Carbo-fix lateral femur plate and standard intramedullary nail-plate constructs have been shown to have lower non-union rates. With decreased non-union rates, re-operation rates will decrease, leading to improved patient outcomes and clinical care. This study will randomize patients to one of the two groups. Then investigators will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in union rates. All procedures are currently standard of care and no procedures are research only.  Detailed Description  Distal femur fractures are quite common, accounting for 3-6% of all femur fractures. In young adults, high energy trauma is most likely the cause, whereas in the elderly population, a low energy trauma due to osteoporosis is likely. Mortality for elderly patients with distal femur fractures is <20% at 1 year and approximately 50% at 5 years. Standard of care treatment for distal femur fractures is open reduction and internal fixation with locking plates, condylar screws, blade plates, or intramedullary nails, depending on the fracture characteristics. Non-union is a known complication of distal femur fixation; recent studies have shown non-union rates up to 33% with lateral locking plating. Patient factors and fracture patterns contribute significantly to the observed success of distal femur fixation operations.  A combined nail-plate fixation has increased in use in recent years, aiming to improve stability and allow early weightbearing. The nail-plate combination significantly increases the chances of the union and is generally used in non-union cases. Its use has flourished and is now an option for primary repair of distal femur fractures. Garala et al compared outcomes among fixation with a single lateral plate and a combined nail-plate construct and found 11 non-unions within the single lateral plate group compared to none in the nail-plate construct.  Metal plates and nails are commonly used for fixation. Carbon fiber, an emerging modality in orthopaedic surgery, has unique physical, chemical, and biological characteristics. It has a high strength to weight ratio and greater tensile strength compared to metallic materials, 7.5 times that of aluminum and 4 times that of steel. A retrospective study using carbon fiber lateral plates in supracondylar periprosthetic femur fractures in elderly patients reported all fractures resulting in union. When compared to titanium, carbon fiber had increased strength, stiffness, and lower wear resistance, as well as an elastic modulus half of bone. The Carbo-fix nails made of CF-PEEK have an advantage relative to metallic nails, although features are similar. These nails offer advantages related to imaging, as they are radiolucent on fluoroscopy and normal radiograph and decrease artifact on CT and MRI.  The purpose of this randomized clinical trial is to decrease non-union rates is distal femur fracture fixation. Carbo-fix lateral femur plate and standard intramedullary nail-plate constructs have been shown to have lower non-union rates. With decreased non-union rates, re-operation rates will decrease, leading to improved patient outcomes and clinical care. This study will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in union rates. All procedures are currently standard of care and no procedures are research only.  Lateral plates and intramedullary nails are used as standard of care for distal femur fractures. Metal plates and nails are typically used, but the Carbofix carbon fiber version of the lateral locking plate can be used as standard of care as well. Non-union rates in the metal lateral locking plates are 20-33%, whereas the carbon fiber plates have a 3-9% non-union rate. The nail-plate combination has a 1-3% non-union rate. Using the Carbofix carbon fiber lateral plates and the standard nail-plate combination can reduce non-union rates in patients and provide better outcomes.  The investigators will be investigating the Carbofix carbon fiber lateral locking plate in this study due to its low non-union rate. This plate is used for distal femur fracture fixation and is FDA approved. Subjects will be randomized to receive the Carbofix carbon fiber lateral locking plate or the typical metal lateral plate and nail combination.  The University of Missouri typically uses the standard metal lateral locking plate and intramedullary nail to treat distal femur fractures. Both are FDA approved.  Study candidates will be screened and identified at morning trauma conference and on the trauma surgery schedule at the University of Missouri Hospital and at Missouri Orthopaedic Institute. A member of the research team will interview the patient in their room while they are at the University of Missouri Hospital/Missouri Orthopaedic Institute. The study, protocol, and consent will be explained to the patient. The patient is encouraged to ask questions and demonstrate understanding of the study. After this, the investigators will obtain informed consent per the IRB protocol. Each candidate will receive a copy of the consent to review with family. Members of the clinic team and research team will collect patient information, previous surgery history, and demographics, including age, sex, BMI, smoking status, and other co-morbidities. This will be collected from the electronic medical chart as well as the patient interview.  