Abstract

MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods.

Cite this article: Bone Jt Open 2022;3(2):155–157.

Most spinal pedicle fixation systems used in this country are imported and expensive. They mostly employ rigid or semi-rigid screws with a known and significant rate of implant failure. Though they are often designed for ease of insertion, many are difficult to remove. This study investigated the radiological outcome of a dynamic spinal fixation system developed in South Africa with the aims of reducing costs, improving ease of insertion and removal, reducing the rate of implant failure, and at the same time meeting international standards. A University Ethics Committee approved this study of 439 patients in whom the device was used in spinal surgery between 1997 and 2002. Of these patients, 121 had follow-up radiographs taken more than one year after surgery. These radiographs were independently reviewed and form the basis of this study. In 93.4% of patients, the fusion was radiographically solid. The state of fusion was uncertain in 4.1%, and fusion had failed in 2.5%. Screw breakage occurred in 0.3%. There were no rod breakages. In 1% of patients there was evidence of screw-bone loosening. There were no signs of screw-rod breakage or loosening. The device produces a satisfactory rate of fusion with a very low rate of implant failure. Awarded ISO 9001:2001 certification and the CE mark, it meets international standards at considerably reduced cost

Dislocations remain a significant problem, especially after revision hip surgery. Revision of components, particularly in elderly patients with co-morbidities, can be fraught with complications. The surgeon’s options are sometimes restricted, particularly when the acetabular and femoral components are well fixed. Increased head lengths are often utilised to increase tissue tension, and thus improve stability. As a niche solution we have designed a low cost modular femoral neck extender. They are manufactured from medical grade Cobalt-Chrome, conforming to ISO 200, CE mark and EN46001 standards. Available in three incremental lengths and with different connecting Morse tapers, increases in effective neck lengths of up to 49 mms can be achieved. When both the original acetabular and femoral components are well orientated, the resultant increased tissue tension imparts stability to the hip. We present a series of five patients where we have used a femoral neck extender to achieve stability of a total hip replacement. Four patients had had multiple previous dislocations. One patient was unstable at the time of revision surgery because of a high hip centre. The average age of the patients was 72 years, and the number of previous dislocations averaged four. The average follow-up after surgery was 22 months. No patients have redislocated their hips. We present our novel femoral neck extenders as an elegant and cost effective solution to convert an unstable hip to a stable hip, especially when the patient has well fixed and orientated components not in themselves requiring revision

Dislocations remain a significant problem, especially after revision hip surgery. Revision of components, particularly in elderly patients with co-morbidities, can be fraught with complications. The surgeon’s options are sometimes restricted, particularly when the acetabular and femoral components are well fixed. Increased head lengths are often utilized to increase tissue tension, and thus improve stability. As a niche solution we have designed a low cost modular femoral neck extender. They are manufactured from medical grade Cobalt-Chrome, conforming to ISO 200, CE mark and EN46001 standards. Available in 3 incremental lengths and with different connecting Morse tapers, increases in effective neck lengths of up to 49 mm can be achieved. When both the original acetabular and femoral components are well orientated, the resultant increased tissue tension imparts stability to the hip. We present a series of 5 patients where we have used a femoral neck extender to achieve stability of a total hip replacement. 4 patients had had multiple previous dislocations. 1 patient was unstable at the time of revision surgery because of a high hip centre. The average age of the patients was 72 years, and the number of previous dislocations averaged 4. The average follow-up after surgery was 22 months. No patients have redislocated their hips. We present our novel femoral neck extenders as an elegant and cost effective solution to convert an unstable hip to a stable hip, especially when the patient has well fixed and orientated components not in themselves requiring revision

Aims

Orthopaedic surgery requires grafts with sufficient mechanical strength. For this purpose, decellularized tissue is an available option that lacks the complications of autologous tissue. However, it is not widely used in orthopaedic surgeries. This study investigated clinical trials of the use of decellularized tissue grafts in orthopaedic surgery.

Aims

Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations.

Joint replacement of the hip and knee remain very satisfactory operations. They are, however, expensive. The actual manufacturing of the implant represents only 30% of the final cost, while sales and marketing represent 40%. Recently, the patents on many well established and successful implants have expired. Companies have started producing and distributing implants that purport to replicate existing implants with good long-term results.

The aims of this paper are to assess the legality, the monitoring and cost saving implications of such generic implants. We also assess how this might affect the traditional orthopaedic implant companies.

Cite this article: Bone Joint J 2016;98-B:892–900.

Aims

The aim of this study was to determine how the short- and medium- to long-term outcome measures after total disc replacement (TDR) compare with those of anterior cervical discectomy and fusion (ACDF), using a systematic review and meta-analysis.

Objectives

High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA).

This review examines the future of total hip arthroplasty, aiming to avoid past mistakes

New brands of joint prosthesis are released for general implantation with limited evidence of their long-term performance in patients. The CUSUM continuous monitoring method is a statistical testing procedure which could be used to provide prospective evaluation of brands as soon as implantation in patients begins and give early warning of poor performance. We describe the CUSUM and illustrate the potential value of this monitoring tool by applying it retrospectively to the 3M Capital Hip experience.

The results show that if the clinical data and methodology had been available, the CUSUM would have given an alert to the underperformance of this prosthesis almost four years before the issue of a Hazard Notice by the Medical Devices Agency. This indicates that the CUSUM can be a valuable tool in monitoring joint prostheses, subject to timely and complete collection of data. Regional or national joint registries provide an opportunity for future centralised, continuous monitoring of all hip and knee prostheses using these techniques.