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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Arm Dynamics | INDUSTRY |
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This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment. The use of the Point Partial outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Prosthesis, then Prosthesis | Experimental | Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a prosthesis and outcome measurements will be performed at 3 different points in time: immediately post-fitting, ~30 days post-fitting, and ~60 days post-fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point Partial | Device | Patient is fit with Point Partial partial finger prosthetic system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | Day 0: no prosthesis (pre-fitting) |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | Day 0: no prosthesis (pre-fitting) |
| EuroQol-5 Dimension (EQ-5D-5L) | 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. | Day 0: no prosthesis (pre-fitting) |
| Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Point Designs | Lafayette | Colorado | 80026 | United States | ||
| Arm Dynamics |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No Prosthesis (Day 0) |
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| Prosthesis (Day 0) |
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| Prosthesis (Day 30) |
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| Prosthesis (Day 60) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Prosthesis, Then Prosthesis | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: no prosthesis (pre-fitting) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Point Designs | 7206004753 | research@pointdesignsllc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2019 | Dec 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2019 | Dec 28, 2023 | SAP_001.pdf |
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| Day 0: with prosthesis, immediately post-fitting |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | Day 0: with prosthesis, immediately post-fitting |
| EuroQol-5 Dimension (EQ-5D-5L) | 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. | Day 0: with prosthesis, immediately post-fitting |
| Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | ~Day 30: with prosthesis, 30 days post-fitting |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | ~Day 30: with prosthesis, 30 days post-fitting |
| EuroQol-5 Dimension (EQ-5D-5L) | 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. | ~Day 30: with prosthesis, 30 days post-fitting |
| Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | ~Day 60: with prosthesis, 60 days post-fitting |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. | ~Day 60: with prosthesis, 60 days post-fitting |
| EuroQol-5 Dimension (EQ-5D-5L) | 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. | ~Day 60: with prosthesis, 60 days post-fitting |
| Overland Park |
| Kansas |
| 66209 |
| United States |
| Arm Dynamics | Maple Grove | Minnesota | 55369 | United States |
| Arm Dynamics | Portland | Oregon | 97223 | United States |
| Arm Dynamics | Philadelphia | Pennsylvania | 19146 | United States |
| Arm Dynamics | Houston | Texas | 77004 | United States |
| Arm Dynamics | Irving | Texas | 75062 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Disability of the Arm, Shoulder and Hand (DASH) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: no prosthesis (pre-fitting) |
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| Primary | EuroQol-5 Dimension (EQ-5D-5L) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: no prosthesis (pre-fitting) |
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| Primary | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: with prosthesis, immediately post-fitting |
|
|
|
| Primary | Disability of the Arm, Shoulder and Hand (DASH) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: with prosthesis, immediately post-fitting |
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| Primary | EuroQol-5 Dimension (EQ-5D-5L) | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0: with prosthesis, immediately post-fitting |
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| Primary | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 30: with prosthesis, 30 days post-fitting |
|
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| Primary | Disability of the Arm, Shoulder and Hand (DASH) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 30: with prosthesis, 30 days post-fitting |
|
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|
| Primary | EuroQol-5 Dimension (EQ-5D-5L) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 30: with prosthesis, 30 days post-fitting |
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| Primary | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 60: with prosthesis, 60 days post-fitting |
|
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| Primary | Disability of the Arm, Shoulder and Hand (DASH) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 60: with prosthesis, 60 days post-fitting |
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| Primary | EuroQol-5 Dimension (EQ-5D-5L) | 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. | Posted | Mean | Standard Deviation | score on a scale | ~Day 60: with prosthesis, 60 days post-fitting |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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