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MacDowall, A., Canto Moreira, N., Marques, C., Skeppholm, M., Lindhagen, L., Robinson, Y., . . . Olerud, C. (2019). Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes. Journal of Neurosurgery: Spine, 30(3), 323-331
Open this publication in new window or tab >>Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes
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2019 (English)In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 30, no 3, p. 323-331Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE

The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, long-term follow-up evaluations using MRI are needed to investigate if this intent is achieved.

METHODS

The authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.

RESULTS

Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.

CONCLUSIONS

In patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.

Keywords
artificial disc replacement, treatment outcome, Neck Disability Index, cervical radiculopathy, adjacent-segment pathology
National Category
Orthopaedics Neurology
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-345965 (URN)10.3171/2018.9.SPINE18659 (DOI)000462447900004 ()30641852 (PubMedID)
Projects
Cervical radiculopathy, studies on pain analysis and treatment
Note

Title in thesis list of papers: Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy ‒ 5-year Outcomes

Available from: 2018-03-13 Created: 2018-03-13 Last updated: 2019-04-16Bibliographically approved
MacDowall, A., Skeppholm, M., Lindhagen, L., Robinson, Y., Löfgren, H., Michaëlsson, K. & Olerud, C. (2019). Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy: 5-year Outcomes from the National Swedish Spine Register. Journal of Neurosurgery: Spine, 30(2), 159-167
Open this publication in new window or tab >>Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy: 5-year Outcomes from the National Swedish Spine Register
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2019 (English)In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 30, no 2, p. 159-167Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: The long-term efficacy of artificial disc replacement (ADR) surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy has not previously been investigated in a population-based setting.

METHODS: All patients with cervical degenerative disc disease and radiculopathy who were in the national Swedish Spine Registry (Swespine) beginning in January 1, 2006, were eligible for the study. Follow-up information was obtained up to November 15, 2017. The authors compared, using propensity score matching, patients treated with anterior decompression and insertion of an ADR with patients who underwent anterior decompression combined with fusion surgery. The primary outcome was the Neck Disability Index (NDI), a patient-reported function score ranging from 0% to 100%, with higher scores indicating greater disability and a minimum clinically important difference of > 15%.

RESULTS: A total of 3998 patients (2018: 1980 women/men) met the inclusion criteria, of whom 204 had undergone arthroplasty and 3794 had undergone fusion. After propensity score matching, 185 patients with a mean age of 49.7 years remained in each group. Scores on the NDI were approximately halved in both groups after 5 years, but without a significant mean difference in NDI (3.0%; 95% CI -8.4 to 2.4; p = 0.28) between the groups. There were no differences between the groups in EuroQol-5 Dimensions or in pain scores for the neck and arm.

CONCLUSIONS: In patients with cervical degenerative disc disease and radiculopathy, decompression plus ADR surgery did not result in a clinically important difference in outcomes after 5 years, compared with decompression and fusion surgery.

Keywords
Cervical radiculopathy, Artificial disc replacement, Surgical treatment outcome, Anterior decompression and fusion
National Category
Orthopaedics
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-345976 (URN)10.3171/2018.7.SPINE18657 (DOI)000461013000002 ()30485205 (PubMedID)
Projects
Cervical radiculopathy, studies on pain analysis and treatment
Available from: 2018-03-13 Created: 2018-03-13 Last updated: 2019-04-16Bibliographically approved
Eriksson, T., Berg, P., Olerud, C., Shalabi, A. & Hänni, M. (2019). Low-dose CT of postoperative pelvic fractures: a comparison with radiography. Acta Radiologica (1), 85-91
Open this publication in new window or tab >>Low-dose CT of postoperative pelvic fractures: a comparison with radiography
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2019 (English)In: Acta Radiologica, ISSN 0284-1851, E-ISSN 1600-0455, no 1, p. 85-91Article in journal (Refereed) Published
Abstract [en]