The investigators anticipate enrolling 50 patients in the carbon fiber lateral plate cohort and 50 patients in the standard lateral plate plus nail combination cohort over a 2-year enrollment period.  Eligible candidates will be enrolled into the study prior to surgery. Patients will be asked if pregnant. Once informed consent is obtained, the research team will randomize the participant to the carbon fiber lateral plate only or the standard plate-nail combination, both standard of care procedures. A sealed envelope with plate only or plate and nail combination will be opened by a member of the research team. The surgeon will be made aware of which construct will be used prior to surgery. The surgeon will discuss the treatment arm and explain risks to the patient.  Surgical information will be recorded, including length of surgery (in minutes), blood loss, complications during surgery, and any antibiotics used during surgery. Pain medication used following surgery, length of stay, and changes in discharge will also be recorded.  Patients will follow up at standard of care visits - 2 weeks, 6 weeks, 3 months, 6 months, 1 year. At each visit, patients will answer PROs and receive x-rays as per standard of care. Radiographs will be assessed for union; once union is achieved, time to union will be recorded. Pain and pain medication use will be recorded at each subsequent visit. PROs include VAS pain score, PROMIS physical function, and PROMIS pain interference will be recorded as well.  There is minimal risk with breach of confidential medical information. Efforts will be made to avoid the breach of confidentiality. Records are given a study identification number that will be free of subject's name and identifiers. Identification numbers connected with subjects' names will be kept in a secure location and otherwise will be archived in a secure storage facility or destroyed.  Anticipated benefits include possible reduction in non-union rates, which could lead to better patient outcomes and improved treatment in orthopaedic surgery.  Subject safety will be ensured through standard of care procedures and monitoring by clinical and surgical staff.  Official Title  Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures  Conditions  Distal Femur Fracture  Distal Femur Fracture  Distal Femur Fracture  Distal Femur Fracture  Intervention / Treatment  Device Carbo-fix Lateral Plate Device  Device Standard Plate-Nail Construct  Other Study ID Numbers  Study Start Estimated  Primary Completion Estimated  Study Completion Estimated  Enrollment Estimated  Study Type  Interventional  Phase  Not Applicable  Resource links provided by the National Library of Medicine  FDA Drug and Device Resources  (https://clinicaltrials.gov/fda-links)  Contacts and Locations  This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.  To learn more, please see the Contacts and Locations section in How to Read a Study Record (https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations)  Study Contact  Name: Vicki L Jones, MEd  Phone Number:  Email: jonesvicki@health.missouri.edu  Study Contact Backup  Name: Nash Kolb  Phone Number:  Email: kolbn@health.missouri.edu  This study has 1 location  United States  Missouri Locations  Columbia, Missouri, United States, 65201  University of Missouri-Columbia  Contact  Vicki L Jones, MEd  jonesvicki@health.missouri.edu  Principal Investigator  Kyle M Schweser, MD  Click to view interactive map  Participation Criteria  Researchers look for people who fit a certain description, called eligibility criteria . Some examples of these criteria are a person's general health condition or prior treatments.  For general information about clinical research, read Learn About Studies (https://clinicaltrials.gov/study-basics/learn-about-studies)  Eligibility Criteria  Description  Inclusion Criteria:  Adult patients, 18 years or older, with a distal femur fracture requiring surgery  Adult patients able to understand and sign the consent and answer PROs  Exclusion Criteria:  Age under 18 years  Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)  Unable to give consent  Prisoner  Mentally disabled  Ages Eligible for Study  18 Years and older  Adult Older Adult  Sexes Eligible for Study  All  Accepts Healthy Volunteers  No  Study Plan  This section provides details of the study plan, including how the study is designed and what the study is measuring.  Expand all Collapse all  How is the study designed?  Design Details  Primary Purpose  Treatment  Allocation  Randomized  Interventional Model  Parallel Assignment  Masking  None (Open Label)  Arms and Interventions  Participant Group/Arm  Intervention/Treatment  Participant Group/Arm  Active Comparator  Carbo-fix Lateral Plate Device  Intervention/Treatment  Device Carbo-fix Lateral Plate Device  Participants that are randomized to this group will have their distal femur fracture repaired with the Carbofix carbon fiber lateral locking plate  Participant Group/Arm  Active Comparator  Standard Plate-Nail Construct  Intervention/Treatment  Device Standard Plate-Nail Construct  Participants who randomize to this group will have their distal femur fracture repaired with the standard lateral plate and intramedullary nail construct.  