The Mobi-C Cervical Disc is one of the most widely used cervical discs in the world. First implanted in France in November 2004, Mobi-C has now been implanted in more than 75,000 spinal levels in 25 countries. Mobi-C is intended for adult patients (skeletally mature) with arm pain and/or neurological symptoms (such as weakness or numbness) with ...An infection at the surgery site, such as a skin rash or infected cut. A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy. Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels.Nov 28, 2017 · One limitation of this study was the specific inclusion and exclusion criteria for entry into the study. At the time of conception, the intention of the Mobi-C study was to enroll patients without significant conditions that could confound the outcome of an artificial disc. Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental kyphosis at the level of the implant. All implants were locked in the flexion position, and all patients required reoperation. This is the first reported case series of ...Zimmer Biomet Spine has announced that more than 150,000 Mobi-C Cervical Discs have been implanted worldwide. Zimmer Biomet holds a commanding position in the $200 million global cervical disc market, according to the company. The Mobi-C device represents an optimal solution with statistical superiority to two-level fusion at seven years.Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement.Mobi-C’s foundation is the patented mobile core, which offers controlled mobility and encourages height restoration. The components of Mobi-C include superior and inferior Cobalt Chromium alloy endplates coated with plasma sprayed Titanium and hydroxyapatite coating, and a polyethylene mobile bearing insert.May 01, 2019. SAN DIEGO — Improvements were sustained at 10 years for patients treated with the Mobi-C cervical disc in the trial that led to its approval by the US Food and Drug Administration ...The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine. Methods: This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 ... Results: There was no statistical significance in the difference of overall flexion range between M6-C and Mobi-C prostheses. However, overall range of extension of Mobi-C was greater compared to M6-C (P = 0.028). At C 5-6, the range of flexion for both implants were similar but lesser compared to asymptomatic patients (P < 0.001). Range of ... The average return to work time was 20.9 days shorter for Mobi-C compared to ACDF. The patients in this study will continue to be followed for 7 years after surgery. The clinical benefit beyond five years has not been measured. To find a trained Mobi-C surgeon, please visit the surgeon locator. Potential adverse effects from surgery with the Mobi-CMar 23, 2016 · The Mobi-C cervical disc is one of the most widely used cervical discs in the world. Mobi-C contains patented Mobile Core Technology™ that allows the polyeth... Seven patients (3%) treated with Mobi-C and twelve patients (11%) treated with ACDF, had surgery at an adjacent level within 5 years after surgery. No mechanical failures of the Mobi-C device were observed in any study patients. A comprehensive list of risks is provided in the package insert for the device, which your doctor has received. J Neurosurg Spine. 2014;21(4):516-28., 3 Hisey MS, Zigler JE, Jackson R, et al. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016;10:10. LDR Spine –Mobi-C® P110009 Page 3 of 82 The Mobi-C® endplates are available in seven footprint sizes to address individual patient anatomy and maximize endplate coverage. These sizes are illustrated in the table below. Table 1. Mobi-C® Device Configurations Depth x Width (mm) Inferior/Superior Plate & Mobile Insert Sizes Combinations ...In a surgery with the Mobi-C Cervical Disc, the unhealthy disc is removed, but instead of a bone spacer or plastic implant along with a plate and screws, a Mobi-C is implanted into the disc space. Where a fusion procedure is intended to eliminate motion at the surgery levels, the goal of a surgery with Mobi-C is to allow motion at those levels. The Mobi-C is composed of three parts—two metal plates that sandwich a plastic insert. While other artificial discs require neurosurgeons to chisel bone and drill screws to hold the device in place, the Mobi-C has teeth on the top and bottom to secure the plates to the vertebrae on either side.Jul 31, 2020 · Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental kyphosis at the level of the implant. All implants were locked in the flexion position, and all patients required reoperation. This is the first reported case series of ... Dec 8, 2017 · The Mobi-C cervical artificial disc (LDR Medical; Troyes, France) is a semiconstrained, mobile bearing, bone-sparing TDR consisting of 2 cobalt–chromium–molybdenum alloy endplates and an ultra-high-molecular-weight