Background Computed tomography (CT) is superior to conventional radiography (CR) for assessing internal fixation of pelvic fractures, but with a higher radiation exposure. Low-dose CT (LDCT) could possibly have a sufficient diagnostic accuracy but with a lower radiation dose. Purpose To compare postoperative diagnostic accuracy of LDCT and CR after open reduction and internal fixation of pelvic fracture. Material and Methods Twenty-one patients were examined with LDCT and CR 0-9 days after surgery. The examinations were reviewed by two musculoskeletal radiologists. Hardware, degree of fracture reduction, image quality, and reviewing time were assessed, and effective radiation dose was calculated. Inter-reader agreement was calculated. Results LDCT was significantly better than CR in determining whether hardware positioning was assessable ( P < 0.001). Acetabular congruence was assessable in all fractured patients with LDCT. In 12 of the 32 assessments with CR of patients with an acetabular fracture, joint congruence was not assessable due to overlapping hardware ( P = 0.001). Image quality was significantly higher for LDCT. Median time to review was 240 s for LDCT compared to 180 s for CR. Effective dose was 0.79 mSv for LDCT compared to 0.32 mSv for CR ( P < 0.001). Conclusion LDCT is more reliable than CR in assessing hardware position and fracture reduction. Joint congruency is sometimes not possible to assess with CR, due to overlapping hardware. The image quality is higher, but also the effective dose, with LDCT than with CR.

Keywords
CT, Low dose computed tomography, image quality, pelvic fracture, radiation dose, radiography
National Category
Radiology, Nuclear Medicine and Medical Imaging
Identifiers
urn:nbn:se:uu:diva-350775 (URN)10.1177/0284185118770919 (DOI)000453211800011 ()29665704 (PubMedID)
Available from: 2018-05-16 Created: 2018-05-16 Last updated: 2019-01-25Bibliographically approved
Tominaga, H., MacDowall, A. & Olerud, C. (2019). Surgical treatment of the severely damaged atlantoaxial joint with C1-C2 facet spacers Three case reports. Medicine (Baltimore, Md.), 98(22), Article ID e15827.
Open this publication in new window or tab >>Surgical treatment of the severely damaged atlantoaxial joint with C1-C2 facet spacers Three case reports
2019 (English)In: Medicine (Baltimore, Md.), ISSN 0025-7974, E-ISSN 1536-5964, Vol. 98, no 22, article id e15827Article in journal (Refereed) Published
Abstract [en]

Rationale: Atlantoaxial subluxation (AAS), caused by congenital factors, inflammation such as rheumatoid arthritis, infection, neoplasia, or trauma, is rare and severely erodes and subluxates atlantoaxial (AA) joints. For these patients, surgical reduction, and stabilization are difficult. Surgery, including anterior transoral decompression and posterior fixation, anterior endonasal decompression and fixation, and posterior decompression with AA or occipitocervical fixation, is often the only treatment available. However, there have only been 2 reports of C1-C2 facet spacer use in treating AAS. Here, we report the case histories of 3 patients with severely damaged and subluxated AA joints and symptomatic basilar invagination (BI), malalignment, or C2 root compression. Patient concerns: The cases included 2 women with rheumatoid arthritis and 1 man with spondyloarthropathy secondary to ulcerative colitis. Diagnosis: Radiographic imaging revealed severely damaged and subluxated AA joints. Their symptoms included worsening pain in the neck or occiput with or without myelopathy and neuralgia. Interventions: After realignment with C1-C2 spacers and posterior C1-C2 screw fixation, the patient symptoms were resolved. Outcomes: Of note, 2 of the 3 patients were healed without complications. One patient who underwent secondary revision surgery because of rod breakage and obvious nonunion at C0-C2 was determined to be healed at 1-year follow-up after the revision surgery. Lessons: We confirmed that C1-C2 facet spacers both reduced BI and occipitocervical coronal malalignment as well as releasing C2 root compression. Therefore, surgical restoration and fixation should be a required treatment in this very rare group of patients.