What is the study measuring?  Primary Outcome Measures  Outcome Measure  Measure Description  Time Frame  The total number of participants that have non-union of their distal femur fractures when utilizing a carbon fiber lateral plate only or a standard nail/plate combination as assessed by standard of care radiographs.  1 year  Secondary Outcome Measures  Outcome Measure  Measure Description  Time Frame  The average scores of the patient reported outcomes for pain scores in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care with VAS Pain scores.  Visual Analogue Scale (VAS) pain scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.  1 year  The average scores of the patient reported outcomes for the PROMIS PF in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.  Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.  1 year  The average scores of the patient reported outcomes for the PROMIS PI in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.  Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.  1 year  The total number of patients with infection in the lateral plate versus the nail plate combination cohorts as assessed by standard of care wound check at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.  1 year  The average time to union (weeks) for the Carbo-fix lateral plate versus nail plate combination as assessed by standard of care radiographs  1 year  The average time to return to activity (weeks) after the Carbo-fix lateral plate versus the nail plate combination as assessed by standard of care follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.  1 year  The total number of patients undergoing reoperation with the Carbo-fix lateral plate versus the nail plate combination as assessed by standard of care follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.  1 year  The total number of patients with malalignment of the femur with the Carbo-fix lateral plate versus the nail/plate combination as assessed by standard of care radiographs.  1 year  The average surgical time (minutes) for patients in both treatment groups, as assessed by standard of care documentation.  1 year  The average amount of blood loss (mL) for patients during surgical fixation for both treatment groups, as assessed by standard of care documentation.  1 year  The average length of stay (days) for admission for surgical fixation for patients in each treatment group, as assessed by standard of care documentation.  1 year  The total number of patients in each discharge disposition category (home, skilled nursing facility, or inpatient rehab) upon discharge after surgical fixation for each treatment group as assessed by standard of care documentation.  1 year  Collaborators and Investigators  This is where you will find people and organizations involved with this study.  Sponsor  University of Missouri-Columbia  Collaborators  CarboFix Orthopedics Ltd.  Investigators  Principal Investigator  Kyle M Schweser, MD  University of Missouri-Columbia  Publications  General  These publications are provided voluntarily by the person who enters information about the study and may be about anything related to the study.  Utility of Carbon Fiber Implants in Orthopedic Surgery: Literature Review Ronald Hillock, MD, Shain Howard, BS Reconstructive Review v. 4, n. 1 (31 March 2014): 55-55  Garala K, Ramoutar D, Li J, Syed F, Arastu M, Ward J, Patil S. Distal femoral fractures: A comparison between single lateral plate fixation and a combined femoral nail and plate fixation. Injury. 2022 Feb;53(2):634-639. doi: 10.1016/j.injury.2021.11.011. Epub 2021 Nov 10.  (https://pubmed.ncbi.nlm.nih.gov/34836629)  Rodriguez EK, Boulton C, Weaver MJ, Herder LM, Morgan JH, Chacko AT, Appleton PT, Zurakowski D, Vrahas MS. Predictive factors of distal femoral fracture nonunion after lateral locked plating: a retrospective multicenter case-control study of 283 fractures. Injury. 2014 Mar;45(3):554-9. doi: 10.1016/j.injury.2013.10.042. Epub 2013 Nov 4.  (https://pubmed.ncbi.nlm.nih.gov/24275357)  Ebraheim NA, Martin A, Sochacki KR, Liu J. Nonunion of distal femoral fractures: a systematic review. Orthop Surg. 2013 Feb;5(1):46-50. doi: 10.1111/os.12017.  (https://pubmed.ncbi.nlm.nih.gov/23420747)  Khan AM, Tang QO, Spicer D. The Epidemiology of Adult Distal Femoral Shaft Fractures in a Central London Major Trauma Centre Over Five Years. Open Orthop J. 2017 Nov 13;11:1277-1291. doi: 10.2174/1874325001711011277. eCollection 2017.  (https://pubmed.ncbi.nlm.nih.gov/29290866)  Study Record Dates  These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.  Study Registration Dates  First Submitted  First Submitted that Met QC Criteria  First Posted  Study Record Updates  Last Update Submitted that met QC Criteria  Last Update Posted  Last Verified  More Information

Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

• Rest of World (ROW)
This study identifies the advancement in surgery procedure as one of the prime reasons driving the orthopedic pedicle screws market growth during the next few years. Also, growing focus on development of bioengineered orthopedic pedicle screws and new technologies related to orthopedic pedicle screws will lead to sizable demand in the market. The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters. Our report on orthopedic pedicle screws market covers the following areas:
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This robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading orthopedic pedicle screws market vendors that include Alphatec Holdings Inc., B. Braun SE, Captiva Spine Inc., CarboFix Orthopedics Ltd., Dieter Marquardt Medizintechnik GmbH, Genesys Orthopedic Systems LLC, Globus Medical Inc., HPI Implants, Johnson and Johnson, Medacta Group SA, Medtronic Plc, Mirus LLC, Nuvasive Inc., Orthofix Medical Inc., OrthoPediatrics Corp., Safe Orthopaedics, Spinal Elements Inc., Spineart SA, SpineCraft LLC, SpineGuard SA, Stryker Corp., and Zimmer Biomet Holdings Inc. Also, the orthopedic pedicle screws market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities. The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors. The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive research - both primary and secondary. Technavio’s market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast the accurate market growth.

The Global Orthopedic Pedicle Screws Market is expected to grow by $ 299.97 mn during 2022-2026, accelerating at a CAGR of 7.73% during the forecast period

