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Business decision to remove product from portfolio.
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The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Primary Endpoint:
• Revision rate due to device related complication(s) or non-union of the femur.
Secondary Endpoints:
• Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THP Hip Fracture Plating System | Other | THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THP Hip Fracture Plating System with telescoping lag screws | Device | The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Revision | Revision rate due to device related complication(s) or non-union of the femur. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Radiographic Fracture Healing of the Femur (RUSH) | Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Boylan, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| University of Michigan |
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| ID | Title | Description |
|---|---|---|
| FG000 | THP Hip Fracture Plating System | THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2018 |
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| 6 weeks |
| Average FIX-IT Score (Clinical Fracture Healing of the Femur) | The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points. | 6 weeks |
| Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur) | The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). | 6 weeks |
| Average VAS Pain Score | VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) | 6 weeks |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | THP Hip Fracture Plating System | THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With a Revision | Revision rate due to device related complication(s) or non-union of the femur. | At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants With Radiographic Fracture Healing of the Femur (RUSH) | Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing). | At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Average FIX-IT Score (Clinical Fracture Healing of the Femur) | The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points. | At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| Secondary | Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur) | The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). | At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| Secondary | Average VAS Pain Score | VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) | At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. Only (1) subject was enrolled in this study and they completed their 1-6 week follow-up visit, thus adverse event data only exists through the 1-6 week follow-up visit.
ISO definition is not materially different from clinicaltrials.gov definitions.
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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 | THP Hip Fracture Plating System | THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. | 0 | 1 | 1 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Boylan, Clinical Affairs Manager | Zimmer Biomet | 574-371-9784 | ryan.boylan@zimmerbiomet.com |
| Mar 7, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D025981 | Hip Injuries |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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