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Slow enrollment
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The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.
The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.
This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control femoral neck fracture system | Other | This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONQUEST FN Femoral Neck Fracture System | Device | Fracture fixation device consisting of a single plate and three screws |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation Rate at One Year Post-operation | Reoperation for any reason from time of implantation to one-year post operation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intraoperative Complications | Documentation of any complications related to the implantation of the device | 7 days |
| Classification of Quality of Fracture Reduction | Appropriate reduction was defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. Fractures were then classified as:
If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karlie Morgan | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Trauma Institute Navicent Health Medical Center | Macon | Georgia | 31201 | United States | ||
| Wake Forest School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Femoral Neck Fracture System | This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Femoral Neck Fracture System | This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Reoperation Rate at One Year Post-operation | Reoperation for any reason from time of implantation to one-year post operation | When study was terminated, only 3 participants completed their one year follow up visit. | Posted | Count of Participants | Participants | 1 year |
|
|
Adverse events were collected from the time of surgery through the 1 year follow-up
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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 | Control Femoral Neck Fracture System | This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Screw fracture (Posterior, Proximal), Screw back out (Anterior, Proximal) | Product Issues | Non-systematic Assessment | Device related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Closed head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Not device related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karlie Morgan | Smith+Nephew, Inc. | +1.512.496.7507 | Karlie.Morgan@smith-nephew.com |
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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 | Nov 30, 2018 | Feb 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Operative, 6 weeks, 3 months, 6 months, and 1 year |
| Visual Analogue Scale (VAS) for Pain | The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen. The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip. | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year |
| Quality of Life - EQ-5D-5L | The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels:
The respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state. | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year |
| Timed Up and Go (TUG) | The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor. | 6 Weeks, 3 Months, 6 Months, and 1 year |
| Active Straight Leg Raise (ASLR) Assessment: Evaluation Score | The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do). | 6 Weeks, 3 Months, 6 Months, and 1 year |
| Number of Participants With Construct Failure | Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies. | 6 months post-operative |
| Length of Hospital Stay | Time spent in hospital measured by the number of days | During hospitalization |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| John Peter Smith Hospital | Fort Worth | Texas | 76104 | United States |
| UT Health Science Center San Antonio | San Antonio | Texas | 78829 | United States |
| Sponsor terminated study |
|
| Death |
|
| Sponsor decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-injury Ambulatory Status | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Intraoperative Complications | Documentation of any complications related to the implantation of the device | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Classification of Quality of Fracture Reduction | Appropriate reduction was defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. Fractures were then classified as:
If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views. | Number of Participants Analyzed indicates the data available for each given time frame as specified. | Posted | Count of Participants | Participants | Operative, 6 weeks, 3 months, 6 months, and 1 year |
|
|
|
| Secondary | Visual Analogue Scale (VAS) for Pain | The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen. The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip. | Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year |
|
|
|
| Secondary | Quality of Life - EQ-5D-5L | The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels:
The respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state. | Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year |
|
|
|
| Secondary | Timed Up and Go (TUG) | The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor. | Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated. | Posted | Mean | Standard Deviation | seconds | 6 Weeks, 3 Months, 6 Months, and 1 year |
|
|
|
| Secondary | Active Straight Leg Raise (ASLR) Assessment: Evaluation Score | The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do). | Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated. | Posted | Count of Participants | Participants | 6 Weeks, 3 Months, 6 Months, and 1 year |
|
|
|
| Secondary | Number of Participants With Construct Failure | Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies. | Number Analyzed indicates available participant data for the time frame specified. | Posted | Count of Participants | Participants | 6 months post-operative |
|
|
|
| Secondary | Length of Hospital Stay | Time spent in hospital measured by the number of days | Posted | Mean | Standard Deviation | days | During hospitalization |
|
|
|
| 1 |
| 15 |
| 5 |
| 15 |
| 3 |
| 15 |
|
| End stage Parkinson's Disease | Nervous system disorders | Non-systematic Assessment | Not device related |
|
| St. Elevation Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | Not device related |
|
| Foot infection | Infections and infestations | Non-systematic Assessment | Not device related |
|
| Non union | Product Issues | Non-systematic Assessment | Device related |
|
|
| Ground level fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Not device related |
|
| Redness to right foot | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Not device related |
|
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| D007869 |
| Leg Injuries |
| Grade III |
|
| 6 weeks |
|
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| 3 months |
|
|
| 6 months |
|
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| 1 year |
|
|
|
| 3 Months |
|
|
| 6 Months |
|
|
| 1 Year |
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|
|
| 3 Months |
|
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| 6 Months |
|
|
| 1 Year |
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|
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| 6 Months |
|
|
| 1 Year |
|
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| 2- Somewhat able to do |
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| 3- Fairly difficult |
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| 4- Very difficult |
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| 5- Not able to do |
|
| 3 Months |
|
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| 6 Months |
|
|
| 1 Year |
|
|