Background and Purpose

The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs.

Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). Methods. An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. Results. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion. This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK. Cite this article: Bone Jt Open 2024;5(7):612–620

The June 2023 Spine Roundup. 360. looks at: Characteristics and comparative study of thoracolumbar spine injury and dislocation fracture due to tertiary trauma; Sublingual sufentanil for postoperative pain management after lumbar spinal fusion surgery; Minimally invasive bipolar technique for adult neuromuscular scoliosis; Predictive factors for degenerative lumbar spinal stenosis; Lumbosacral transitional vertebrae and lumbar fusion surgery at level L4/5; Does recall of preoperative scores contaminate trial outcomes? A randomized controlled trial; Vancomycin in fibrin glue for prevention of SSI; Perioperative nutritional supplementation decreases wound healing complications following elective lumbar spine surgery: a randomized controlled trial

Aims

As the population ages and the surgical complexity of lumbar spinal surgery increases, the preoperative stratification of risk becomes increasingly important. Understanding the risks is an important factor in decision-making and optimizing the preoperative condition of the patient. Our aim was to determine whether the modified five-item frailty index (mFI-5) and nutritional parameters could be used to predict postoperative complications in patients undergoing simple or complex lumbar spinal fusion.

Objectives

The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery.

Objectives

We performed a systematic review of the literature to determine the safety and efficacy of bone morphogenetic protein (BMP) compared with bone graft when used specifically for revision spinal fusion surgery secondary to pseudarthrosis.

Introduction:. Several reports showed superior fusion rates, as high as 100%, using rhBMP-2 with ALIF cages. This has led to the widespread off-label use of rhBMP-2 in several other lumbar fusion procedures. There is paucity of reports analysing the clinic-radiological outcome of using rhBMP-2 to promote bone union in cases of symptomatic pseudoarthosis following lumbar spine fusion. Methods:. 52 consecutive patients who underwent revision spinal surgery for symptomatic pseudoarthosis utilizing rhBMP-2 between 2008 and 2013 were included in the study. Demographic, and surgical data were collected from medical records. Functional outcomes were recorded using the ODI. All patients had preoperative fine-cut CT scan to confirm pseudoarthosis. Postoperative CT-scan at 6 months was routinely done to confirm fusion. Results:. Average age at time of revision surgery was 54years (range 28–73). Average follow up was 3 years 5 months (range 2–5 years). Overall fusion rate of 92.3% (48/52) was achieved. The average ODI has improved from 56% preoperatively to 49% postoperatively. We had 1 infection case, and 5 complications related to metalwork. One case with neuronal complications was recorded. No rhBMP-2 related complications. There was no record of heterotopic bone formation in the spinal canal or the neuroforamen. Conclusion:. Recombinant BMP-2 is a safe and effective adjunct to revision lumbar spinal fusion surgery to alleviate back pain symptoms from pseudoarthosis. The limitations of the study include: retrospective review, lack of matched cohort utilising iliac crest bone graft, and relatively short follow-up

Introduction

Both intra- and post-operative radiographs are traditionally obtained after instrumented lumbar spinal surgery; however the clinical advantage of routine post operative images has not been demonstrated.

Purpose of study. This RCT is to determine whether or not there is a clinical benefit from inserting a dynamic stabilising implant such as the Wallis ligament on the functional recovery of patients who have undergone lumbar decompression surgery. This Interspinous implant was developed as an anatomically conserving procedure without recourse to lumbar spinal fusion surgery. The biomechanical studies have shown that unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels. The aim of this study was to identify a patential Wallis affect. Methods. Ethicallly approved. Patients were randomized into 2 groups, decompression alone or decompression with wallis interspinous ligament stabilisation. Patients were assessed pre operatively and post operatively every 6 months by VAS pain score and Oswestry Disability Index. Summary of findings. A total of 60 patients were recriuted the study from October 2005. Equal number had been randomized into two groups. The mean age of 54 (24–85) and the average follow is 36 months (6–48). The results were significantly better in decompression plus Wallis group compared to decompression alone, showing a minimal clinical difference compared to the control group. Relationship between findings and existing knowledge: Our results deomonstrate that clincial outcomes are significantly better when a Wallis implant was used in lumbar deompression. Patients experienced less back pain. Overall significance of findings: The Wallis implant represents a successful non fusion stabilisation device in the treatment of degenerative lumbar spine disease with canal stenosis. Minimal soft tissue dissection, quick rehabilitation, low morbidity. The Wallis ligament sucessfully treats spinal stenosis by reducing pain score, preserving mobility, and function

