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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 50 - 50
1 Apr 2012
Grannum S Attar F Newy M
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To establish whether incidental durotomy complicating lumbar spine surgery adversely affects long-term outcome. Data was collected prospectively. The study population comprised 200 patients. 19 patients who sustained dural tears (Group A) were compared to a control group of 181 patients with no tear (Group B). Outcomes were measured with the SF-36, Oswestry Disability Index (ODI) and visual analogue scores for back (VB) and leg (VL) pain. Scores for the 2 groups were compared pre-operatively, at 2 and 6 months post-op for all patients and at long-term follow-up (range 2-9 years) for patients in group A. In addition for patients in group A the patients satisfaction with the procedure, ongoing symptoms, employment status and analgesic intake were documented. Pre-operative scores were similar between the 2 groups apart from significantly higher vb scores (63 –A vs 46-B). Results at 2 and 6 months showed no significant differences between the 2 groups. Outcome scores for group A at long-term follow-up do not show any significant decline. Our study demonstrates that incidental dural tears complicating lumbar spine surgery do not adversely affect outcome in the long-term


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 32 - 32
1 Jun 2012
Grannum S Attar F Newy M
Full Access

Purpose. To establish whether incidental durotomy complicating lumbar spine surgery adversely affects long-term outcome. Methods. Data was collected prospectively. The study population comprised 200 patients. 19 patients who sustained dural tears (Group A) were compared to a control group of 181 patients with no tear (Group B). Outcomes were measured with the SF-36, Oswestry Disability Index (ODI) and visual analogue scores for back (VB) and leg (VL) pain. Scores for the 2 groups were compared pre-operatively, at 2 and 6 months post-op for all patients and at long-term follow-up (range 2-9 years) for patients in group A. In addition for patients in group A the patients satisfaction with the procedure, ongoing symptoms, employment status and analgesic intake were documented. Results. Pre-operative scores were similar between the 2 groups apart from significantly higher vb scores (63 –A vs 46-B). Results at 2 and 6 months showed no significant differences between the 2 groups. Outcome scores for group A at long-term follow-up do not show any significant decline. Conclusion. Our study demonstrates that incidental dural tears complicating lumbar spine surgery do not adversely affect outcome in the long-term. Ethics - none, Interest –none


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1526 - 1533
1 Dec 2019
Endler P Ekman P Berglund I Möller H Gerdhem P

Aims

Chronic low back pain due to degenerative disc disease is sometimes treated with fusion. We compared the outcome of three different fusion techniques in the Swedish Spine Register: noninstrumented posterolateral fusion (PLF), instrumented posterolateral fusion (IPLF), and interbody fusion (IBF).

Patients and Methods

A total of 2874 patients who were operated on at one or two lumbar levels were followed for a mean of 9.2 years (3.6 to 19.1) for any additional lumbar spine surgery. Patient-reported outcome data were available preoperatively (n = 2874) and at one year (n = 2274), two years (n = 1958), and a mean of 6.9 years (n = 1518) postoperatively and consisted of global assessment and visual analogue scales of leg and back pain, Oswestry Disability Index, EuroQol five-dimensional index, 36-Item Short-Form Health Survey, and satisfaction with treatment. Statistical analyses were performed with competing-risks proportional hazards regression or analysis of covariance, adjusted for baseline variables.


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1464 - 1471
1 Sep 2021
Barker TP Steele N Swamy G Cook A Rai A Crawford R Lutchman L

Aims. Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods. Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results. In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion. This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 8 | Pages 1133 - 1136
1 Nov 2001
Parsch D Gaertner V Brocai DRC Carstens C

We have investigated the effect of multisegmental spinal fusion on the long-term functional and radiological outcome in patients with scoliosis. We compared these patients both with those whose spine had not been fused, and with a control group.

We studied 68 patients with idiopathic scoliosis (34 operative and 34 non-operative) who had been followed up for a minimum of five years after treatment. They were matched for age (mean 44 years) and Cobb angle (mean 54°) at follow-up. An age- and gender-matched control group of 34 subjects was also recruited.

All participants completed a questionnaire to assess spinal function and to grade the severity of back pain using a numerical rating scale. Radiographs of the spine were taken in the patients with scoliosis and lumbar degenerative changes were recorded.