Place, publisher, year, edition, pages
LIPPINCOTT WILLIAMS & WILKINS, 2019
Keywords
basilar invagination, C1-C2 facet spacer, coronal malalignment, occipital neuralgia, severely damaged atlantoaxial joint
National Category
Orthopaedics Surgery
Identifiers
urn:nbn:se:uu:diva-393533 (URN)10.1097/MD.0000000000015827 (DOI)000480717300053 ()31145323 (PubMedID)
Available from: 2019-09-24 Created: 2019-09-24 Last updated: 2019-09-24Bibliographically approved
Manabe, N., Covaro, A., Bobinski, L., Shimizu, T., Olerud, C. & Robinson, Y. (2019). The Relationship between the Occipitocervical Junction and Thoracic Kyphosis in Ankylosing Spondylitis: A Retrospective Cohort Study of 86 Cervical Fractures in Surgically Treated Patients. Asian Spine Journal, 13(1), 103-110
Open this publication in new window or tab >>The Relationship between the Occipitocervical Junction and Thoracic Kyphosis in Ankylosing Spondylitis: A Retrospective Cohort Study of 86 Cervical Fractures in Surgically Treated Patients
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2019 (English)In: Asian Spine Journal, ISSN 1976-1902, E-ISSN 1976-7846, Vol. 13, no 1, p. 103-110Article in journal (Refereed) Published
Abstract [en]

Study Design: Retrospective analysis of prospectively collected data.

Purpose: To describe the radiological characteristics of the occipitocervical area in patients with ankylosing spondylitis (AS) using the novel measure X-angle and to describe the correlation between the ankylosed occipitoatlantoaxial (OAA) joint and thoracic kyphosis (TK).

Overview of Literature: AS affects the axial skeleton, leading to progressive ankylosis of all vertebral segments. The effect of ankylosis on the upper cervical area of these patients is not well documented.

Methods: All patients with complete ankylosis of the spinal column between C3 and T1, treated for cervical spinal fracture between 2007 and 2014, were eligible for inclusion in this study. The level of cervical fracture was identified. The T1-12 and T5-12 angles were measured using preoperative lateral radiography. The progressive degeneration of the C0-C1-C2 joints was evaluated via the new indicator X-angle, through the measurement of the angle of the C0-C1-C2 articulations in the coronal plane using computed tomography.

Results: We included 86 consecutive patients with AS (67 males) aged 69±12 years. The patients were divided into two groups according to the degenerative change in the C0-C1 joint (62 patients with a mobile joint and 24 patients with an ankylosed joint). There was no significant difference between the two groups in terms of age (p =0.094) and level of fracture (p =0.949). The most commonly affected level was C6. There was no requirement for revision due to non-union in any of the patients. There was a statistically significant difference observed in the T1-12, T5-12, and X-angles (p =0.004, 0.001, and <0.001, respectively). TK was greater in the ankylosed joint group than in the mobile joint group. The X-angle was also greater in the ankylosed joint group because of the vertical destruction of the OAA joint.

Conclusions: Thoracic hyperkyphosis resulted in degenerative changes in the C0-C1-C2 joint in patients with AS. The X-angle is a reliable method for measuring the integrity of the C0-C1-C2 joint in such patients.

Keywords
Ankylosing spondylitis, Atlanto-occipital joint, Kyphosis, Spinal fracture
National Category
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-372006 (URN)10.31616/asj.2018.0010 (DOI)000457550900014 ()30326690 (PubMedID)
Available from: 2019-01-04 Created: 2019-01-04 Last updated: 2019-03-08Bibliographically approved
MacDowall, A., Skeppholm, M., Lindhagen, L., Robinson, Y. & Olerud, C. (2018). Effects of preoperative mental distress versus surgical modality, arthroplasty, or fusion on long-term outcome in patients with cervical radiculopathy. Journal of Neurosurgery: Spine, 29(4), 371-379
Open this publication in new window or tab >>Effects of preoperative mental distress versus surgical modality, arthroplasty, or fusion on long-term outcome in patients with cervical radiculopathy
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2018 (English)In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 29, no 4, p. 371-379Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE Several efforts have been made to investigate the long-term efficacy of artificial disc replacement surgery compared with that of fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy. However, research on the impact of mental distress on surgical treatment outcome has been sparse. The aim of the authors was to investigate the potential predictive value of preoperative risk factors in determining long-term outcome. METHODS A total of 153 patients (mean age 47 years) with single-or double-level cervical degenerative disc disease and radiculopathy were randomly assigned to undergo either anterior cervical discectomy and fusion (n = 70) or artificial disc replacement (n = 83). The primary outcome was the Neck Disability Index (NDI) score, a patient-reported function score that ranges from 0% to 100%; higher scores indicate greater disability. Preoperative variables such as sex, age, smoking status, employment status, having a strenuous job, neck pain duration, arm pain duration, amount of regular exercise, Hospital Anxiety and Depression Scale (HADS) score, NDI score, whether surgery was performed on 1 or 2 levels, and allocated treatment were analyzed in multiple linear regression models with the 5-year NDI score as the outcome. RESULTS A total of 47 (31%) patients had either a HADS anxiety or HADS depression score of 10 points or higher. High values on the preoperative HADS were a negative predictor of outcome (p = 0.009). Treatment allocation had no effect on 5-year NDI scores (p = 0.32). CONCLUSIONS Preoperative mental distress measured with the HADS affects long-term outcome in surgically treated patients with cervical radiculopathy.

