The first knee prosthesis to go through beyond compliance: A new standard for the safe introduction of orthopaedic implants.

INTRODUCTION: Beyond Compliance (BC) was introduced in 2012 to improve the monitoring and regulation of new medical devices and techniques, ensuring patient safety whilst promoting innovation through an evidence based appraisal of devices during their introduction. This study reports the 2 year outcomes of the first Total Knee Replacement (TKR) implant to be assessed through the BC process. METHODS: 100 consecutive patients undergoing primary knee arthroplasty were enrolled. All patients received a single radius cruciate retaining TKA (Unity, Corin), and the patella was resurfaced in all cases. Patients were followed up at 6 weeks, 3, 6, 12 and 24 months post operatively. Pre-and post-operative range of movement (ROM) as well as outcome scores including OKS, KOOS, EQ5D index and EQ5D VAS were recorded. RESULTS: 100 patients with a mean age 73.6 (SD = 8.7) were included. 2 patients died during the follow-up period due to unrelated reasons. Overall satisfaction rates were 96%. Complications included ongoing pain (5 patients), and a periprosthetic fracture (1 patient) nine months post-surgery (traumatic). No knees were revised during the follow-up period. Significant improvements were observed in all outcomes measures (OKS, KOOS, EQ5D, and EQ5D VAS). The mean added ROM was 13.2°. DISCUSSION: This knee prosthesis has been demonstrated to be safe and effective with excellent early outcomes. The careful regulated introduction of this device through BC has ensured patients safety while supporting innovation in knee arthroplasty. The success of BC requires surgeons to insist industry fully engage with the process for all new devices or techniques.

CARD9 in the pathogenesis of axial spondyloarthritis.

Axial spondyloarthritis (axSpA) has been long classified as an autoimmune disease caused by a breakdown in the ability of the immune system to delineate self from foreign, resulting in self-reactive T cells. The strong genetic association of HLA-B27 supports this role for T cells. More recently, genetic and clinical studies indicate a prominent role of the environment in triggering axSpA, including an important role for microbes and the innate immune response. As an example, mutations in genes associated with innate immunity, including the anti-fungal signaling molecule Caspase recruitment domain-containing protein 9 (CARD9), have been linked to axSpA susceptibility. Thus, current thought classifies axSpA as a "mixed pattern condition" caused by both autoimmune and autoinflammatory mechanisms. The goal of this review is to convey.

Modifiable factors delaying early discharge following primary joint arthroplasty.

AIMS: Recent NHS reforms have incentivised reduction in length of stay, with the UK department of health expecting health trusts to reduce bed days and ultimately reduce overall costs. The aim of this study was to identify avoidable causes for protracted hospital admission following total hip arthroplasty (THA) or total knee arthroplasty (TKA) within a fast-track unit. METHODS: During a 6-month period, 535 consecutive patients underwent primary THA or TKA under the care of a single surgeon. All patients with a post-operative stay of greater than 72 h were identified, and reasons for delayed discharge were determined. RESULTS: The majority of arthroplasty patients were discharged within 3 days post-operatively. Twenty-one per cent of THA patients and 25 % of TKA patients remained as inpatients for greater than 72 h. For the THA population, this equates to 43 % of bed days used by 21 % of patients, and for the TKA population, 44 % of bed days were used by 25 % of patients. The major factor within both groups for delayed discharge was attributed to inadequate social support. CONCLUSIONS: Delayed discharge can never be totally prevented. This unit aims to develop improvement in social work provision, with a greater focus on pre-admission discharge planning to reduce the number of delayed discharges and ultimately reduce the cost burden of joint replacement surgery. It is not conducive with the ethos of fast-track arthroplasty to only identify social circumstances upon admission.

Diagnosis of vertebral fractures in post-ictal patients.

The violent forces generated by the strong paraspinal muscles during generalised tonic-clonic seizures are known to be associated with numerous musculoskeletal injuries. Vertebral fractures following epileptic seizures are typically compression fractures, occurring in the mid thoracic region, usually without resultant neurological deficit. Despite the relative frequency of vertebral compression fractures complicating tonic-clonic seizures, burst fractures are rare. We report a case of a burst fracture resulting in conus medullaris syndrome following generalised motor seizures. Clinicians managing post-ictal patients should maintain a high degree of suspicion for secondary injury and conduct a detailed clinical examination. If there remains any doubt regarding diagnosis, appropriate imaging should be employed.

The influence of immediate knee flexion on blood loss and other parameters following total knee replacement.

In an initial randomised controlled trial (RCT) we segregated 180 patients to one of two knee positions following total knee replacement (TKR): six hours of knee flexion using either a jig or knee extension. Outcome measures included post-operative blood loss, fall in haemoglobin, blood transfusion requirements, knee range of movement, limb swelling and functional scores. A second RCT consisted of 420 TKR patients randomised to one of three post-operative knee positions: flexion for three or six hours post-operatively, or knee extension. Positioning of the knee in flexion for six hours immediately after surgery significantly reduced blood loss (p = 0.002). There were no significant differences in post-operative range of movement, swelling, pain or outcome scores between the various knee positions in either study. Post-operative knee flexion may offer a simple and cost-effective way to reduce blood loss and transfusion requirements following TKR. We also report a cautionary note regarding the potential risks of prolonged knee flexion for more than six hours observed during clinical practice in the intervening period between the two trials, with 14 of 289 patients (4.7%) reporting lower limb sensory neuropathy at their three-month review.

Intra-operative and short term outcome of total knee arthroplasty in morbidly obese patients.

BACKGROUND: Longer operation times, poorer patient outcomes and increased early post-operative complications are reasons cited for not undertaking total knee arthroplasty (TKA) on morbidly obese patients. This study tests the hypothesis that there is no difference in intra-operative parameters between morbidly obese and non-obese patients, and no difference in patient outcome. METHODS: Intra-operative parameters, post-operative complications, patient outcomes and knee range of motion were compared between morbidly obese patients (BMI>40 kg/m2) and individually age and gender matched non-obese patients (BMI<30 kg/m2) undergoing cementless rotating platform TKA. RESULTS: Anaesthetic times and length of hospital stay were not significantly different between the morbidly obese and non-obese patients. Surgical time was significantly greater in morbidly obese patients. Improvements in patient outcomes following TKA were not significantly different between the morbidly obese and non-obese patients at early and short-term follow-up. CONCLUSIONS: In contrast to previous studies, post-operative complication rates within three months of surgery and up to one year post-operatively were not significantly higher for morbidly obese patients. LEVEL OF EVIDENCE: III.