polyethylene mobile insert facilitating 5 independent degrees of freedom. Ethical standards: The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. Level of evidence: 1.Dr. Louis Radden is offering an alternative to neck fusion surgery, and is one of a few surgeons in Michigan to perform this breakthrough procedure. Mobi-C Cervical Disc was FDA approved for use in the United States in 2013 and to date has been used worldwide in over 40,000 procedures with superb results. It is also the first cervical disc ...What is Mobi-C. Mobi-C is the first cervical disc in the U.S. approved to treat more than one level of the cervical spine. It received FDA approval for one and two-level indications in August 2013. Mobi-C demonstrated statistical superiority compared to cervical spine fusion in overall study success when used in two-level patients at 5 years. The Mobi-C cervical artificial disc (LDR Medical; Troyes, France) is a semiconstrained, mobile bearing, bone-sparing TDR consisting of 2 cobalt–chromium–molybdenum alloy endplates and an ultra-high-molecular-weight polyethylene mobile insert facilitating 5 independent degrees of freedom.The Mobi-C Cervical Disc (Zimmer Biomet, Warsaw, IN—formerly LDR Spine, Austin, TX) is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is indicated for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy in patients ages 21 to 67 years.²Zip. Institution. Map. Details. Email These Surgeons to Me. Zimmer Biomet is pleased to provide the Surgeon Locator to allow you to find surgeons who have been trained on Mobi-C. This locator may not be a complete list of trained surgeons in your area, and Zimmer Biomet does not make any recommendation or referral regarding the proper facility ... An infection at the surgery site, such as a skin rash or infected cut. A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy. Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels. Mobi-C is a great option, arguably the best option in the correct patient. The main benefit of a Mobi-C is that you adjacent levels are less likely to break down and cause issues due to the fact that the natural range of motion is preserved. A disc replacement in the cervical spine is a great option for the correct pathology.Return to Mobi-C Homepage If unsure about the answers to these questions, please consult with your doctor about your condition. This is for educational purposes only and is not meant to replace a conversation with and examination by a qualified physician. Restoring natural motion to the cervical spine. The controlled mobility of the patented mobile core is the foundation of Mobi-C. With vertebrae and neck muscle movement, the Mobi-C implant is free to twist and slide left-to-right, and front-to-back, as well as rotate. 詳細. 移動式インサートの可動性を制御することは、Mobi-C® ディスクプロテーゼの基礎です。. この第 2 世代の人工椎間板は、脊髄関節形成術を専門とする外科医のチームによって設計されました。. Mobi-Cはユニークで信頼性が高く、特許取得済みの移植 ...The average return to work time was 20.9 days shorter for Mobi-C compared to ACDF. The patients in this study will continue to be followed for 7 years after surgery. The clinical benefit beyond five years has not been measured. To find a trained Mobi-C surgeon, please visit the surgeon locator. Potential adverse effects from surgery with the Mobi-C Mobi-C’s foundation is the patented mobile core, which offers controlled mobility and encourages height restoration. The components of Mobi-C include superior and inferior Cobalt Chromium alloy endplates coated with plasma sprayed Titanium and hydroxyapatite coating, and a polyethylene mobile bearing insert.Mobi C Artificial Disc New research studies by the North American Spine Society — the most respected international society of spine surgeons — have shown that when a person has a herniated disc in the neck, and traditional fusion surgery is performed, there is an increased incidence of herniation at an adjacent segment.Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement.Nov 28, 2017 · One limitation of this study was the specific inclusion and exclusion criteria for entry into the study. At the time of conception, the intention of the Mobi-C study was to enroll patients without significant conditions that could confound the outcome of an artificial disc. the mobi-c® cervical disc prosthesis is implanted using an anterior approach. patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the mobic® cervical disc prosthesis. approval order: approval order: summaryApr 28, 2016 · Mobi-C® Cervical Disc is the first and only neck surgery prosthesis approved for reconstruction of the disc(s) from C3-C7 following discectomy at one or two ... Results: There was no statistical significance in the difference of overall flexion range between M6-C and Mobi-C prostheses. However, overall range of extension of Mobi-C was greater compared to M6-C (P = 0.028). At C 5-6, the range of flexion for both