Place, publisher, year, edition, pages
AMER ASSOC NEUROLOGICAL SURGEONS, 2018
Keywords
artificial disc replacement, Hospital Anxiety and Depression Scale, treatment outcome, Neck Disability Index, cervical radiculopathy
National Category
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-367408 (URN)10.3171/2018.2.SPINE171378 (DOI)000446246000004 ()30004317 (PubMedID)
Funder
Stockholm County Council
Available from: 2018-12-03 Created: 2018-12-03 Last updated: 2018-12-03Bibliographically approved
Robinson, Y., Lison Almkvist, V., Fahlstedt, M., Olerud, C. & Halldin, P. (2018). Finite element analysis of long posterior transpedicular instrumentation for cervicothoracic fractures related to ankylosing spondylitis. Global Spine Journal, 8(6), 570-578
Open this publication in new window or tab >>Finite element analysis of long posterior transpedicular instrumentation for cervicothoracic fractures related to ankylosing spondylitis
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2018 (English)In: Global Spine Journal, ISSN 2192-5682, E-ISSN 2192-5690, Vol. 8, no 6, p. 570-578Article in journal (Refereed) Published
Abstract [en]

Background: Spinal fractures related to AS are often treated by long posterior stabilisation. The biomechanical rationale behind is the neutralisation of long lever arms in the ankylosed spine to avoid non-union or neurological deterioration. Despite the widespread application of long posterior instrumentation it has never been investigated in a biomechanical model. The objective of this study is to develop a finite element model for spinal fractures related to AS and to establish a biomechanical foundation for long posterior stabilisation of cervicothoracic fractures related to ankylosing spondylitis (AS).

Methods: An existing finite element-model (consisting of two separately developed models) including the cervical and thoracic spine were adapted to the conditions of AS (all discs fused, C0-C1 and C1-C2 mobile) and a fracture at the level C6-C7 was simulated. Besides a normal spine (no AS, no fracture) and the uninstrumented fractured spine four different posterior transpedicular instrumentations were tested: 1. Fracture uninstrumented, 2. Short instrumentation C6-C7, 3. Medium instrumentation C5-T1, 4. Long instrumentation C3-T3, 5. Skipped level long instrumentation C3-C6-C7-T3.

Three loads (1.5g, 3.0g, 4.5g) were applied according to a specific load curve. Kinematic data such as the gap distance in the fracture site were obtained. Furthermore the stresses in the ossified parts of the discs were evaluated.

Findings: All posterior stabilisation methods could normalise the axial stability at the fracture site as measured with gap distance. With larger accelerations than 1.5g ,  it was seen that the longer instrumentations resulted in lesser maximal gap distance than the Short instrumentation. The maximum stress at the cranial instrumentation end (C3-C4) was slightly greater if every level was instrumented, than in the skipped level model. The skipped level instrumentation achieved similar rotatory stability as the long multilevel instrumentation.

Interpretation: The FE model developed simulated a spinal fracture at C6-C7 level. Skipping instrumentation levels without giving up instrumentation length also reduces the stresses in the ossified tissue within the range of the instrumentation and does not decrease the stability in a finite element model of a cervicothoracic fracture related to AS. Considering the risks associated with every additional screw placed, the skipped level instrumentation has advantages with regard to patient safety. The effects of the degree of osteoporosis, screw placement and pre-existing kyphosis on the construct stability were not investigated in this study and should be a matter of further research. 

