An interventional study of Point Partial in Amputation; Traumatic, Hand, sponsored by Point Designs. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Point Designs · Not applicable, Interventional, and Device feasibility
The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 5 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Point Designs is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient is temporarily fit with Point Partial partial finger prosthetic system
Device: 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
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.
Time frame: Day 1 (8 hours)
VAL-2: Unilateral Function Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-3.1: System Robustness Validation Test With 25 lb Bag
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.
Time frame: Day 1 (10 minutes)
VAL-3.2: Robustness Validation Test With Hammer
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.
Time frame: Day 1 (10 minutes)
VAL-4: Object Release Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-5: Position Function Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-6: Extension Function Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-7: Grip Functions Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-8: Fine Motor Function Validation Test
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.
Time frame: Day 1 (10 minutes)
VAL-9: Overall Function & Robustness Validation Test
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.
Time frame: Day 1 (8 hours)
| Milestone | Prosthesis |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-1: System Comfort Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-2: Unilateral Function Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-3.1: System Robustness Validation Test With 25 lb Bag | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-3.2: Robustness Validation Test With Hammer | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-4: Object Release Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-5: Position Function Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-6: Extension Function Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-7: Grip Functions Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-8: Fine Motor Function Validation Test | 100 |
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.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-9: Overall Function & Robustness Validation Test | 100 |
Collected over an average of 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prosthesis | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Prosthesis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Prosthesis |
|---|---|
| Female | 1 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Prosthesis |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Prosthesis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in Dec 2022, 25 months.
Results were first posted in Nov 2024, 1 year 10 months after primary completion.
Of 46 interventional studies with no phase under Amputation, Traumatic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's 25 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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