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Background: A treatment algorithm and screening examination have been developed to guide patient management and prospectively determine potential for highly active individuals to succeed with nonoperative care after anterior cruciate ligament rupture.
Objective: To prospectively characterize and classify the entire population of highly active individuals over a 10-year period and provide final outcomes for individuals who elected nonoperative care.
Methods: Inclusion criteria included presentation within 7 months of the index injury and an International Knee Documentation Committee level I or II activity level before injury. Concomitant injury, unresolved impairments, and a screening examination were used as criteria to guide management and classify individuals as noncopers (poor potential) or potential copers (good potential) for nonoperative care.
Results: A total of 832 highly active patients with subacute anterior cruciate ligament tears were seen over the 10-year period; 315 had concomitant injuries, 87 had unresolved impairments, and 85 did not participate in the classification algorithm. The remaining 345 patients (216 men, 129 women) participated in the screening examination a mean of 6 weeks after the index injury. There were 199 subjects classified as noncopers and 146 as potential copers. Sixty-three of 88 potential copers successfully returned to preinjury activities without surgery, with 25 of these patients not undergoing anterior cruciate ligament reconstruction at the time of follow-up.
Conclusion: The classification algorithm is an effective tool for prospectively identifying individuals early after anterior cruciate ligament injury who want to pursue nonoperative care or must delay surgical intervention and have good potential to do so.
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Dec |
Artificial Pancreas - FDA Provides Options For Designs And StudiesCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
A draft guidance to help artificial pancreas researchers and makers as they create and submit their devices for FDA approval has been issued by the Agency. Artificial pancreases are currently being designed and created for the treatment of diabetes type 1…
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14
Oct |
FDA Panel Conflict Of Interest Restrictions Too Stringent Say SenatorsCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
New measures introduced in 2007 to restrict medical devices experts with potential conflicts of interest from advising the US Food and Drug Administration are too stringent, say Senators who are proposing new legislation to relax regulations that they say are getting in the way of bringing innovative products to market…
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1
Aug |
FDA Should Invest In Developing A New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance ProcessCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine…
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29
Jul |
After 35 Years, Groups Ask FDA To Revaluate Approval SystemCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
The U.S. Food and Drug Administration (FDA) needs to make some changes according to The U.S. Institute of Medicine (IOM) after 35 years of the same, and a report will be released this week that hopes to change the way medical devices are regulated by the agency…
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Jul |
Sapien Heart Valve That Avoids Open Heart Surgery Impresses FDA Reviewers But Safety Concerns RemainCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
Edwards Lifesciences’ new Sapien transcatheter heart valve, an experimental device designed to be inserted through an artery without the need for open heart surgery, appears to have impressed US federal health reviewers, who said in documents released on Monday that the valve “demonstrated superiority” in trials…
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Jun |
Enox Biopharma, Inc. Will Be Granted A Patent For The Delivery Of Therapeutic Agents From Within Medical DevicesCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
Enox Biopharma, Inc., a leader in the development of innovative solutions for infections associated with medical devices, announced that it has received notification from the European Patent Office that its patent application entitled “Device and Method for Administering Therapeutic Agents” has been approved and a patent will be granted. Enox acquired this patent from its Swedish Inventors, Dr…
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Mar |
Non-Invasive Brain Tumor Blaster Gets FDA Panel SupportCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
A new non-invasive device that uses alternating electrical fields to blast brain tumors and kill cancer cells before they can multiply has received the backing of a US Food and Drug Administration (FDA) panel, although two panel members abstained from voting because of concerns that while trials showed the device was safe, it did not appear to be effective…
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4
Aug |
FDA Issues Assessments Of The 510(k) Program And Use Of Science In Decision-MakingCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices - foster device innovation, create a more predictable regulatory environment, and enhance device safety…
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Jun |
Five Genetic Test Makers Told To Get FDA Approval Before Selling Products To The PublicCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
Five makers of genetic tests have been told by the US FDA (Food and Drug Administration) that they have to obtain federal approval before selling and/or marketing their genetic tests to the general public…
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Jan |
Tanning Beds: FDA To Debate Tougher Cancer WarningCategory: Regulatory Affairs / Drug Approvals | Leave a Comment |
Advisors to the US Food and Drug Administration are planning hold a public debate in the spring to discuss the pros and cons of stricter regulations on the use of tanning beds, including stronger warnings on cancer risks and reclassifying them…