Trial Outcomes & Findings for Validation of Point Partial User Needs With Partial Finger Amputees (NCT NCT05012657)
NCT ID: NCT05012657
Last Updated: 2024-11-08
Results Overview
User wears Point Partial(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
COMPLETED
NA
5 participants
Day 1 (8 hours)
2024-11-08
Participant Flow
Participant milestones
| Measure |
Prosthesis
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of Point Partial User Needs With Partial Finger Amputees
Baseline characteristics by cohort
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (8 hours)User wears Point Partial(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-1: System Comfort Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-2: Unilateral Function Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-3.1: System Robustness Validation Test With 25 lb Bag
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-3.2: Robustness Validation Test With Hammer
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-4: Object Release Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User positions Point Partial(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-5: Position Function Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-6: Extension Function Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-7: Grip Functions Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (10 minutes)User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-8: Fine Motor Function Validation Test
|
100 % of participants who Passed test
|
PRIMARY outcome
Timeframe: Day 1 (8 hours)User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Outcome measures
| Measure |
Prosthesis
n=5 Participants
Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
|
|---|---|
|
VAL-9: Overall Function & Robustness Validation Test
|
100 % of participants who Passed test
|
Adverse Events
Prosthesis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place