相关临床试验
8
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
1
12.5%
招募中
1
12.5%
Unknown
6
75.0%
暂无批准数据
- A large-scale analysis of 1,626 cervical disc replacement patients found an implant removal or revision rate of 1.48%, providing a long-sought benchmark comparable to hip and knee replacement data. - Osteolysis emerged as the leading cause of revision, with certain implant designs—including the withdrawn M6 disc and PEKK-based ceramic implants—showing higher incidence than traditional cobalt-chrome devices. - Long-term data show cervical disc replacement reduces adjacent-level reoperation by roughly 4 percentage points at 10 years compared to fusion, a far smaller benefit than originally anticipated. - Experts emphasize that patient selection—evaluating bone quality, spinal canal dimensions, and compressive pathology—is critical, as poor candidates face risks of implant subsidence, persistent compression, and complex revision surgeries.
- Northwestern Medicine and Scripps Health have enrolled their first patients in Aclarion's pivotal CLARITY trial, bringing the total number of active enrollment sites to four out of seven approved centers. - The multi-site trial aims to evaluate whether Nociscan technology can improve surgical outcomes beyond the current 54% industry benchmark for chronic low back pain surgery patients. - The company targets enrolling 25% of the planned 300 patients by Q2 2026, with initial interim data readout expected in Q3 2026 after the first cohort completes 3-month follow-up visits.
- UHealth-University of Miami Health System has enrolled the first two patients in Aclarion's pivotal CLARITY trial, testing Nociscan technology for chronic low back pain surgical outcomes. - The randomized 300-patient study evaluates whether Nociscan's MR spectroscopy and AI algorithms can improve spine surgery results by identifying painful disc sources. - The multi-center trial includes major medical institutions and aims to demonstrate clinical and economic value, with interim results expected in Q2 2026.
- Dymicron received FDA Investigational Device Exemption (IDE) approval to begin a pivotal clinical trial of its Triadyme-C cervical artificial disc for degenerative disc disease treatment. - The device features proprietary Adymite polycrystalline diamond bearing surfaces designed to dramatically reduce wear debris generation compared to conventional implant materials. - The multi-center trial will compare Triadyme-C to anterior cervical discectomy and fusion surgery, with first implantations expected in Q4 2025. - The tri-lobed design is engineered to closely replicate normal spinal kinematics, potentially improving long-term patient outcomes.
- Curiteva secured FDA 510(k) clearance for the Inspire Trabecular PEEK Standalone ALIF system, marking the first-ever 3D printed PEEK standalone implant with HAFUSE technology. - The implant features fully integrated porosity, exceptional radiographic visibility, and optimal biomechanical properties engineered to promote osseointegration across the entire construct. - Dr. Stephen Tolhurst from Texas Back Institute reported striking results over two years of use, with visual confirmation of bone growth both on and through the implant. - The rapid regulatory approval was facilitated by Curiteva's proprietary FDA Master File for Inspire technology, building on previous success with the Inspire Lumbar Interbody clearance.
- Keck Medical Center of USC has joined the CLARITY trial to evaluate Aclarion's Nociscan technology, which uses MR Spectroscopy and AI to identify sources of chronic low back pain. - The randomized, multi-center CLARITY trial will enroll 300 patients across prestigious institutions including Johns Hopkins Medicine, Northwestern Medicine, and Texas Back Institute. - Nociscan is the first evidence-supported platform to noninvasively distinguish between painful and nonpainful discs in the lumbar spine, potentially transforming diagnosis and treatment for 266 million people worldwide with degenerative spine disease.
