Initial American experience with hip resurfacing following FDA approval.
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ABSTRACT:
SUBMITTER: Della Valle CJ
PROVIDER: S-EPMC2600981 | biostudies-other | 2009 Jan
REPOSITORIES: biostudies-other
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Project description:BackgroundHip resurfacing is an alternative to total hip arthroplasty.Questions/purposeWe aimed to compare an experienced hip surgeon's initial clinical results of hip resurfacing with a new cementless total hip arthroplasty (THA).MethodsThe first 55 consecutive hip resurfacing arthroplasties were compared to 100 consecutive cementless THAs using a cylindrical tapered femoral stem. The learning curve between the two procedures was compared utilizing the incidence of reoperation, complications, Harris Hip Scores (HHS), and implant survivorship.ResultsThe reoperation rate was significantly higher (p?=?0.019) for hip resurfacing (14.5%) versus THA (4%). The overall complication rate between the two groups was not significantly different (p?=?0.398). Preoperative HHS were similar between the two groups (p?=?0.2). The final mean HHS was similar in both the resurfacing and THA groups (96 vs. 98.3, respectively, p?<?0.65). Kaplan-Meier survival analysis with an endpoint of reoperation suggests complications occurred earlier in the resurfacing group versus the THA group (log-rank test, p?=?0.007).ConclusionsIn comparison to our initial experience with a cementless THA stem, operative complications occur earlier and more often after hip resurfacing during the learning period. The clinical outcomes in both groups however are similar at 5 year follow-up.
| S-EPMC3757479 | biostudies-literature
Project description:BackgroundThe FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation.Questions/purposesWe asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices?MethodsAll original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed.ResultsSeventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and 2014. These devices included 34 peripheral joint implants or prostheses, 18 spinal implants or prostheses, and 18 other devices or materials. These devices underwent a median 6.5 postmarket changes during their lifespan or 1.0 changes per device-year (interquartile range, 0.4-1.9). The rate of new postmarket device changes approved per active device, increased from less than 0.5 device changes per year in 1983 to just fewer than three device changes per year in 2014, or an increase of 0.05 device changes per device per year in linear regression analysis (95% CI, 0.04-0.07). Among the 765 total postmarket changes, 172 (22%) altered device design or components. The majority of the design changes were reviewed via either the real-time review track (n = 98; 57%), intended for minor design changes, or the 180-day review track (n = 71; 41%), intended for major design changes. Finally, a total of 12 devices had FDA recalls at some point during their lifespan, two being for hip prostheses with high revision rates.ConclusionsRelatively few orthopaedic devices undergo the FDA PMA process before reaching the market. Orthopaedic surgeons should be aware that high-risk medical devices cleared via the FDA's PMA pathway do undergo considerable postmarket device modification after reaching the market, with potential for design "drift," ie, shifting away from the initially tested and approved device designs.Clinical relevanceAs the ultimate end-users of these devices, orthopaedic surgeons should be aware that even among high-risk medical devices approved via the FDA's PMA pathway, considerable postmarket device modification occurs. Continued postmarket device monitoring will be essential to limit patient safety risks.
| S-EPMC4773325 | biostudies-literature
Project description:Background and purposeHip resurfacing arthroplasty is claimed to allow higher activity levels and to give better quality of life than total hip arthroplasty. In this literature review, we assessed the therapeutic value of hip resurfacing arthroplasty as measured by functional outcome.MethodsAn extensive literature search was performed using the PubMed, Embase, and Cochrane databases.Results9 patient series, 1 case-control study, and 1 randomized controlled trial (RCT) were included. Clinically and statistically significant improvement in sporting activity and hip scores were found in 10 studies.InterpretationStudies with low levels of evidence have shown improvement in various different hip scores and one RCT showed better outcomes with hip resurfacing arthroplasty. There is no high-level evidence to prove that there is improved clinical outcome using hip resurfacing arthroplasty. More randomized research needs to be done.