The spinal function scores for the patients with scoliosis who had had a fusion were similar to those who had not. Both scoliosis groups, however, had lower scores than the control group (p < 0.001). The frequency and severity of back pain were lower for patients with scoliosis and fusion than for those without, but higher for both scoliosis groups compared with the control group. Radiographs showed similar degenerative changes in both scoliosis groups.


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 6 | Pages 851 - 855
1 Aug 2000
Newey ML Sen PK Fraser RD

We studied 32 patients with central cord syndrome who were managed conservatively. Six were under 50 years of age (group 1), 16 between 50 and 70 years (group 2) and ten over 70 years (group 3).

At the time of discharge all patients in group 1 could walk independently and had good bladder control compared with 11 (69%) and 14 (88%) in group 2 and four (40%) and two (20%) in group 3, respectively.

At follow-up after a mean of 8.6 years (4 to 15), ten patients had died leaving 22 in the study. All those in group 1 were alive, could walk independently and had bladder control. In group 2, 13 were alive of whom ten (77%) could walk independently and nine (69%) had bladder control. In group 3 only three were alive of whom only one was independent and none had bladder control.

Function at discharge as measured by the ASIA motor scoring system was usually maintained or improved at follow-up, but patients over 70 years of age at injury did poorly.


The Bone & Joint Journal
Vol. 96-B, Issue 9 | Pages 1244 - 1251
1 Sep 2014
Khoshbin A Vivas L Law PW Stephens D Davis AM Howard A Jarvis JG Wright JG

The purpose of this study was to evaluate the long-term outcome of adults with spina bifida cystica (SBC) who had been treated either operatively or non-operatively for scoliosis during childhood.

We reviewed 45 patients with a SBC scoliosis (Cobb angle ≥ 50º) who had been treated at one of two children’s hospitals between 1991 and 2007. Of these, 34 (75.6%) had been treated operatively and 11 (24.4%) non-operatively. After a mean follow-up of 14.1 years (standard deviation (sd) 4.3) clinical, radiological and health-related quality of life (HRQOL) outcomes were evaluated using the Spina Bifida Spine Questionnaire (SBSQ) and the 36-Item Short Form Health Survey (SF-36).

Although patients in the two groups were demographically similar, those who had undergone surgery had a larger mean Cobb angle (88.0º (sd 20.5; 50.0 to 122.0); versus 65.7º (sd 22.0; 51.0 to 115.0); p < 0.01) and a larger mean clavicle–rib intersection difference (12.3 mm; (sd 8.5; 1 to 37); versus 4.1 mm, (sd 5.9; 0 to 16); p = 0.01) than those treated non-operatively. Both groups were statistically similar at follow-up with respect to walking capacity, neurological motor level, sitting balance and health-related quality of life (HRQOL) outcomes.

Spinal fusion in SBC scoliosis corrects coronal deformity and stops progression of the curve but has no clear effect on HRQOL.

Cite this article: Bone Joint J 2014; 96-B:1244–51


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 7 - 7
1 Oct 2022
Evans D Rushton A Bishop J Middlebrook N Barbero M Patel J Falla D
Full Access

Background. Serious traumatic injury is a leading cause of death and disability globally, with the majority of survivors developing chronic pain. Methods. The aims of this study were to describe early predictors of poor long-term outcome for post-trauma pain. We conducted a prospective observational study, recruiting patients admitted to a Major Trauma Centre hospital in England within 14 days of their injuries, and followed them for 12 months. We defined a poor outcome as Chronic Pain Grade ≥ II and measured this at both 6-months and 12-months. A broad range of candidate predictors were used, including surrogates for pain mechanisms, quantitative sensory testing, and psychosocial factors. Univariate models were used to identify the strongest predictors of poor outcome, which were entered into multivariate models. Results. 124 eligible participants were recruited. At 6-months, 19 (23.2%) of 82 respondents reported a good outcome, whereas at 12-months 27 (61.4%) of 44 respondents reported a good outcome. The multivariate model for 6-months produced odds ratios for a unit increase in: number of fractures, 3.179 (0.52 to 19.61); average pain intensity, 1.611 (0.96 to 2.7); pain extent, 1.138 (0.92 to 1.41) and post-traumatic stress symptoms, 1.044 (0.10 to 1.10). At 12-months, equivalent values were: number of fractures, 1.653 (0.77 to 3.55); average pain intensity, 0.967 (0.67 to 1.40); pain extent, 1.062 (0.92 to 1.23) and post-traumatic stress symptoms, 1.025 (0.99 to 1.07). Conclusion. A poor long-term pain outcome from musculoskeletal traumatic injuries can be predicted by measures recorded within days of injury. Conflicts of interest: No conflicts of interest. Sources of funding: This study was funded by the National Institute for Health Research (NIHR) Surgical Reconstruction and Microbiology Research Centre (SRMRC)