National Category
Orthopaedics Bio Materials
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-307366 (URN)10.1177/2192568217745068 (DOI)000457230900005 ()30202710 (PubMedID)
Available from: 2016-11-14 Created: 2016-11-14 Last updated: 2019-02-18Bibliographically approved
Hirasawa, A., Robinson, Y., Olerud, C., Wakao, N., Kamiya, M., Murotani, K. & Deie, M. (2018). Regional Differences in Diffuse Idiopathic Skeletal Hyperostosis: A Retrospective Cohort Study from Sweden and Japan. Spine, 43(24), E1474-E1478
Open this publication in new window or tab >>Regional Differences in Diffuse Idiopathic Skeletal Hyperostosis: A Retrospective Cohort Study from Sweden and Japan
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2018 (English)In: Spine, ISSN 0362-2436, E-ISSN 1528-1159, Vol. 43, no 24, p. E1474-E1478Article in journal (Refereed) Published
Abstract [en]

Study Design: We retrospectively reviewed computed tomography (CT) records of patients in Japan and Sweden, which are both aging populations. Objective. To research the influence of ethnicity and region on diffuse idiopathic skeletal hyperostosis (DISH) prevalence.

Summary of Background Data_ DISH can complicate nonsurgical treatment of spinal fractures and often requires surgical intervention. We previously reported a prevalence of DISH in Japan that was higher than that reported in other studies.

Methods: We retrospectively reviewed CT records of patients in Japan and Sweden, which have both aging populations. Patients undergoing whole body CT during trauma examinations at an acute outpatient clinic in Uppsala University Hospital in a 1-year period were eligible for inclusion. Excluded were those less than 40 and more than or equal to 90 years old, and those with previous spinal surgery. The prevalence of DISH by sex and age was determined according to radiographic criteria by Resnick. Results from Sweden were compared with the Japan data, which we previously reported.

Results: Age of the eligible subjects (265 men and 153 women) ranged from 40 to 89 years, with a mean age of 63.4 years. Among men, 86 (32.5%) were diagnosed with DISH, and the results by age (40s, 50s, 60s, 70s, and 80s) were: 6 (10.7%), 13 (22%), 35 (46.1%), 17 (34%), and 15 (62.5%) patients, respectively. Among women, 16 (10.5%) had DISH, and the results by age were as follows: 1 (2.6%), 1 (3.3%), 2 (6.7%), 6 (22.2%), and 6 (22.2%) patients, respectively. These results did not differ from those previously published for Japan (Fisher exact test, men: P = 1, 0.27, 0.12, 0.06, and 1, respectively; women: P = 0.49, 0.62, 0.5, 0.8, and 0.3, respectively).

Conclusion: The presented cohort study revealed that ethnicity and region may not be notable factors of DISH prevalence, since patients from both Japan and Sweden had similar DISH prevalence.

Level of Evidence: 3

Keywords
aging, diffuse idiopathic skeletal hyperostosis, east Asia, ethnicity, north Europe, obesity, ossification, overweight, prevalence, region, sex
National Category
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-355522 (URN)10.1097/BRS.0000000000002752 (DOI)000452187300007 ()29916957 (PubMedID)
Available from: 2019-01-04 Created: 2019-01-04 Last updated: 2019-01-22Bibliographically approved
Robinson, A.-L., Olerud, C. & Robinson, Y. (2018). Surgical treatment improves survival of elderly with axis fracture: a national population-based multi-registry cohort study. The spine journal, 18, 1853-1860
Open this publication in new window or tab >>Surgical treatment improves survival of elderly with axis fracture: a national population-based multi-registry cohort study
2018 (English)In: The spine journal, ISSN 1529-9430, E-ISSN 1878-1632, Vol. 18, p. 1853-1860Article in journal (Refereed) Published
Abstract [en]

Background Context

Fractures of the axis (C2) are the most common cervical spinal injuries in the elderly population. Several authors have reported improved survival among elderly patients with C2 fractures when treated surgically.

Purpose

We aimed to analyze whether surgery improves survival of elderly with C2 fractures.

Study Design/Setting

An observational population-based longitudinal multi-registry study was carried out.

Patient Sample

Swedish Patient Registry 1997 to 2014 and Swedish Cause of Death Registry 1997 to 2014 served as source of patient sample.

Outcome measures

Survival after C2 fracture according to non-surgical and surgical treatment was the outcome measure.

