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CC2022: Evaluation of Commercially Available Knee ...
Evaluation of Commercially Available Knee Cartilag ...
Evaluation of Commercially Available Knee Cartilage Restoration Techniques Stratified by FDA Approval Pathway (November 2022)
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This study aimed to evaluate the levels of evidence in the literature supporting commercially available knee cartilage repair procedures, stratified by FDA regulatory pathway. The researchers hypothesized that products requiring stricter regulatory pathways would have higher levels of evidence supporting their use, and that products with less stringent regulatory pathways would have a higher number of available products in the US. The study conducted a systematic review of peer-reviewed articles related to knee cartilage repair technologies and analyzed variables such as publication year, type of publication, level of evidence, and number of publications. <br /><br />The results of the analysis showed that autologous chondrocyte implantation (ACI) and osteochondral allografts (OCA) had robust evidence supporting their use, while other regulated products had little to no supporting evidence. Products regulated under the stricter 351 HCT/P pathway (ACI) had a higher likelihood of clinical articles and more level 1 studies compared to products regulated under the 361 HCT/P pathway (OCA). Publications on 351 HCT/P technologies were also more likely to be published in high-impact journals. The number of publications for both pathways increased over time, with a peak in 2014 for 351 HCT/P and 2016 for 361 HCT/P.<br /><br />In conclusion, ACI and OCA have strong evidence supporting their use, while other FDA-approved products have limited evidence. Products regulated under the stricter pathway had higher levels of evidence and were more likely to be published in high-impact journals. The study suggests that more stringent regulatory pathways promote better scientific evidence, while less stringent pathways result in a higher number of available products. However, further investigation is needed for the newer 361 HCT/P products to determine their long-term outcomes and clinical applications.
Keywords
levels of evidence
knee cartilage repair procedures
FDA regulatory pathway
supporting evidence
autologous chondrocyte implantation
osteochondral allografts
351 HCT/P pathway
361 HCT/P pathway
high-impact journals
clinical applications
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