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NEW YORK, Dec. 20, 2021 /PRNewswire/ -- Technavio's latest research report on the Pedicle Screw System Market offers a comprehensive analysis of new product launches, the latest trends, drivers, and challenges  The pedicle screw system market share growth by the monoaxial and polyaxial orthopedic pedicle screws segment will be significant for revenue generation. The presence of companies that offer biocompatible orthopedic pedicle screws with better stability will boost the adoption of monoaxial and polyaxial orthopedic pedicle screws. Also, the adoption of orthopedic surgical navigation products in MI spine surgeries will help boost the adoption of MI spine surgeries, which, in turn, will fuel the growth of the monoaxial and polyaxial orthopedic pedicle screws segment. Vendors are focusing on developing monoaxial and polyaxial orthopedic pedicle screws that can be used for various spine surgical procedures. Attractive Opportunities in Pedicle Screw System Market by Product and Geography - Forecast and Analysis 2021-2025
The pedicle screw system market size is expected to increase by USD 212.03 million, at a CAGR of 6.60% from 2020 to 2025 as per the latest market report by Technavio. Market Dynamics
The market is driven by factors such as the increasing number of spine surgeries, growing number of product launches, and strategic business partnerships. However, the high costs associated with spine surgery is hindering market growth. The holistic analysis of the drivers & challenges will help in deducing end goals and refining marketing strategies to gain a competitive edge. The pedicle screw system market analysis report also provides detailed information on other upcoming trends and challenges that will have a far-reaching effect on the market growth
Company Profiles
The pedicle screw system market is fragmented and the vendors are deploying growth strategies such as developing new products with advanced technologies to compete in the market. The pedicle screw system market report provides complete insights on key vendors including Alphatec Holdings Inc., B. Braun Melsungen AG, Captiva Spine Inc., CarboFix Orthopedics Ltd., Genesys Orthopedic Systems LLC, Globus Medical Inc., HPI Implants, Johnson and Johnson Inc., Stryker Corp., and Zimmer Biomet Holdings Inc.
Few companies with key offerings
Alphatec Holdings Inc. - The company offers pedicle screw system products under the brand name of SingleStep. B. Braun Melsungen AG - The company offers pedicle screw system products under the brand name Ennovate. Captiva Spine Inc. -  The company offers pedicle screw system products under the brand name TowerLOX-EXT. CarboFix Orthopedics Ltd. -  The company offers pedicle screw system products under the brand name of CarboClear. Genesys Orthopedic Systems LLC - The company offers pedicle screw system products under the brand name Thoracolumbar. Competitive Analysis
The report includes the competitive analysis, a proprietary tool to analyze and evaluate the position of companies based on their industry position score and market performance score. The tool uses various factors for categorizing the players into four categories. Some of these factors considered for analysis are financial performance over the last 3 years, growth strategies, innovation score, new product launches, investments, growth in market share, etc. Market Segmentation
By Product, the market is classified into monoaxial & polyaxial orthopedic pedicle screws and cannulated orthopedic pedicle screws. By Geography, the market is classified as North America, Europe, Asia, and ROW. North America will have the largest share of the market. Related Reports-
Digital Diabetes Management Market -The digital diabetes management market share is expected to increase by USD 12.45 billion from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 21.15%. Download a free sample now! Sternal Closure Systems Market -The sternal closure systems market share is expected to increase by USD 659.76 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 5.69%. Download a free sample now! Pedicle Screw System Market Scope
Report Coverage
Companies profiled
Alphatec Holdings Inc., B. Braun Melsungen AG, Captiva Spine Inc., CarboFix Orthopedics Ltd., Genesys Orthopedic Systems LLC, Globus Medical Inc., HPI Implants, Johnson and Johnson Inc., Stryker Corp., and Zimmer Biomet Holdings Inc.
Market Dynamics
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and future consumer dynamics, market condition analysis for the forecast period,
Customization purview
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. About Us
Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact

Pedicle Screw System Market to Increase by USD 212.03 mn from 2020 to 2025|  |Monoaxial &amp; Polyaxial Orthopedic Pedicle Screws Segment to be significant for Revenue Generation |17000+ Technavio Reports

Dec 20, 2021, 23:00 ET
Pedicle Screw System Market to Increase by USD 212.03 mn from 2020 to 2025| |Monoaxial & Polyaxial Orthop...

Written by Eric Oliver | October 25, 2019 | Print  | Email
Thirteen orthopedic and spine device companies that recently launched or released devices:
Alphatec recently launched its porous titanium line of IdentiTi implants for lateral interbody fusion procedures. CarboFix launched CarboClear, its new carbon fiber vertebral body replacement system. Xtant Medical launched two cervical interbody spacers and one PEEK implant last month. German orthobiologics company curasan AG launched Spinevisc, a biomimetic hyaluronic acid product to treat spinal facet joint arthrosis. Brainlab launched Loop-X, a mobile intraoperative imaging robot. OrthoMed recently launched its reusable nitinol trial rod for lumbar fixation. Kuros Biosciences unveiled its new bone graft, MagnetOs. RTI Surgical added to its Established Therapies spine portfolio with the launch of CervAlign, an anterior cervical plate system. Medtronic unveiled four new additions to its Surgical Synergy platform. More articles on devices:

Medtronic, Alphatec & more: 13 device company launches, releases

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CarboFix Orthopedics focuses on the development, manufacturing, and marketing of orthopedic implants in the spine and trauma sectors. The company offers a range of products including plates and nails designed to support surgery procedures, utilizing carbon fiber reinforced polymer. These products are primarily sold to healthcare providers specializing in care. It was founded in 2009 and is based in Herzliya, Israel.

Date
Round	Other Investors
Amount
Investors	Pitango
Valuation	$XXM
Revenue	0 FY undefined
Sources

First funding
Last Funding
Investor	Pitango
Rounds	1 Other Investors
Board Seats
Type	Venture Capital
Location	Israel

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