Trial Outcomes & Findings for To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees (NCT NCT05012683)

Results Overview

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Day 0: no prosthesis (pre-fitting)

Results posted on

2025-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	No Prosthesis, Then Prosthesis Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
No Prosthesis (Day 0) STARTED	11
No Prosthesis (Day 0) COMPLETED	11
No Prosthesis (Day 0) NOT COMPLETED	0
Prosthesis (Day 0) STARTED	11
Prosthesis (Day 0) COMPLETED	11
Prosthesis (Day 0) NOT COMPLETED	0
Prosthesis (Day 30) STARTED	11
Prosthesis (Day 30) COMPLETED	11
Prosthesis (Day 30) NOT COMPLETED	0
Prosthesis (Day 60) STARTED	11
Prosthesis (Day 60) COMPLETED	11
Prosthesis (Day 60) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting Point Partial: Patient is fit with Point Partial partial finger prosthetic system
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	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0: no prosthesis (pre-fitting)

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)	90.3 score on a scale Standard Deviation 5.1

PRIMARY outcome

Timeframe: Day 0: no prosthesis (pre-fitting)

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Disability of the Arm, Shoulder and Hand (DASH)	34.5 score on a scale Standard Deviation 17.7

PRIMARY outcome

Timeframe: Day 0: no prosthesis (pre-fitting)

Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
EuroQol-5 Dimension (EQ-5D-5L)	80.6 score on a scale Standard Deviation 12.1

PRIMARY outcome

Timeframe: Day 0: with prosthesis, immediately post-fitting

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)	88.4 score on a scale Standard Deviation 7.9

PRIMARY outcome

Timeframe: Day 0: with prosthesis, immediately post-fitting

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Disability of the Arm, Shoulder and Hand (DASH)	28.3 score on a scale Standard Deviation 16.3

PRIMARY outcome

Timeframe: Day 0: with prosthesis, immediately post-fitting

Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
EuroQol-5 Dimension (EQ-5D-5L)	80.7 score on a scale Standard Deviation 11.5

PRIMARY outcome

Timeframe: ~Day 30: with prosthesis, 30 days post-fitting

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)	91.7 score on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: ~Day 30: with prosthesis, 30 days post-fitting

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Disability of the Arm, Shoulder and Hand (DASH)	26.1 score on a scale Standard Deviation 12.5

PRIMARY outcome

Timeframe: ~Day 30: with prosthesis, 30 days post-fitting

Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
EuroQol-5 Dimension (EQ-5D-5L)	81.9 score on a scale Standard Deviation 9.2

PRIMARY outcome

Timeframe: ~Day 60: with prosthesis, 60 days post-fitting

Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)	92.0 score on a scale Standard Deviation 7.3

PRIMARY outcome

Timeframe: ~Day 60: with prosthesis, 60 days post-fitting

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
Disability of the Arm, Shoulder and Hand (DASH)	19.0 score on a scale Standard Deviation 9.5

PRIMARY outcome

Timeframe: ~Day 60: with prosthesis, 60 days post-fitting

Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	No Prosthesis, Then Prosthesis n=11 Participants Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a Point Partial partial finger prosthetic system and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.
EuroQol-5 Dimension (EQ-5D-5L)	81.4 score on a scale Standard Deviation 16.8

Adverse Events

No Prosthesis, Then Prosthesis

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

Director of Clinical Research

Point Designs

Phone: 7206004753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place