPLETED	5	5
Second Socket Intervention Fitting NOT COMPLETED	0	0
Direct Manufactured Socket 3 Month Trial STARTED	0	10
Direct Manufactured Socket 3 Month Trial COMPLETED	0	4
Direct Manufactured Socket 3 Month Trial NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Traditional Socket Initial fitting of a traditional diagnostic prosthetic socket	Direct Manufactured Socket Initial fitting of a direct manufactured prosthetic socket
Direct Manufactured Socket 3 Month Trial Experienced inferior suspension system	0	2
Direct Manufactured Socket 3 Month Trial Lost to Follow-up	0	2
Direct Manufactured Socket 3 Month Trial Withdrawal by Subject	0	2

Baseline Characteristics

Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=10 Participants Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	53.2 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Weight	106 kg STANDARD_DEVIATION 24.7 • n=5 Participants
Number of years participant has worn a Prosthesis	13.4 years STANDARD_DEVIATION 9.9 • n=5 Participants

PRIMARY outcome

Timeframe: Within the first 4-6 hrs

Population: Per protocol analysis including all consented participants

The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)

Outcome measures

Outcome measures
Measure	Traditional Socket n=10 Participants Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.	Direct Manufactured Socket n=10 Participants Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting	9 score on scale Standard Deviation 0.82	8.7 score on scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Within the first 4-6 hours

Population: Total number of participants completing period for both study interventions.

Number of participants indicating socket preference after initial fitting of both socket interventions

Outcome measures

Outcome measures
Measure	Traditional Socket n=10 Participants Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.	Direct Manufactured Socket Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
Participant Socket Preference After Initial Fitting Preferred Traditional Socket	2 participants	—
Participant Socket Preference After Initial Fitting Preferred Direct Manufactured Socket	0 participants	—
Participant Socket Preference After Initial Fitting No Preference/Difference	8 participants	—

SECONDARY outcome

Timeframe: 3 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Traditional Socket n=6 Participants Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.	Direct Manufactured Socket Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket Preferred Traditional Socket	2 participants	—
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket Preferred Direct Manufactured Socket	4 participants	—
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket No Preference/Difference	0 participants	—

Adverse Events

Traditional Socket

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Direct Manufactured Socket

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Applied Research Engineer

The Ohio Willow Wood Company

Phone: 740-869-3377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place