| S-EPMC3216077 | biostudies-literature
Project description:The purpose of our study was to prospectively report the clinical results of 280 consecutive hips (240 patients) who received a ReCap Hip Resurfacing System implant (Biomet Inc., Warsaw, USA) in a single district general hospital. Literature reports a large variation in clinical results between different resurfacing designs and published results using this particular design are scarce.Mean follow up was 3.3 years (1.0 to 6.3) and four patients were lost to follow-up. All patients were diagnosed with end-stage hip osteoarthritis, their mean age was 54 years and 76.4% of all patients were male.There were 16 revisions and four patients reported a Harris Hip Score <70 points at their latest follow up. There were no pending revisions. Kaplan-Meier implant survival probability, with revision for any reason as endpoint, was 93.5% at six years follow-up (95%-CI: 88.8-95.3). There were no revisions for Adverse Reactions to Metal Debris (ARMD) and no indications of ARMD in symptomatic non-revised patients, although diagnostics were limited to ultrasound scans.This independent series confirms that hip resurfacing is a demanding procedure, and that implant survival of the ReCap hip resurfacing system is on a critical level in our series. In non-revised patients, reported outcomes are generally excellent.ClinicalTrials.gov Identifier: NCT00603395.
| S-EPMC3529103 | biostudies-literature
Project description:BackgroundThe hip resurfacing concept was developed for young and active patients, especially for femoral bone stock preservation. However, concerns about metal-on-metal bearings with adverse reactions to metal debris have led to a drop off in hip-resurfacing procedures.Questions/purposesThe goal of this review is to evaluate our current knowledge of survivorship of second-generation hip resurfacing devices and elaborate international perspectives for product improvement.MethodsA comprehensive literature search provided information on national joint arthroplasty registers worldwide with a minimum of 3000 reported hip resurfacings. It culminated in the analysis of six registers.ResultsLong-term data showed that available hip resurfacing device survivorship ranged from 95 to 99.7% with 10 years of follow-up, in selected patient populations. The criteria for success were well known, male gender, good bone quality, head component size greater than 48 mm, and cup inclination less than 45°. On the other hand, the recent recall of some hip-resurfacing devices has resulted in huge medico-legal problems and has discredited all implants. It has brought about the recent evolution of hip resurfacing. Femoral fixation is now available for cemented and cementless surfaces. Bearings are still always metal-on-metal, but new types have come on board. Newer designs suggest that ceramic-on-ceramic, cross-linked polyethylene, and oxinium may be applied in this configuration.ConclusionsIn 2015, the evolution of hip resurfacing is ongoing in terms of implant design, alternative bearings, and implant fixation with hopes of improving survivorship.
| S-EPMC5264568 | biostudies-literature
Project description:BackgroundPrevious research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit.ObjectivesTo examine the clinical trial evidence supporting new targeted cancer drugs' initial and supplementary indication approval in the US, EU, Canada, and Australia.Data and methods25 cancer drugs across 100 indications were identified with FDA approval between 2009-2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ2-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI).ResultsOut of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07-6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38-8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17-5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14-30.65], p < 0.05) than supplementary indications. Initial indications' pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93-0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09-0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01-1.39], p < 0.05).ConclusionsTargeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication's differential clinical and economic value.
| S-EPMC9288371 | biostudies-literature
Project description:Background: In February 2009, the US Food and Drug Administration (FDA) granted Humanitarian Device Exemption (HDE) for deep brain stimulation (DBS) in the anterior limb of the internal capsule (ALIC) for the treatment of severely debilitating, treatment refractory obsessive-compulsive disorder (OCD). Despite its promise as a life altering treatment for patients with otherwise refractory, severely debilitating OCD, the use of DBS for the treatment of OCD has diminished since the FDA HDE endorsement and is now rarely performed even at busy referral centers. We sought to identify factors hindering OCD patients from receiving DBS therapy. Materials and Methods: University of Florida (UF) clinical research databases were queried to identify patients evaluated as potential candidates for OCD DBS from January 1, 2002 to July 30, 2020. A retrospective review of these patients' medical records was performed to obtain demographic information, data related to their OCD, and details relevant to payment such as third-party payer, study participation, evaluation prior to or after HDE