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 920 - 927
1 Aug 2023
Stanley AL Jones TJ Dasic D Kakarla S Kolli S Shanbhag S McCarthy MJH

Aims. Traumatic central cord syndrome (CCS) typically follows a hyperextension injury and results in motor impairment affecting the upper limbs more than the lower, with occasional sensory impairment and urinary retention. Current evidence on mortality and long-term outcomes is limited. The primary aim of this study was to assess the five-year mortality of CCS, and to determine any difference in mortality between management groups or age. Methods. Patients aged ≥ 18 years with a traumatic CCS between January 2012 and December 2017 in Wales were identified. Patient demographics and data about injury, management, and outcome were collected. Statistical analysis was performed to assess mortality and between-group differences. Results. A total of 65 patients were identified (66.2% male (n = 43), mean age 63.9 years (SD 15.9)). At a minimum of five years’ follow-up, 32.3% of CCS patients (n = 21) had died, of whom six (9.2%) had died within 31 days of their injury. Overall, 69.2% of patients (n = 45) had been managed conservatively. There was no significant difference in age between conservatively and surgically managed patients (p = 0.062). Kaplan-Meier analysis revealed no significant difference in mortality between patients managed conservatively and those managed surgically (p = 0.819). However, there was a significant difference in mortality between the different age groups (< 50 years vs 50 to 70 years vs > 70 years; p = 0.001). At five years’ follow-up, 55.6% of the patient group aged > 70 years at time of injury had died (n = 15). Respiratory failure was the most common cause of death (n = 9; 42.9%). Conclusion. Almost one-third of patients with a traumatic CCS in Wales had died within five years of their injury. The type of management did not significantly affect mortality but their age at the time of injury did. Further work to assess the long-term functional outcomes of surviving patients is needed to generate more reliable prognostic information. Cite this article: Bone Joint J 2023;105-B(8):920–927


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 38 - 38
1 Sep 2019
Sikkens D Broekema A Soer R Reneman M Groen R Kuijlen J
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Introduction. Degeneration of the cervical spine can lead to neurological symptoms that require surgical intervention. Often, an anterior cervical discectomy (ACD) with fusion is performed with interposition of a cage. However, a cage substantially increases health care costs. The polymer polymethylmethacrylate (PMMA) is an alternative to cages, associated with lower costs. The reported high-occurrence of non-fusion with PMMA is often seen as a drawback, but evidence for a correlation between radiological fusion and clinical outcome is absent. To investigate if the lower rate of fusion with PMMA has negative effects on long-term clinical outcome, we assessed the clinical results of ACD with PMMA as a intervertebral spacer with a 5–10 year follow-up. Methods. A retrospective cohort study among all patients who underwent a mono-level ACD with PMMA for degenerative cervical disease, between 2007–2012, was performed. Patients filled out an online questionnaire, developed to assess clinical long-term outcome, complications and re-operation rates. The primary outcome measure was the Neck Disability Index (NDI), secondary outcome measures were re-operation and complication rates. Results. Of 196 eligible patients, 90 patients were assessed (response rate 53%). The average NDI score at follow-up (mean 7.5 years) was 19.0 points ± 18.0 points. Complications occurred in 10% and re-operation in 8.8%. Conclusion. This study provides evidence of good long-term clinical results of ACD with PMMA, as the results were similar with long-term outcomes of ACD with a cage as spacer. Therefore, the results of this study may suggest that the use of PMMA is an lower-cost alternative. No conflicts of interests. No funding obtained