Introduction: Spinal fusions have been shown to be useful in correcting spinal deformities resulting from degenerative disc disease. We sought to produce a prospective analysis of functional outcomes following lumbar spinal fusion surgery for degenerative spondylolisthesis or degenerative scoliosis secondary to degenerative disc disease. We present the interim results from our case cohort of 74 patients. Methods: Over a period of 3 years (2005–2007), all patients who presented to this private practice with symptoms of canal stenosis or radicular pain secondary to degenerative spondylolisthesis or degenerative scoliosis were offered decompressive laminectomy and posterior lumbar interbody fusion (PLIF) surgery with interbody cages, pedicle screw instrumentation, bone morphogenic protein (BMP) and bicalcium phosphate (BCP). Patients who presented only with low back pain and did not have radicular pain or neurogenic claudication were excluded from this study. All patients who were offered spinal fusion surgery were consecutively offered the opportunity to enrol in this functional cohort analysis. Those patients who consented were prospectively entered into this functional analysis and were asked to complete Oswestry and SF-36 function questionnaires preoperatively and post-operatively. Post-operative data has been collected in some cases up to 16 months postoperatively. Patients were also assessed post-operatively by the surgeon and given an Odom clinical assessment score. Complications were also collated. Results: 102 patients were offered surgery with 18 patients not consenting to participate in this study. Of the 84 patients who consented to participate in this study, 10 patients failed to submit both pre-operative and postoperative questionnaires, leaving 74 patients who were followed for a median 7 months (range of 1.5–16 months). There were 30 males and 44 females in the study with a median age of 73 (range 46–89). Of these 74 patients, 63 had degenerative spondylolisthesis and 11 had degenerative scoliosis. 52 patients had sufficient follow-up to assess bony fusion, of which 1 patient failed to fuse. 32 of the patients who fused reported to have improved, but 16 did not and the remainder did not submit both pre-operative and post-operative questionnaires. For the SF-36 questionnaire, the median pre-operative SF-36 score was 30 (96.6% CI 26–35) and the median post-operative SF-36 score was 48 (95.3% CI 42–56). The mean difference between the preoperative and post-operative SF-36 scores was 14 (95% CI 11–18) (p< 0.0001. The median preoperative Oswestry score was 46 (96.6% CI 42–50) and the median post-operative Oswestry score was 30 (96.6% CI 24–40) and the median post-operative Oswestry score was 30 (96.6% CI 24–40). The mean difference between the preoperative and post-operative Oswestry scores was 14 (95% CI 10–19) (p= 0.0001). 45 patients (61%) reported improvements of greater than 20 between their pre-operative and post-operative scores in either their SF-36 or Oswestry questionnaires. Of these 45 patients, 40 (89%) were also given moderate or good Odom (clinical) scores. 29 patients (39%) reported that they had not experienced improvement in their symptoms based on either their SF-36 or Oswestry questionnaires, with 12 (41%) of those 29 patients scoring poorly on their Odom scores. In all, there were 18 complications ranging from wound collections (4) and breakdowns (2) to repositioning of screws (6) and nerve root injury (2), to DVT (1) and transfusion (3). Discussion: Interim results suggest that most patients undergoing PLIF and pedicle screw surgery with decompressive laminectomy for treatment of degenerative spondylolisthesis and degenerative scoliosis report significant improvements in function which correlate fairly well with clinical assessments performed by the surgeon at pre-operative and post-operative reviews. IInterestingly, patients generally reported either significant improvements (rather than borderline improvements) or that they had not improved at all, and that those who did report significant improvements also generally scored well on their Odom assessments. These reported improvements currently seem to be independent of whether bony fusion is achieved or not, as 16 of the 29 patients who did not report improvement actually achieved fusion. This is not unexpected as the initial PLIF procedure provides initial pre-fusion in situ rigid internal fixation

