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Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 29 - 29
1 Feb 2018
Chiarotto A Boers M Deyo R Buchbinder R Corbin T Costa L Foster N Grotle M Koes B Kovacs F Lin C Maher C Pearson A Peul W Schoene M Turk D van Tulder M Terwee C Ostelo R
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Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe


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.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 422 - 430
15 Mar 2023
Riksaasen AS Kaur S Solberg TK Austevoll I Brox J Dolatowski FC Hellum C Kolstad F Lonne G Nygaard ØP Ingebrigtsen T

Aims

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort.

Methods

This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS.


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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 30 - 30
1 Feb 2014
Morris T Hee SW Stallard N Underwood M Patel S
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Background. We have developed a LBP (low back pain) repository with IPD (individual patient data) from therapist-delivered intervention RCT's from various institutions, nationally and internationally (19 trials, 9328 patients). We will perform IPD meta-analyses to identify and determine the most effective and cost-effective treatments for subgroups of patients. Disability due to LBP is a key outcome of interest. However, there was no common disability measurement that was used in all the RCT's. We report here our assessment as to whether different disability measures are sufficiently comparable to allow pooling across trials. Method. We used data from seven trials (n = 5015 patients) that had at least two of the following measurements: RMDQ (Roland Morris Disability Questionnaire), MVK (Modified Von Korff disability score), physical component scale of SF-12/36, Patient Specific Functional Scale, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed. These change scores were then converted from one outcome measure to another with linear regression and ridge-reroughed linear models. They were also tested for correlation and responsiveness (the ability to detect changes in condition, measured by standardised response means). Conclusion. Most of the correlations between outcome measurements were high (>0.5), but responsiveness was often significantly different. Moreover, the accuracy of the conversions was poor, e.g. >40% of predictions from the conversion of RMDQ to MVK were incorrect by more than 10 points. The lack of agreement between different outcome measures suggests that conversion between different disability measurements is not recommended


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 536 - 541
1 Mar 2021
Ferlic PW Hauser L Götzen M Lindtner RA Fischler S Krismer M

Aims

The aim of this retrospective study was to compare the correction achieved using a convex pedicle screw technique and a low implant density achieved using periapical concave-sided screws and a high implant density. We hypothesized that there would be no difference in outcome between the two techniques.

Methods

We retrospectively analyzed a series of 51 patients with a thoracic adolescent idiopathic scoliosis. There were 26 patients in the convex pedicle screw group who had screws implanted periapically (Group 2) and a control group of 25 patients with bilateral pedicle screws (Group 1). The patients’ charts were reviewed and pre- and postoperative radiographs evaluated. Postoperative patient-reported outcome measures (PROMs) were recorded.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 39 - 39
1 Jun 2012
König MA Ebrahimi FV Balamurali G Boszczyk BM
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Introduction. Iatrogenic spondylolisthesis occurs infrequently after posterior decompression. Posterior surgery is challenging due to altered anatomy and scarring. Anterior lumbar interbody fusion (ALIF) allows indirect decompression, restoration of lordosis and fusion. Material and Methods. Retrospective review of 6 patients (5 female, 1 male, mean age 64±5.8 years) with iatrogenic spondylolisthesis (5 L4/L5; 1 L4/L5) treated with stand-alone ALIF (Synfix, BMP2). Assessment of pelvic incidence, listhesis, pre- and post-operative ODI, VAS, global lumbar lordosis and segmental lordosis as outcome measurements. Results. The slippage was grade II at L4/L5 in 3 patients and grade I in 2 patients at L4/L5 and 1 patient at L5/S1. Average ODI dropped from 49±11% pre-operatively to 30±9% at 6 and to 25±6% at 12 months follow-up. VAS average dropped from 7±1 to 3±1 at 6 and 12 months follow-up. Average pelvic incidence was 54.6±8.0°. Global lordosis of 44.6±5.2° increased to 49.0±8.6°; Segmental lordosis in L4/5 was increased from 12.1±8.2° to 22.4±3.7° at 6 and 20.5±7.9° at 12 months. Cage migration due to severe osteoporosis occurred in 1 case after 5 months. Conclusion. Anterior interbody fusion offers good stabilization and restoration of lordosis in iatrogenic spondylolisthesis. In our group, ODI and VAS scores were improved. These early results encourage further investigations regarding long-term follow-ups and prospective studies in larger patient groups


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 4 | Pages 508 - 512
1 Apr 2005
Lafuente J Casey ATH Petzold A Brew S

We present data relating to the Bryan disc arthroplasty for the treatment of cervical spondylosis in 46 patients. Patients with either radiculopathy or myelopathy had a cervical discectomy followed by implantation of a cervical disc prosthesis. Patients were reviewed at six weeks, six months and one year and assessment included three outcome measures, a visual analogue scale (VAS), the short form 36 (SF-36) and the neck disability index (NDI). The results were categorised according to a modification of Odom’s criteria. Radiological evaluation, by an independent radiologist, sought evidence of movement, stability and subsidence of the prosthesis. A highly significant difference was found for all three outcome measurements, comparing the pre-operative with the post-operative values: VAS (Z = 6.42, p < 0.0001), SF-36 (mental component) (Z = −5.02, p < 0.0001), SF-36 (physical component) (Z = −5.00, p < 0.0001) and NDI (Z = 7.03, p < 0.0001). The Bryan cervical disc prosthesis seems reliable and safe in the treatment of patients with cervical spondylosis


The Bone & Joint Journal
Vol. 102-B, Issue 3 | Pages 376 - 382
1 Mar 2020
Pesenti S Lafage R Henry B Kim HJ Bolzinger M Elysée J Cunningham M Choufani E Lafage V Blanco J Jouve J Widmann R

Aims

To compare the rates of sagittal and coronal correction for all-pedicle screw instrumentation and hybrid instrumentation using sublaminar bands in the treatment of thoracic adolescent idiopathic scoliosis (AIS).

Methods

We retrospectively reviewed the medical records of 124 patients who had undergone surgery in two centres for the correction of Lenke 1 or 2 AIS. Radiological evaluation was carried out preoperatively, in the early postoperative phase, and at two-year follow-up. Parameters measured included coronal Cobb angles and thoracic kyphosis. Postoperative alignment was compared after matching the cohorts by preoperative coronal Cobb angle, thoracic kyphosis, lumbar lordosis, and pelvic incidence.


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1534 - 1541
1 Dec 2019
Lagerbäck T Möller H Gerdhem P

Aims

The purpose of this study was to investigate the risk of additional surgery in the lumbar spine and to describe long-term changes in patient-reported outcomes after surgery for lumbar disc herniation in adolescents and young adults.

Patients and Methods

We conducted a retrospective study design on prospectively collected data from a national quality register. The 4537 patients were divided into two groups: adolescents (≤ 18 years old, n = 151) and young adults (19 to 39 years old, n = 4386). The risk of additional lumbar spine surgery was surveyed for a mean of 11.4 years (6.0 to 19.3) in all 4537 patients. Long-term patient-reported outcomes were available at a mean of 7.2 years (5.0 to 10.0) in up to 2716 patients and included satisfaction, global assessment for leg and back pain, Oswestry Disability Index, visual analogue scale for leg and back pain, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary and Physical Component Summary scores. Statistical analyses were performed with Cox proportional hazard regression, chi-squared test, McNemar’s test, Welch–Satterthwaite t-test, and Wilcoxon’s signed-rank test.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 3 | Pages 352 - 355
1 Mar 2005
Wilson-MacDonald J Burt G Griffin D Glynn C

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery.

There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar.