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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With great interest, we read the article by Chahla et al., “Anterior cruciate ligament repair versus reconstruction: A kinematic analysis”, published in the December 2019 issue of The Knee [1]. In this biomechanical study, in the human cadaveric knee, the authors concluded that both augmented anterior cruciate ligament suture repair (ACLSR) and anterior cruciate ligament (ACL) reconstruction restored anterior tibial translation to native ACL values at time zero, but that further clinical studies are needed to compare long-term stability.
Source: The Knee - Category: Orthopaedics Authors: Source Type: research
The objective and subjective outcomes at 2  years are presented.MethodsPaediatric patients, less than 16  years of age, presenting acutely with complete proximal ACL ruptures underwent direct arthroscopic ACL repair, reinforced by a temporary internal brace, which was subsequently removed after 3 months. Patient-reported outcome measures including the Lysholm, Tegner and KOOS scores were collected at 6 months, 1 year and 2 years post-operatively.ResultsTwenty patients (age 6 –16) completed data at 2 years post-operatively. There were no failures, no complications and no growth distu...
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
We describe a technique combining the advantages of both techniques with an autograft using the semitendinosus and repair of the remnant. This combined technique allows protection and redirection of the remnant, improves graft incorporation, and covers more graft by suturing the remnant around an autologous graft.
Source: Arthroscopy Techniques - Category: Surgery Source Type: research
Authors: Spang RC, Getgood A, Strickland SM, Amendola AN, Gomoll AH Abstract This review focuses on the management of anterior cruciate ligament (ACL) reconstruction patients when other concomitant pathology may need to be addressed at the time of surgery. Given the role of the posterior horn of the medial meniscus in preventing osteoarthritis progression and contributing to knee stability, medial meniscus repair should always be considered when performing ACL reconstruction. Meniscal transplant may also be appropriate in select patients with normal knee alignment and absent of cartilage abnormalities in the compar...
Source: Instructional Course Lectures - Category: Orthopaedics Tags: Instr Course Lect Source Type: research
J Knee Surg DOI: 10.1055/s-0040-1701220Lateral extraarticular procedures (LEAPs) in the anterior cruciate ligament (ACL)-injured knee were widely abandoned in the 1990s but have seen a recent resurgence. The aim of this review was to demonstrate that anterolateral ligament reconstruction (ALLR) is associated with evidence of significant advantages and no evidence of historical concerns. A narrative review of the literature was performed. Combined ACL + ALLR is associated with improved outcomes when compared against isolated ACL reconstruction, including a significantly lower risk of ACL graft rupture (hazard ...
Source: Journal of Knee Surgery - Category: Orthopaedics Authors: Tags: Original Article Source Type: research
ConclusionThe progression of post-traumatic chondral damage may occur at a faster rate in patients who require ACL reconstruction and meniscal repair than in patients with intact menisci.
Source: Asia-Pacific Journal of Sports Medicine, Arthroscopy, Rehabilitation and Technology - Category: Sports Medicine Source Type: research
ConclusionThe minimum 5  years survival rate after primary ACL repair using this technique was 70%. This value dropped to 56% in highly active patients performing competitive sports. Patients not suffering failure of repair demonstrated adequate restoration of knee laxity and high satisfaction. This study not only underli nes the potential of ACL repair, but also highlights the danger of the procedure if strict patient selection is not appreciated.Level of evidenceLevel IV.
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
CONCLUSION: A well-designed database and user-friendly interface have greater potential for research utility, clinical efficiency, and, thus, cost-effectiveness when compared with standard voice-dictated operative notes. Widespread utilization of such tools can accelerate the pace and improve the quality of orthopaedic clinical research. LEVEL OF EVIDENCE: Level IV. PMID: 31977610 [PubMed - in process]
Source: The Journal of the American Academy of Orthopaedic Surgeons - Category: Orthopaedics Tags: J Am Acad Orthop Surg Source Type: research
Conclusion: The patients treated with QT autograft had clinical results and post-operative pain similar to those of patients treated with HT autograft for ACL reconstruction. PMID: 31967599 [PubMed - in process]
Source: Cirugia y Cirujanos - Category: Surgery Authors: Tags: Cir Cir Source Type: research
CONCLUSIONS Anterior cruciate ligament suture with the InternalBrace ligament augmentation judging from the results achieved by our group of patients brings very good clinical outcomes already at 6 months postoperatively. This method allows the athletes to return to full load soon. It maintains the kinematics and knee joint proprioception, and thus can potentially contribute to the prevention of post-traumatic arthritis. Strict application of indication criteria is a precondition to success. A longer follow up and evaluation of a larger number of patients will, however, be necessary to definitely confirm the success of thi...
Source: Acta Chirurgiae Orthopaedicae et Traumatologiae Cechoslovaca - Category: Orthopaedics Tags: Acta Chir Orthop Traumatol Cech Source Type: research
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