Introduction Infection is a risk following surgical procedures that violate the disc. Bacteria, often from normal skin flora, can be introduced into the disc space causing inflammation with destruction of the adjacent vertebrae. The incidence of iatrogenic discitis is thought to be reduced with the use of prophylactic antibiotics. Although there is substantial evidence from animal studies that prophylactic antibiotics reduce the incidence of discitis, evidence in humans is not strong. The aim of this study was to determine if levels of cephazolin in human disc and serum reached the stated minimum inhibitory concentration (MIC > 1 mg/L) against Staphylococcus aureus following intravenous administration. Methods Thirty patients (15 female and 15 male) with a mean age 42 years, (range 21–63 years) received 1g cephazolin prior to one or two level lumbar spinal fusion surgery. Venous blood was collected prior to intravenous administration of cephazolin and again at the time of disc removal to measure its concentration in serum and disc tissue. Results The interval between cephazolin administration and tissue sampling ranged from 7 to 137 minutes. Cephazolin concentration in the serum (31.1 – 148 mg/L) was greater than in the disc (0 – 9.5 mg/L). The concentration of cephazolin peaked in the serum at 7 minutes and in the disc between 37 and 53 minutes. Over 70% of the disc samples had detectable levels of cephazolin at the time the disc was removed, although only half had cephazolin levels above 1 mg/L. Discussion For a given time period the antibiotic concentration in the disc varies between patients. Only one measurement was taken from the disc using the method described when in fact if multiple measurements were taken over time there may be an antibiotic concentration peak in the disc followed by a steady decline. Variability between peak antibiotic concentration in the disc may be attributed to patient size, weight, gender, co-morbidities (diabetes, rheumatoid arthritis) and degree of disc degeneration. However the most critical variable for all patients is timing of administration of antibiotic to achieve optimal concentration in the disc when it is at greatest risk of inadvertent inoculation

Introduction: Smoking has been associated with a poor outcome from lumbar spine fusion surgery. We present our results using an intrasegmental pedicle screw device, which seems to achieve high fusion rates in patients who smoke. Methods: Between October 1998 and July 2001, 67 patients underwent lumbar interbody fusions using an intrasegmental pedicle screw device. Pre operative Short Form 36 (SF36) scores, pain visual analogue scores (VAS) and patient demographics were recorded. Postoperative follow up was performed clinically and radiographically until fusion was judged to have occurred. Radiographic criteria for fusion were: evidence of a fusion mass at all fused levels, absence of pedicle screw loosening and no metalwork breakage. Patients who did not meet this criteria were classified as either a pseudarthrosis, or indeterminate. Patients completed a questionnaire on attendance at clinic, or by post if discharged. This included an SF36, Oswestry Disability Index (ODI), employment status, analgesic use and patient satisfaction assessment. Results: 67 patients (38 male and 29 female) were successfully followed up. The mean age was 45.2 (range 17–86). Mean follow-up was 21.7 months (range 12–43 months). 36 posterolateral fusions and 31 combined posterior lumbar interbody/posterolateral fusions were performed. 22 patients were smokers and 45 non-smokers or ex-smokers at the time of surgery. Fusion rates were similar in smokers (83%) and non-smokers (80%). There was an improvement in mean VAS in both groups (Smoker/Non Smokers: Pre VAS 8.0/8.1 Post VAS 6.5/5.8). All SF36 physical component scores improved in both groups, although the improvement was slightly greater in the non-smoking group. Patient satisfaction was also similar in the two groups (Smoker/ Non-smokers: Pain “Much better” or “A little better” 58.6%/61/6%, Satisfied with outcome 72%/69%). Conclusions: We believe that our results demonstrate that the use of an intrasegmental pedicle screw device can facilitate high fusion rates in both smokers and non-smokers