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 27 - 27
1 May 2017
Fekete T Haschtmann D Becker H Kleinstück F Porchet F Jeszenszky D Banczerowski P Mannion A
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Background. Patient-rated measures are the gold standard for assessing spine surgery outcomes, but there is no consensus on the appropriate timing of follow-up. Journals often demand a minimum 2-year follow-up, but the indiscriminate application of this principle may not be warranted. We examined the course of change in patient outcomes up to 5 years postoperatively. Methods. The data from 3′334 consecutive patients (1′789 women, 1′545 men; aged 61±15 years) undergoing first-time surgery between 1.1.2005 and 31.12.2010 for differing lumbar degenerative disorders were evaluated. The Core Outcome Measures Index (COMI) was completed by 3′124 (94%) patients preoperatively, 3′164 (95%) at 3 months follow-up, 3′153 (95%) at 1 year, 3′112 (93%) at 2 years, and 2′897 (87%) at 5 years. 2′502 (75%) completed COMI at all five timepoints. Results. The COMI change-score from pre-op to 3 months follow-up correlated significantly with that from pre-op to 12 months (r=0.65;p<0.0001), 24 months (r=0.57;p<0.0001), and 5 years (r=0.51;p<0.0001). COMI decreased significantly from pre-op to 3 months (3.7-points), and from 3 months to 12 months (0.4-points), then levelled off up to 5 years (0.04–0.05 point-change). The course of change up to 12 months differed slightly depending on pathology/whether fusion was done. Conclusion. Stable COMI scores were seen from 1-year postoperatively onwards. As the early post-operative results appear to herald the long-term outcome, a ‘wait and see policy’ in patients with a poor initial outcome is not advocated. The insistence on a 2-year follow-up could result in a failure to intervene early to achieve better long-term outcomes. No conflicts of interest. No funding obtained


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 166 - 171
1 Feb 2023
Ragborg LC Dragsted C Ohrt-Nissen S Andersen T Gehrchen M Dahl B

Aims

Only a few studies have investigated the long-term health-related quality of life (HRQoL) in patients with an idiopathic scoliosis. The aim of this study was to investigate the overall HRQoL and employment status of patients with an idiopathic scoliosis 40 years after diagnosis, to compare it with that of the normal population, and to identify possible predictors for a better long-term HRQoL.

Methods

We reviewed the full medical records and radiological reports of patients referred to our hospital with a scoliosis of childhood between April 1972 and April 1982. Of 129 eligible patients with a juvenile or adolescent idiopathic scoliosis, 91 took part in the study (71%). They were evaluated with full-spine radiographs and HRQoL questionnaires and compared with normative data. We compared the HRQoL between observation (n = 27), bracing (n = 46), and surgical treatment (n = 18), and between thoracic and thoracolumbar/lumbar (TL/L) curves.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 315 - 322
1 Mar 2023
Geere JH Swamy GN Hunter PR Geere JL Lutchman LN Cook AJ Rai AS

Aims

To identify the incidence and risk factors for five-year same-site recurrent disc herniation (sRDH) after primary single-level lumbar discectomy. Secondary outcome was the incidence and risk factors for five-year sRDH reoperation.

Methods

A retrospective study was conducted using prospectively collected data and patient-reported outcome measures, including the Oswestry Disability Index (ODI), between 2008 and 2019. Postoperative sRDH was identified from clinical notes and the centre’s MRI database, with all imaging providers in the region checked for missing events. The Kaplan-Meier method was used to calculate five-year sRDH incidence. Cox proportional hazards model was used to identify independent variables predictive of sRDH, with any variable not significant at the p < 0.1 level removed. Hazard ratios (HRs) were calculated with 95% confidence intervals (CIs).


Bone & Joint Open
Vol. 5, Issue 10 | Pages 886 - 893
15 Oct 2024
Zhang C Li Y Wang G Sun J

Aims

A variety of surgical methods and strategies have been demonstrated for Andersson lesion (AL) therapy. In 2011, we proposed and identified the feasibility of stabilizing the spine without curettaging the vertebral or discovertebral lesion to cure non-kyphotic AL. Additionally, due to the excellent reunion ability of ankylosing spondylitis, we further came up with minimally invasive spinal surgery (MIS) to avoid the need for both bone graft and lesion curettage in AL surgery. However, there is a paucity of research into the comparison between open spinal fusion (OSF) and early MIS in the treatment of AL. The purpose of this study was to investigate and compare the clinical outcomes and radiological evaluation of our early MIS approach and OSF for AL.

Methods

A total of 39 patients diagnosed with AL who underwent surgery from January 2004 to December 2022 were retrospectively screened for eligibility. Patients with AL were divided into an MIS group and an OSF group. The primary outcomes were union of the lesion on radiograph and CT, as well as the visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores immediately after surgery, and at the follow-up (mean 29 months (standard error (SE) 9)). The secondary outcomes were total blood loss during surgery, operating time, and improvement in the radiological parameters: global and local kyphosis, sagittal vertical axis, sagittal alignment, and chin-brow vertical angle immediately after surgery and at the follow-up.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 809 - 817
27 Sep 2024
Altorfer FCS Kelly MJ Avrumova F Burkhard MD Sneag DB Chazen JL Tan ET Lebl DR

Aims

To report the development of the technique for minimally invasive lumbar decompression using robotic-assisted navigation.

