Effectiveness and cost-effectiveness of radiofrequency denervation versus placebo for chronic and moderate to severe low back pain: study protocol for the RADICAL randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking. METHODS AND ANALYSIS: RADICAL (RADIofrequenCy denervAtion for Low back pain) is a double-blind, parallel-group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention to treat and will follow a prespecified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality-adjusted life-year and incremental net benefit of RFD over the 2-year follow-up period. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open-access publications and plain language summaries. TRIAL REGISTRATION NUMBER: ISRCTN16473239.

Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients.

INTRODUCTION: Extensive blood loss related to knee arthroplasty is quite normal and many patients require blood transfusions. Surgery and the use of pneumatic tourniquets lead to an increase in the activity of the fibrinolytic system, which in turn may accentuate the blood loss. Drugs that inhibit the fibrinolytic system may thus be used to reduce blood loss. Tranexamic acid (TA) acts by binding to one of the enzymes at the start of the coagulation cascade, so inhibiting the fibrinolytic system. A concern is that this inhibition may have the side effect of increasing thromboembolic disease, a common complication of joint replacement surgery. We aimed to confirm the reductions in blood loss and to assess the impact of TA usage on clinical and sub-clinical DVT. METHOD: We performed a prospective, randomised, double blind, controlled trial, using patients due to undergo primary unilateral total knee arthroplasty. Patients were randomised to receive either 15 mg/kg of tranexamic acid or a similar volume of normal saline at the time of cementing of the prosthesis. Perioperative blood loss was recorded and patients were screened for DVT with duplex ultrasound assessment of both legs on the fifth post-operative day. RESULTS: A statistically significant (p=0.006) decrease in blood loss in the early post-operative period was noted in the group receiving tranexamic acid. This was not associated with a significant difference in total blood loss (p=0.55) or in transfusion requirements. There was no of evidence in DVT in either group on duplex ultrasound screening of the lower limbs. INTERPRETATION: One injection of 15 mg/kg of tranexamic given at the time of cementing the prosthesis in total knee arthroplasty, before deflation of the tourniquet, significantly decreases the amount of blood loss in the early post-operative period. The treatment was not associated with an increase in thromboembolic complications.

Outcome scoring system evaluation of knee osteoarthritis in patients awaiting TKA.

One hundred and twenty-four patients with knee osteoarthritis were reviewed at three stages over a mean of 24 months (range: 9-32 months) at the time of referral by the general practitioner, by the orthopedic consultant, and before surgery. At each visit, patients were examined and the American Knee Society score and Oxford Knee Society score were obtained. The functional element of the American Knee Score deteriorated significantly from the time of referral until the time of first orthopedic consultation (P=.005) and from the time of referral to the time of surgery (P=.006). The pain element of the American Knee Society score improved from the time of referral till the time of orthopedic assessment (P=.011). The change in Oxford Knee Society score between the time the patient was put on the waiting list to the time of surgery was not statistically significant (P=.30). This article questions the emphasis on surgical waiting times instead of symptoms and physical function in determining timing of surgery.

Delayed presentation of septic arthritis of a lumbar facet joint after diagnostic facet joint injection.

We report the case of a 46-year-old, otherwise healthy, man with chronic lower back pain and no evidence of nerve root compression who underwent diagnostic facet joint injections to assist in establishing where his pain sources were located and to try to help his spinal rehabilitation program. He presented with a facet joint infection 2 months after injection, in a manner that was indistinguishable from an acute intervertebral disc herniation. The diagnosis was confirmed on magnetic resonance imaging, and he was successfully treated with surgical debridement and antibiotics. Septic arthritis of a lumbar facet joint with an associated paraspinal abscess is a rare complication of facet joint infiltration with only two similar cases reported in the literature. We propose that this diagnosis be considered in patients who have undergone diagnostic facet joint injection who subsequently deteriorate with back and leg pain without another apparent cause.

Left-sided gastroschisis and pseudoexstrophy: a rare combination of anomalies.

Pseudoexstrophy is a rare variant of the exstrophy/epispadias complex, comprised of the musculoskeletal defects of classic exstrophy but with an intact bladder and urethra. We present a case of a neonate with left-sided gastroschisis and pseudoexstrophy, the first reported combination of these two anomalies. The anomalies in this case were unusual but highlight the importance of careful clinical evaluation before and during surgery so as to carefully define the anatomy of the abnormalities, which will assist in planning surgery and further postoperative management. Identifying and reporting these unusual cases is essential to further expand our understanding of these conditions and their potential associations.

Avascular necrosis of the femoral head after surgery for lumbar spinal stenosis.

STUDY DESIGN: Case report. OBJECTIVE: To report a previously undescribed complication of lumbar spinal surgery under prolonged hypotensive anesthesia. BACKGROUND DATA: Avascular necrosis of bone most commonly affects the femoral head. The etiology of the condition is understood in only 75% of cases. There have been no prior reports of this condition following lumbar spine surgery carried out under hypotensive anesthetic. METHODS: Notes review, clinical examination, plain radiographs, and magnetic resonance imaging diagnosed three patients who developed avascular necrosis of the femoral heads (five joints in total) after surgery for lumbar spinal stenosis. All three were treated with total hip replacement (five joints), and the diagnosis of avascular necrosis was confirmed in two by histopathological examination. RESULTS: All three patients have recovered full mobility following hip replacement surgery. None had any residual symptoms of lumbar spinal stenosis or hip disease, and none of them had shown any clinical evidence of avascular necrosis in any other bone. CONCLUSIONS: The development of avascular necrosis of the femoral heads following surgery for spinal stenosis may be due to hypotensive anesthesia, prone positioning on a Montreal mattress, or a combination of the two. Careful intraoperative positioning may reduce the risk of this occurring after spinal surgery. However, close postoperative surveillance and a high index of suspicion of worsening hip pathology in patients who appear to mobilize poorly after lumbar spinal surgery may be the only method of early detection and treatment for this condition.