implants were similar but lesser compared to asymptomatic patients (P < 0.001). Range of ...However, Mobi-C disc replacement is very different in a number of ways. The purpose of the replacement surgery is obviously to replace the damaged disc and help with neck pain, arm pain, and arm tingling, for instance. However, the device is designed to promote neck movement (including turning left-to-ride, bending side-to-side, and bending ... The Mobi-C ® Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following ... Dec 1, 2022 · Page 1 of 7 Last Updated 01-DECEMBER-2022 . Zimmer Biomet Patent Marking . This information is provided as notice of patented articles pursuant to 35 U.S.C. § 287(a). Only 1 study analyzed outcomes of 1-level versus 2-level Mobi-C CDA, and only 1 study analyzed 2-level Mobi-C CDA versus 2-level ACDF. In comparison with other cervical disc prostheses, the Mobi-C prosthesis is associated with higher rates of heterotopic ossification (HO). Studies with conflicts of interest reported lower rates of HO. The Mobi-C Cervical Disc (Zimmer Biomet, Warsaw, IN—formerly LDR Spine, Austin, TX) is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is indicated for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy in patients ages 21 to 67 years.²Mobi-C’s foundation is the patented mobile core, which offers controlled mobility and encourages height restoration. The components of Mobi-C include superior and inferior Cobalt Chromium alloy endplates coated with plasma sprayed Titanium and hydroxyapatite coating, and a polyethylene mobile bearing insert.Dec 1, 2022 · Page 1 of 7 Last Updated 01-DECEMBER-2022 . Zimmer Biomet Patent Marking . This information is provided as notice of patented articles pursuant to 35 U.S.C. § 287(a). Mobi-C® Cervical Disc. The upper and lower bone-facing endplates of the Mobi-C® Cervical Disc are made of a cobalt chromium molybdenum alloy. The endplates are coated with a fine layer of titanium and hydroxyapatite to promote integration with bone. The replacement Mobi-C device has not failed to date, unlike the first Mobi-C device, which failed 1 week postoperatively in this same patient. This result likely rules out patient factors as the underlying cause of failure and may speak to the increased need to have a very precise surgical technique to prevent anterior slippage of the endplate ...Nov 28, 2017 · Ethical standards: The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. Level of evidence: 1. The changes in clinical and radiological measures were comparable between M6-C and Mobi-C prostheses. Thirty-seven out of 52 spinal segments (71.2%) and 10 out of 16 spinal segments (62.5%) developed HO in M6-C and Mobi-C group respectively. There was no significant difference in the rate of HO between the two groups.An infection at the surgery site, such as a skin rash or infected cut. A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy. Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels. An infection at the surgery site, such as a skin rash or infected cut. A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy. Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels. Zip. Institution. Map. Details. Email These Surgeons to Me. Zimmer Biomet is pleased to provide the Surgeon Locator to allow you to find surgeons who have been trained on Mobi-C. This locator may not be a complete list of trained surgeons in your area, and Zimmer Biomet does not make any recommendation or referral regarding the proper facility ...The Mobi-C® Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain,Mobi-C – How it Works. Mobi-C contains patented mobile bearing technology that allows the polyethylene core to slide and rotate inside the disc for self-adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine.Mobi-C® Cervical Disc. The upper and lower bone-facing endplates of the Mobi-C® Cervical Disc are made of a cobalt chromium molybdenum alloy. The endplates are coated with a fine layer of titanium and hydroxyapatite to promote integration with bone. Nov 17, 2016 · The Mobi-C Cervical Disc (Zimmer Biomet, Warsaw, IN—formerly LDR Spine, Austin, TX) is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is indicated for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy in patients ages 21 to 67 years.