Post-approval studies in France, challenges facing medical devices.

Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance.

Effects of lumbar artificial disc design on intervertebral mobility: in vivo comparison between mobile-core and fixed-core.

Although in theory, the differences in design between fixed-core and mobile-core prostheses should influence motion restoration, in vivo kinematic differences linked with prosthesis design remained unclear. The aim of this study was to investigate the rationale that the mobile-core design seems more likely to restore physiological motion since the translation of the core could help to mimic the kinematic effects of the natural nucleus. In vivo intervertebral motion characteristics of levels implanted with the mobile-core prosthesis were compared with untreated levels of the same population, levels treated by a fixed-core prosthesis, and normal levels (data from literature). Patients had a single-level implantation at L4L5 or L5S1 including 72 levels with a mobile-core prosthesis and 33 levels with a fixed-core prosthesis. Intervertebral mobility characteristics included the range of motion (ROM), the motion distribution between flexion and extension, the prosthesis core translation (CT), and the intervertebral translation (VT). A method adapted to the implanted segments was developed to measure the VT: metal landmarks were used instead of the bony landmarks. The reliability assessment of the VT measurement method showed no difference between three observers (p < 0.001), a high level of agreement (ICC = 0.908) and an interobserver precision of 0.2 mm. Based on this accurate method, this in vivo study demonstrated that the mobile-core prosthesis replicated physiological VT at L4L5 levels but not at L5S1 levels, and that the fixed-core prosthesis did not replicate physiological VT at any level by increasing VT. As the VT decreased when the CT increased (p < 0.001) it was proven that the core mobility minimized the VT. Furthermore, some physiologic mechanical behaviors seemed to be maintained: the VT was higher at implanted the L4L5 level than at the implanted L5S1 level, and the CT appeared lower at the L4L5 level than at the L5S1 level. ROM and motion distribution were not different between the mobile-core prosthesis and the fixed-core prosthesis implanted levels. This study validated in vivo the concept that a mobile-core helps to restore some physiological mechanical characteristics of the VT at the implanted L4L5 level, but also showed that the minimizing effect of core mobility on the VT was not sufficient at the L5S1 level.

Radiological analysis of 37 segments in cervical spine implanted with a peek stand-alone device, with at least one year follow-up.

BACKGROUND: High incidence of subsidence in cervical stand-alone cages was reported in the literature. PURPOSE: The goal of this study was to assess the radiological outcomes of a PEEK anchored stand-alone cage (MC+®) with a minimum of 1 year follow-up. STUDY DESIGN: A retrospective radiological evaluation. PATIENT SAMPLE: The study was conducted in 4 hospitals and involved 28 patients (37 levels) treated by ACDF (Anterior Cervical Discectomy and Fusion) for spondylotic radiculopathy and/or myelopathy. OUTCOME MEASURES: We analyzed fusion, disc height, cage or anchor micro plate migration, discal and segmental lordosis and subsidence. METHODS: All the patients were controlled at least one year after surgery with an average of 31 months. Antero-posterior and lateral X-rays were performed pre-operatively, immediate post-operatively, and at final follow up. The different radiographic measurements were performed with the assistance of software (SpineView®). CT-scans were performed for each case at final follow-up to assess the fusion. RESULTS: No migration or breakage was reported for either the cage or the anchor micro plate. The fusion rate was 94.1% at the final follow-up. No subsidence was observed. The disc height increased between preop and final follow-up from 23.3% to 44.3%, from 22.1% to 35.1% and from 38.3% to 51.5% for anterior, posterior and midline disc height respectively. Mean Functional Spinal Unit Lordosis increased from 0.9° preop to 3.0° at final follow-up. No new kyphotic situation could be noticed. At the final follow-up, 96% of the patients stated they would undergo the procedure again. CONCLUSION: With a high rate of proven fusion, restoration of disc height and spinal alignment in most cases, and absence of subsidence or migration, our radiological results with MC+® at more than 1 year of follow-up show the implanted device to be safe and effective for use in treating degenerative conditions of the cervical spine.

Does core mobility of lumbar total disc arthroplasty influence sagittal and frontal intervertebral displacement? Radiologic comparison with fixed-core prosthesis.

BACKGROUND: An artificial disc prosthesis is thought to restore segmental motion in the lumbar spine. However, it is reported that disc prosthesis can increase the intervertebral translation (VT). The concept of the mobile-core prosthesis is to mimic the kinematic effects of the migration of the natural nucleus and therefore core mobility should minimize the VT. This study explored the hypothesis that core translation should influence VT and that a mobile core prosthesis may facilitate physiological motion. METHODS: Vertebral translation (measured with a new method presented here), core translation, range of motion (ROM), and distribution of flexion-extension were measured on flexion-extension, neutral standing, and lateral bending films in 89 patients (63 mobile-core [M]; 33 fixed-core [F]). RESULTS: At L4-5 levels the VT with M was lower than with F and similar to the VT of untreated levels. At L5-S1 levels the VT with M was lower than with F but was significantly different compared to untreated levels. At M levels a strong correlation was found between VT and core translation; the VT decreases as the core translation increases. At F levels the VT increases as the ROM increases. No significant difference was found between the ROM of untreated levels and levels implanted with either M or F. Regarding the mobility distribution with M and F we observed a deficit in extension at L5-S1 levels and a similar distribution at L4-5 levels compared to untreated levels. CONCLUSION: The intervertebral mobility was different between M and F. The M at L4-5 levels succeeded to replicate mobility similar to L4-5 untreated levels. The M at L5-S1 succeeded in ROM, but failed regarding VT and mobility distribution. Nevertheless M minimized VT at L5-S1 levels. The F increased VT at both L4-5 and L5-S1. CLINICAL RELEVANCE: This study validates the concept that the core translation of an artificial lumbar disc prosthesis minimizes the VT.