approval, and any stated factors prohibiting surgical intervention. Results: Out of 25 patients with severe OCD identified as candidates for DBS surgery during the past 18 years, 15 underwent surgery. Prior to FDA HDE approval, 6 out of 7 identified candidates were treated. After the HDE, only 9 out of 18 identified candidates were treated. Seven of the 9 were funded by Medicare, 1 paid out of pocket, and 1 had "pre-authorization" from her private insurer who ultimately refused to pay after the procedure. Among the 10 identified OCD DBS candidates who were ultimately not treated, 7 patients-all with private health insurance-were approved for surgery by the interdisciplinary team but were unable to proceed with surgery due to lack of insurance coverage, 1 decided against surgical intervention, 1 was excluded due to medical comorbidities and excessive perceived surgical risk, and no clear reason was identified for 1 patient evaluated in 2004 during our initial NIH OCD DBS trial. Conclusion: Based on compelling evidence that DBS provides substantial improvement of OCD symptoms and markedly improved functional capacity in 2 out of 3 patients with severely debilitating, treatment refractory OCD, the FDA approved this procedure under a Humanitarian Device Exemption in 2009, offering new hope to this unfortunate patient population. A careful review of our experience with OCD DBS at the University of Florida shows that since the HDE approval, only 50% of the severe OCD patients (9 of 18) identified as candidates for this potentially life altering treatment have been able to access the therapy. We found the most common limiting factor to be failure of private insurance policies to cover DBS for OCD, despite readily covering DBS for Parkinson's disease, essential tremor, and even dystonia-another HDE approved indication for DBS. We have identified an inherent discrimination in the US healthcare system against patients with medication-refractory OCD who are economically challenged and do not qualify for Medicare. We urge policy makers, insurance companies, and hospital administrations to recognize this health care disparity and seek to rectify it.
| S-EPMC7994854 | biostudies-literature
Project description:The US Food and Drug Administration (FDA) approved 5-aminolevulinic acid (5-ALA; Gleolan®; photonamic GmbH and Co. KG) for use as an intraoperative optical imaging agent in patients with suspected high-grade gliomas (HGGs) in 2017. This was the first ever optical imaging agent approved as an adjunct for the visualization of malignant tissue during surgery for brain tumors. The approval occurred a decade after European approval and a multicenter, phase III randomized trial which confirmed that surgeons using 5-ALA fluorescence-guided surgery as a surgical adjunct could achieve more complete resections of tumors in HGG patients and better patient outcomes than with conventional microsurgery. Much of the delay in the US FDA approval of 5-ALA stemmed from its conceptualization as a therapeutic and not as an intraoperative imaging tool. We chronicle the challenges encountered during the US FDA approval process to highlight a new standard for approval of intraoperative optical imaging agents in brain tumors.
| S-EPMC6445645 | biostudies-literature
Project description:BackgroundFemoroacetabular impingement and degenerative hip osteoarthritis (OA) affect athletes across a wide variety of sports. Hip resurfacing arthroplasty (HRA) has emerged as a surgical treatment for active individuals with end-stage hip OA to provide pain relief and allow return to high-impact activities. Return to professional sports after HRA has not been well characterized.Purpose/hypothesisThe aim of this study was to report on a series of elite athletes in a variety of sports who underwent HRA. We hypothesized that professional and elite-level athletes would be able to return to sports after HRA for end-stage hip OA.Study designCase series; Level of evidence, 4.MethodsA retrospective case series was conducted on professional athletes who underwent HRA at a single institution between 2007 and 2017. All surgeries were performed by a single surgeon using the posterolateral approach. Athletes' return to play and sport-specific performance statistics were obtained using self-reported and publicly available data sources. Athletes were matched to an age- and performance-based cohort to determine changes in performance-based metrics.ResultsEight professional athletes were identified, including 2 baseball pitchers, 1 ice hockey defenseman, 1 foil fencer, 1 men's doubles tennis player, 1 basketball player, 1 ultramarathoner, and 1 Ironman triathlete. All 8 patients returned to sports; 6 of 8 (75%) patients were able to return for at least 1 full season at a professional level after surgery. There were no significant differences between performance statistics for athletes who returned to play and their preoperative performance measures for the years leading up to surgery or the age- and performance-matched cohort.ConclusionHRA remains a surgical alternative for end-stage hip OA in young, high-impact, active patients. While the primary goals of surgery are pain control and quality of life improvement, it is possible to return to elite-level sporting activity after HRA.
| S-EPMC8113959 | biostudies-literature
Project description: Not available
| S-EPMC6583530 | biostudies-literature