² About this app. Mobile trade support system "Mobi-S" is a software package designed to automate the work of sales representatives. Automate order picking, wheel trading and collecting merchandising information. Easy integration with the main configurations of 1C Enterprise 8.2, 8.3 and 7.7. There is everything you need to collect applications ...What is Mobi-C. Mobi-C is the first cervical disc in the U.S. approved to treat more than one level of the cervical spine. It received FDA approval for one and two-level indications in August 2013. Mobi-C demonstrated statistical superiority compared to cervical spine fusion in overall study success when used in two-level patients at 5 years. The Mobi-C Cervical Disc is now available to more than 200 million insured patients with one-level disc disease and more than 150 million patients with two-level disc disease across more than 90 commercial insurance plans. That makes Mobi-C the most widely covered intervertebral disc for cervical disc replacement in the industry.Nov 28, 2017 · One limitation of this study was the specific inclusion and exclusion criteria for entry into the study. At the time of conception, the intention of the Mobi-C study was to enroll patients without significant conditions that could confound the outcome of an artificial disc. Apr 13, 2020 · Zimmer Biomet Spine has announced that over 150,000 Mobi-C Cervical Discs have been implanted worldwide. The implant, a cobalt chromium alloy and polyethylene mobile-bearing prosthesis, was first implanted in France in 2004 and was approved for sale in the U.S. by the FDA in 2013. Noting the bulwark of data on the device, James Cloar, President ... The Mobi-C disc is one of the most common options for replacement cervical discs around the world. The medical device was first used in 2004 and has continued to be used successfully in patients with cervical disc issues (that is, disc issues in the neck). Without a doubt, many people who have undergone a Mobi-C disc procedure have had ... May 1, 2018 · Mobi-C discs from 16 patients and M6-C discs from 56 patients, both MoP implants, were compared in terms of the range of motion by Pham et al. [20]. A range of motion of 14.2 °± 5.1 °for Mobi-C ... Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling or other vertebral anchorage such as screws or keels.The Mobi-C® Cervical Disc Prosthesis (Mobi-C®) is a single use device for cervical intervertebral disc replacement at one level from C3 to C7 in order to maintain/restore segmental motion and disc height. The components of the Mobi-C® include a cobalt, chromium, molybdenumOne limitation of this study was the specific inclusion and exclusion criteria for entry into the study. At the time of conception, the intention of the Mobi-C study was to enroll patients without significant conditions that could confound the outcome of an artificial disc.Restoring natural motion to the cervical spine. The controlled mobility of the patented mobile core is the foundation of Mobi-C. With vertebrae and neck muscle movement, the Mobi-C implant is free to twist and slide left-to-right, and front-to-back, as well as rotate. Mobi-C is non-inferior to ACDF at one level and superior at two levels2 Mobi-C had lower rates of adjacent segment degeneration at 84 months Mobi-C had fewer subsequent surgeries at 84 months One-level deterioration of adjacent segments at 84 months compared to baseline: • 43.8% for Mobi-C compared to 63.0% for ACDF at the inferior level.Dr. Louis Radden is offering an alternative to neck fusion surgery, and is one of a few surgeons in Michigan to perform this breakthrough procedure. Mobi-C Cervical Disc was FDA approved for use in the United States in 2013 and to date has been used worldwide in over 40,000 procedures with superb results. It is also the first cervical disc ...MOBI-C® prosthesis is a device for cervical intervertebral disc replacement (C3/C4, C4/C5, C5/C6, C6/C7) in order to restore segmental motion and disc height. Before any surgical procedure, read carefully the instructions and the surgical technique. Open the catalog to page 1. SURGICAL TECHNIQUE Pre-operative considerations Implant height ... The Mobi-C cervical disc is one of the most widely used cervical discs in the world. Mobi-C contains patented Mobile Core Technology™ that allows the polyeth...However, Mobi-C disc replacement is very different in a number of ways. The purpose of the replacement surgery is obviously to replace the damaged disc and help with neck pain, arm pain, and arm tingling, for instance. However, the device is designed to promote neck movement (including turning left-to-ride, bending side-to-side, and bending ... Dr. Louis Radden is offering an alternative to neck fusion surgery, and is one of a few surgeons in Michigan to perform this breakthrough procedure. Mobi-C Cervical Disc was FDA approved for use in the United States in 2013 and to date has been used worldwide in over 40,000 procedures with superb results. It is also the first cervical disc ... However, Mobi-C disc replacement is very different in a number of ways. The purpose of the replacement surgery is obviously to replace the damaged disc and help with neck pain, arm pain, and arm tingling, for instance. However, the device is designed to promote neck movement (including turning left-to-ride, bending side-to-side, and bending ...Seven patients (3%) treated with Mobi-C and twelve patients (11%) treated with