Methods

Robotic planning software was used to map out bone removal for a laminar decompression after registration of CT scan images of one cadaveric specimen. A specialized acorn-shaped bone removal robotic drill was used to complete a robotic lumbar laminectomy. Post-procedure advanced imaging was obtained to compare actual bony decompression to the surgical plan. After confirming accuracy of the technique, a minimally invasive robotic-assisted laminectomy was performed on one 72-year-old female patient with lumbar spinal stenosis. Postoperative advanced imaging was obtained to confirm the decompression.


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 1007 - 1012
1 Sep 2023
Hoeritzauer I Paterson M Jamjoom AAB Srikandarajah N Soleiman H Poon MTC Copley PC Graves C MacKay S Duong C Leung AHC Eames N Statham PFX Darwish S Sell PJ Thorpe P Shekhar H Roy H Woodfield J

Aims

Patients with cauda equina syndrome (CES) require emergency imaging and surgical decompression. The severity and type of symptoms may influence the timing of imaging and surgery, and help predict the patient’s prognosis. Categories of CES attempt to group patients for management and prognostication purposes. We aimed in this study to assess the inter-rater reliability of dividing patients with CES into categories to assess whether they can be reliably applied in clinical practice and in research.

Methods

A literature review was undertaken to identify published descriptions of categories of CES. A total of 100 real anonymized clinical vignettes of patients diagnosed with CES from the Understanding Cauda Equina Syndrome (UCES) study were reviewed by consultant spinal surgeons, neurosurgical registrars, and medical students. All were provided with published category definitions and asked to decide whether each patient had ‘suspected CES’; ‘early CES’; ‘incomplete CES’; or ‘CES with urinary retention’. Inter-rater agreement was assessed for all categories, for all raters, and for each group of raters using Fleiss’s kappa.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 768 - 775
18 Sep 2024
Chen K Dong X Lu Y Zhang J Liu X Jia L Guo Y Chen X

Aims

Surgical approaches to cervical ossification of the posterior longitudinal ligament (OPLL) remain controversial. The purpose of the present study was to analyze and compare the long-term neurological recovery following anterior decompression with fusion (ADF) and posterior laminectomy and fusion with bone graft and internal fixation (PLF) based on > ten-year follow-up outcomes in a single centre.

Methods

Included in this retrospective cohort study were 48 patients (12 females; mean age 55.79 years (SD 8.94)) who were diagnosed with cervical OPLL, received treatment in our centre, and were followed up for 10.22 to 15.25 years. Of them, 24 patients (six females; mean age 52.88 years (SD 8.79)) received ADF, and the other 24 patients (five females; mean age 56.25 years (SD 9.44)) received PLF. Clinical data including age, sex, and the OPLL canal-occupying ratio were analyzed and compared. The primary outcome was Japanese Orthopaedic Association (JOA) score, and the secondary outcome was visual analogue scale neck pain.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


Aims

The optimal procedure for the treatment of ossification of the posterior longitudinal ligament (OPLL) remains controversial. The aim of this study was to compare the outcome of anterior cervical ossified posterior longitudinal ligament en bloc resection (ACOE) with posterior laminectomy and fusion with bone graft and internal fixation (PTLF) for the surgical management of patients with this condition.

Methods

Between July 2017 and July 2019, 40 patients with cervical OPLL were equally randomized to undergo surgery with an ACOE or a PTLF. The clinical and radiological results were compared between the two groups.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 679 - 687
1 Jun 2023
Lou Y Zhao C Cao H Yan B Chen D Jia Q Li L Xiao J

Aims

The aim of this study was to report the long-term prognosis of patients with multiple Langerhans cell histiocytosis (LCH) involving the spine, and to analyze the risk factors for progression-free survival (PFS).

Methods

We included 28 patients with multiple LCH involving the spine treated between January 2009 and August 2021. Kaplan-Meier methods were applied to estimate overall survival (OS) and PFS. Univariate Cox regression analysis was used to identify variables associated with PFS.