Methods

We included all patients treated for the primary diagnosis of C2 fracture (10th revision of the International Statistical Classification of Diseases and Related Health Problems or ICD-10: S12.1) at an age ≥70 years and receiving treatment at a health-care facility. Non-surgical treatment comprises cervical collar or halo-vest treatment. Surgical treatment was identified in the Swedish patient registry extract using the Swedish classification of procedural codes. Survival was determined using the Kaplan-Meier method. Comorbidity was determined using the Charlson Comorbidity Index.

Results

Of the included 3,375 elderly patients with C2 fractures (43% men, aged 83±7 years), 22% were treated surgically. Surgical treatment was assigned based on age, gender, and year of treatment. The 1-year survival of 2,618 non-surgically treated patients was 72% (n=1,856), and 81% (n=614) for the 757 surgically treated (p<.001, relative risk reduction=11%). Adjusted for age, gender, comorbidity, and year of injury, surgically treated patients had greater survival than non-surgically treated patients (hazard ratio=0.88, 95% confidence interval: 0.79–0.97). Among those above 88 years of age (95% confidence interval: 85–92), surgical treatment lost its effect on survival.

Conclusions

Despite the frailty of elderly patients, the morbidity of cervical external immobilization with a rigid collar seemingly weighs greater than surgical morbidity, even in octogenarians. For those above 88 years of age, non-surgical treatment should be primarily attempted.

Keywords
Axis fractures, odontoid fractures, surgical treatment, mortality, elderly, spinal fractures
National Category
Orthopaedics
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-333896 (URN)10.1016/j.spinee.2018.03.021 (DOI)000449830800015 ()29649609 (PubMedID)
Available from: 2017-11-18 Created: 2017-11-18 Last updated: 2018-12-21Bibliographically approved
Robinson, A.-L., Schmeiser, G., Robinson, Y. & Olerud, C. (2018). Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. Trials, 19, Article ID 452.
Open this publication in new window or tab >>Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial
2018 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 452Article in journal (Refereed) Published
Abstract [en]

Background: Displaced odontoid fractures in the elderly are treated non-surgically with a cervical collar or surgically with C1-C2 fusion. Due to the paucity of evidence, the treatment decision is often left to the discretion of the expert surgeon.

Methods: The Uppsala Study on Odontoid Fracture Treatment (USOFT) is a multicentre, open-label, randomised controlled superiority trial evaluating the clinical superiority of the surgical treatment of type-2 odontoid fractures, with a 1-year Neck Disability Index (NDI) as the primary endpoint. Fifty consecutive patients aged >= 75 years, with displaced type-2 odontoid fracture, are randomised to non-surgical or surgical treatment. Excluded are patients with an American Society of Anaesthesiologists (ASA) score >= 4, dementia nursing care or anatomical cervical anomalies. The minimal clinically important difference of the NDI is 3.5 points. A minimum of 16 patients are needed in each group to test the superiority with 80% power. By considering a 1-year mortality forecast of 29%, up to 25 participants are recruited in each group. The non-surgical group is fitted with a rigid cervical collar for 12 weeks. The surgical group is treated with a posterior C1-C2 fusion. All participants are monitored with regard to the NDI, EuroQol score (EQ-5D), socio-demographics and computed tomography (CT) at the time of injury, at 6 weeks, 3 months and 12 months. At 12 months, a dynamic radiographical investigation of upper cervical stability is performed. The secondary endpoints are: EQ-5D score, activities of daily living (ADL), bony union, upper cervical stability and mortality.

Discussion: USOFT is the first randomised controlled trial comparing non-surgical and surgical management of type-2 odontoid fractures in the elderly. Using the NDI and EQ-5D as endpoints, future value-based decisions may consider quality-adjusted life years gained. Major limitations are (1) the allocation bias of the open-label study design, (2) that only higher training levels of all core specialties of spine surgery are included in the surgical treatment arm and (3) that only one type of surgical stabilisation is investigated (posterior C1-C2 fusion), while other methods are not included in this study.

Place, publisher, year, edition, pages
BMC, 2018
Keywords
Odontoid fractures, Elderly, Osteoporosis, Spinal fractures, Surgical treatment
National Category
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-363928 (URN)10.1186/s13063-018-2690-8 (DOI)000442498800004 ()30134944 (PubMedID)
Available from: 2018-10-24 Created: 2018-10-24 Last updated: 2018-10-24Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-2111-6868

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