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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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Nov |
Medical Device Market Access & Government Affairs Conference, December 5 -6, 2011, TorontoCategory: Conferences | Leave a Comment |
Q1 Productions announces its upcoming Medical Device Market Access & Government Affairs Conference will be held this winter in Toronto. Presently, as market access structures for medical devices in the Canadian provinces continues to evolve and gain interest and attention throughout the world, device companies face challenges in securing successful funding and reimbursement for their products…
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Nov |
Medical Device Regulatory Clearance & Approval Conference, December 8 - 9, 2011, Baltimore, MDCategory: Conferences | Leave a Comment |
Q1 Productions’ upcoming Medical Device Regulatory Clearance & Approval Conference this winter will be held just as the device industry experiences greater regulatory scrutiny from FDA. Several instances of device failures and high profile recalls have resulted in the Agency looking closer at devices on the market and their approval processes…
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Nov |
Medical Device Regulatory Clearance & Approval Conference, December 8 - 9, 2011, Baltimore, MDCategory: Conferences | Leave a Comment |
Q1 Productions’ upcoming Medical Device Regulatory Clearance & Approval Conference this winter will be held just as the device industry experiences greater regulatory scrutiny from FDA. Several instances of device failures and high profile recalls have resulted in the Agency looking closer at devices on the market and their approval processes…
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Sep |
4th Annual European Medical Device Clinical Research Conference, October 10 - 11, 2011, Frankfurt, GermanyCategory: Conferences | Leave a Comment |
Q1 Productions’ 4th Annual European Medical Device Clinical Research Conference this October will provide presentations to address a wide variety of challenges, providing clarity and direction for organizations that are both in the process of conducting studies, and also considering a clinical study for their product…
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Aug |
Medical Device Investigator Initiated Studies Conference, September 19-20, 2011, ChicagoCategory: Conferences | Leave a Comment |
Maximizing Value from Investigator Initiated Trials in the Medical Device Industry through Overcoming Regulatory and Funding Challenges, Aligning Programs with Company Strategies and Managing Investigator Relationships Around the world, medical device corporations are increasingly being asked for funding and support of investigator initiated research studies…
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Aug |
Pharmaceutical & Medical Device Talent Management Conference, September 19-20, 2011, ChicagoCategory: Conferences | Leave a Comment |
Evaluating Opportunities and Best Practices Surrounding the Recruitment and Retention of Top Talent in the Pharmaceutical and Medical Device Industries Throughout the life science industry, pharmaceutical, bio-technology and medical device corporations are locked in what is often being coined a, “battle for talent…
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Aug |
2nd Annual Clinical Affairs & Regulatory Approvals For Diagnostics, September 12-13, 2011, Baltimore, MDCategory: Conferences | Leave a Comment |
Understanding Changes to FDA Regulatory Pathways and the Relative Evidentiary Requirements, Identifying Sample Size and Trial Design for Successful Submissions for Diagnostic Clinical Studies As diagnostic tests become more complex, offering faster, more effective and targeted testing opportunities for physicians and patients, the challenges in assuring regulatory approval…
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Aug |
2nd Annual European Diagnostic Reimbursement & Market Access Conference, September 5-6, 2011, Frankfurt, GermanyCategory: Conferences | Leave a Comment |
Recognizing the Nuances of Securing Funding for Diagnostic Tests in Europe through the Utilization of HTA’s, Alignment of Clinical Research & Reimbursement to Ensure Market Access & Working with Member States As diagnostic tests continue to evolve in their complexity and abundance, manufacturers face great challenges in finding support for these tests in an increasingly crowded marketplace…
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Aug |
Medical Device Regulatory Clearance & Approval Conference, September 12-13 2011, Baltimore, MDCategory: Conferences | Leave a Comment |
Providing Clarity & Definition to New & Existing FDA Regulatory Pathways to Ensure Medical Device Approvals in a Timely & Cost Efficient Manner There is no doubt that the medical device industry is currently experiencing greater regulatory scrutiny from the FDA; several very public instances of device failures & high profile recalls have resulted in the agency taking a muc…
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Aug |
Medical Device And Diagnostic Manufacturing Forum, September 18-20, 2011, San Antonio, TXCategory: Conferences | Leave a Comment |
Understanding Evolving Regulatory Guidance on a Global Level for Medical Devices & Diagnostic Tests, while Improving Facilities, Maintaining Compliance & Quality Control, and Reducing Costs in an Increasingly Competitive Environment As Medical Devices and Diagnostic Tests have increased in complexity, so have the manufacturing processes in place to safely and effectively p…