ACDF, had surgery at an adjacent level within 5 years after surgery. No mechanical failures of the Mobi-C device were observed in any study patients. A comprehensive list of risks is provided in the package insert for the device, which your doctor has received. The Mobi-C Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc. Physician CPT® Code CPT Description Insertion 22856Zip. Institution. Map. Details. Email These Surgeons to Me. Zimmer Biomet is pleased to provide the Surgeon Locator to allow you to find surgeons who have been trained on Mobi-C. This locator may not be a complete list of trained surgeons in your area, and Zimmer Biomet does not make any recommendation or referral regarding the proper facility ... An infection at the surgery site, such as a skin rash or infected cut. A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy. Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels.The Mobi-C prosthesis is composed of two endplates made of cobalt, chromium, and 29-molybdenum alloy, with non-constrained polyethylene insert 25. The self-retaining teeth are designed for optimal anchorage and stability 25. Mobi-C mobility is controlled by movement of the superior plate which re-positions the mobile insert on the inferior ...Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.
About Mobi-C. What is the Mobi-C Cervical Disc? How does Mobi-C Compare to Fusion? Who Should Receive a Mobi-C? Complications & Precautions; What are the 10 year clinical results? Insurance Coverage; Real Experiences; Am I a Candidate? Surgeon Locator; Contact; I am a Surgeon. Clinical Results; Surgeon Testimonials; Press Kit; Insurance .... Claymore demon
Mobi-C Cervical Disc is an artificial disc that can replace a worn or degenerative disc. This surgery helps provide both lateral and vertical range of motion along with maintaining neck rotation. This differs from spinal fusion surgery when two of the vertebrae are fused together with hardware, which constricts the neck’s range of motion. Dec 8, 2017 · The Mobi-C cervical artificial disc (LDR Medical; Troyes, France) is a semiconstrained, mobile bearing, bone-sparing TDR consisting of 2 cobalt–chromium–molybdenum alloy endplates and an ultra-high-molecular-weight polyethylene mobile insert facilitating 5 independent degrees of freedom. Mobi C Artificial Disc New research studies by the North American Spine Society — the most respected international society of spine surgeons — have shown that when a person has a herniated disc in the neck, and traditional fusion surgery is performed, there is an increased incidence of herniation at an adjacent segment.Dr. Louis Radden is offering an alternative to neck fusion surgery, and is one of a few surgeons in Michigan to perform this breakthrough procedure. Mobi-C Cervical Disc was FDA approved for use in the United States in 2013 and to date has been used worldwide in over 40,000 procedures with superb results. It is also the first cervical disc ...Mobi-C group composed of 15 subjects, in which 6 were male and 9 were female. There were no statistical differences in demographics and baseline characteristics of subjects between the M6-C and Mobi-C groups, including age, gender, BMI, smoking history, the type of surgery, ROM and FSU height ( Table 7 ).The Mobi-C has three parts: two metal plates and a medical grade polyethylene insert in the middle. The top plate rotates over the domed insert. The insert slides across the bottom plate, left-to-right and front-to-back up to 1mm in any direction. The insert also twists over the bottom plate. The two tabs on the bottom plate provide a safety ...The Mobi-C Cervical Disc was designed to complement the natural anatomy and motion of the cervical spine. With an anatomy-mimicking convex superior endplate and a mobile core intended to move with the spine, Mobi-C allows 5 independent degrees of freedom: 2 translational and 3 rotational (Fig. 1), facilitating both independent and coupled motions similar to the natural motion of the cervical ...Mar 23, 2016 · The Mobi-C cervical disc is one of the most widely used cervical discs in the world. Mobi-C contains patented Mobile Core Technology™ that allows the polyeth... May 01, 2019. SAN DIEGO — Improvements were sustained at 10 years for patients treated with the Mobi-C cervical disc in the trial that led to its approval by the US Food and Drug Administration ...In 2015, FDA approved an update to the Mobi-C labeling to include five year clinical results. Of note, Mobi-C demonstrated superiority at all time points to five years on overall trial success as compared to two-level ACDF. The Mobi-C consists of two cobalt chromium (CoCr) endplates that are plasma sprayed with titanium Nov 28, 2017 · Ethical standards: The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. Level of evidence: 1. .
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