Keeping Up with Personalized Medicine: Adapting to Meet Patients ’ Needs

Medical technology is revolutionizing healthcare for patients worldwide and is now more than ever becoming crucial in the prevention, diagnosis, treatment, and management of numerous diseases. We are increasingly seeing the ability of medical technology to personalize treatments and target patients’ individual needs. However, to ensure we are enabling access to these treatments, regulatory agencies need to consider new approaches to the approval process. Historically, product approvals have focused on the standardization of a drug or a therapy to treat a large population of people with the same disease, safely and effectively. But in this new age of personalized care, these standards are insufficient for products coming to market that are designed to meet unique patient needs. Currently, regulatory agencies including FDA seek large clinical data sets to demonstrate that drug products are safe and effective for patients. While safety and efficacy need to be held to the highest standards for certain areas of healthcare, such as regenerative medicine, these data sets are both difficult and unnecessary to achieve. In cases where the patient population is small and varied, requiring large clinical trials creates needless challenges. Large clinical trials are very costly to run, difficult to recruit patients for, and often do not align with clinical endpoints for products that are intended to work individually for patients as opposed to a large population pool. Co...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Abstract The critical clinical and scientific insights achieved through knowledge of in vivo musculoskeletal soft tissue strains has motivated the development of relevant measurement techniques. This review provides a comprehensive summary of the key findings, limitations, and clinical impacts of these techniques to quantify musculoskeletal soft tissue strains during dynamic movements. Current technologies generally leverage three techniques to quantify in vivo strain patterns, including implantable strain sensors, virtual fibre elongation, and ultrasound. (1) Implantable strain sensors enable direct measurements ...
Source: Annals of Biomedical Engineering - Category: Biomedical Engineering Authors: Tags: Ann Biomed Eng Source Type: research
AbstractThe purpose of this study is to evaluate patient-reported outcome measures (PROMs) in patients aged 40  years and older who underwent meniscal repair or meniscectomy. All patients aged 40 and older who underwent a meniscal repair at a single institution from 2006 to 2017 were included. Meniscal repair cases were matched with a meniscectomy control group in a 1:3 ratio, selected for an equal proporti on of concomitant ACL reconstruction in each group. PROMs, collected at a minimum follow-up of 24 months, included International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Marx activi...
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
Publication date: Available online 15 September 2020Source: Arthroscopy TechniquesAuthor(s): Alexandra H. Aitchison, Lindsay M. Schlichte, Daniel W. Green, Frank A. Cordasco
Source: Arthroscopy Techniques - Category: Surgery Source Type: research
This study aims to compare the rate of meniscal tears after anterior cruciate ligament (ACL) reconstruction in patients who have undergone concomitant meniscal repair during the index procedure with that in patients who have not undergone such surgery. It also evaluates other risk factors, such as age, gender, race, body mass index (BMI), site of concomitant meniscal surgery, and ACL graft failure. This is a retrospective study conducted at a large tertiary public hospital. Patients who underwent primary anterior cruciate ligament reconstruction (ACLR) surgery with or without concomitant meniscal repair from 2011 to 2016 w...
Source: Journal of Knee Surgery - Category: Orthopaedics Authors: Tags: Original Article Source Type: research
Few studies have approached in a long-term follow-up of meniscal repair at an amateur level, specially studying variables as a quality of life and failure rate. The purpose of this review is to study medium to...
Source: Journal of Orthopaedic Surgery and Research - Category: Orthopaedics Authors: Tags: Research article Source Type: research
The purpose of this study is to evaluate how both annual surgeon and facility volume affect the cost and outcomes of ACLR surgery. We also aimed to identify trends in how surgeon caseload predicts graft selection.
Source: Arthroscopy - Journal of Arthroscopic and Related Surgery - Category: Surgery Authors: Source Type: research
When we were asked to be guest editors for this Foot and Ankle issue of Clinics in Sports Medicine, we appreciated the magnitude of this amazing opportunity to share the expertise of our Orthopedic Foot and Ankle community with our Sports Medicine colleagues around the country. Just as our Sports Medicine colleagues have revolutionized ACL reconstruction, cartilage regeneration, arthroscopy, and rotator cuff repair, our Foot and Ankle members have led the charge for advancing syndesmotic fixation, surgical treatment of ankle instability and turf toe injuries, tendon transfers for foot drop, and innovative approaches to fra...
Source: Clinics in Sports Medicine - Category: Sports Medicine Authors: Source Type: research
ConclusionsDistal hamstring tendon avulsion is a rare condition, with no consensus regarding optimal management options. Acute surgical repair leads to excellent results, with a return to pre-injury level of sporting activity.Level of evidenceIV.
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
ConclusionsAll-inside repair is a safe and versatile technique which can be used in the majority of meniscal tears encountered during ligament reconstruction with excellent mid-term success. Failure is seen more commonly in medial sided repairs and with failure of ACL reconstruction.Level of evidenceIV.
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
Conditions:   The ACL Rupture;   Meniscus Injury Intervention:   Procedure: Meniscus repair; partial meniscectomy Sponsor:   Peking University Third Hospital Completed
Source: - Category: Research Source Type: clinical trials
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