Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

Contains fulltext : 52342.pdf ( ) (Open Access)BACKGROUND: laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. METHODS/DESIGN: Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. DISCUSSION: This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT NUMBER: ISRCTN72800446

Design of the PROCON trial: a prospective, randomized multi – center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN4168184

Line from the posterior inferior part of the vertebral body of C2 to the posterior superior part o f the vertebral body of C7 in case of a normal cervical lordotic curvature (A) and a kyphotic cervical curve (B)

<p><b>Copyright information:</b></p><p>Taken from "Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy"</p><p>http://www.biomedcentral.com/1471-2474/8/111</p><p>BMC Musculoskeletal Disorders 2007;8():111-111.</p><p>Published online 9 Nov 2007</p><p>PMCID:PMC2194678.</p><p></p

Comparing Heterotopic Ossification in Two Cervical Disc Prostheses.

STUDY DESIGN: Retrospective analysis using data from randomized clinical trials. OBJECTIVE: To compare the occurrence of heterotopic ossification (HO) between two cervical disc prostheses. Clinical outcome and range of motion (ROM) were also evaluated. SUMMARY OF BACKGROUND DATA: Cervical arthroplasty was reported to be able to maintain the segmental ROM. However, controversy exists since the difference of the occurrence of HO concerning cervical prosthesis is still huge. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy due to a herniated disc from the The Netherlands Cervical Kinematics (NECK) trial (activC; metal endplates with a polyethylene inlay and a keel for primary stability) and the PROCON trial (Bryan; metal-on-polymer with titanium coated endplates without a keel) were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. Segmental ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the neck disability index (NDI) as well as physical-component summary (PCS) and mental-component summary (MCS). RESULTS: At 2-year follow-up, the occurrence of HO was 68% in patients treated with the activC prosthesis (severe HO 55%), which was comparable with 85% (P = 0.12) in patients with the Bryan disc (severe HO 44%; P = 0.43). The HO progression was similar between groups. Clinically, the patients had comparable NDI, PCS, and MCS at 2-year follow-up, and comparable improvement of clinical outcomes. The global ROM in the Bryan group (56.4 ± 10.8°) was significantly higher than in the activC group (49.5 ± 14.0, P = 0.044) at 2-year follow-up. CONCLUSION: In comparison of two cervical disc prostheses the development of HO is independent on their architecture. Although global ROM was higher in the Bryan prosthesis group, this difference was not deemed clinically important, particularly because the clinical condition of patients with and without severe HO was comparable. LEVEL OF EVIDENCE: 2.status: publishe

Implementation of an Automated Cerebrospinal Fluid Drainage System for Early Mobilization in Neurosurgical Patients

Background: Automated cerebrospinal fluid (CSF) drainage systems allow for the mobilization of patients with an external CSF drain. The aim of this study is to describe the implementation of an automated CSF drainage system in neurosurgical patients with external CSF drains. Methods: A feasibility study was performed using an automated CSF drainage system (LiquoGuard®7, Möller Medical GmbH, Fulda, Germany) in adult neurosurgical patients treated with external lumbar or external ventricular drains between December 2017 and June 2020. Limited mobilization was allowed—patients were allowed to adjust their inclined beds, sit in chairs and walk under the supervision of a nurse or physical therapist. The primary outcome was the number of prematurely terminated drainage sessions. Results: Twenty-three patients were included. Drainage was terminated prematurely in eight (35%) patients. In three (13%) of these patients, drainage was terminated due to signs of hydrocephalus. Pressure-controlled drainage in patients with external lumbar drains (ELD) showed inaccurate pressure curves, which was solved by using volume-controlled drainage in ELD patients. Conclusion: The implementation of an automated CSF drainage system (LiquoGuard®7) for CSF drainage allows for early mobilization in a subset of patients with external CSF drains. External lumbar drains require volume-based drainage rather than differential pressure-dependent drainage

Does Heterotopic Ossification in Cervical Arthroplasty Affect Clinical Outcome?

OBJECTIVE: To investigate the occurrence and progression of heterotopic ossification (HO) in patients treated by anterior cervical discectomy with arthroplasty. It was evaluated if HO affects clinical outcome and range of motion (ROM). Risk factors of HO was studied as well. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy because of a herniated disc from the NECK and PROCON trial were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. The index ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the Neck Disability Index and the 36-Item Short Form Health Survey. RESULTS: The occurrence of HO was 60% at 1 year, and it increased to 76% at 2-year follow-up. A total of 31% of patients were scored as high-grade HO at 1-year follow-up, and this percentage increased to 50% at 2-year follow-up. Clinical outcome does not correlate to HO grade, and no risk factor for high-grade HO could be identified. The ROM at the index level was significantly higher in low-grade HO group than those patients with high-grade HO, but in 15%-38% HO grade does not correspond to ROM. CONCLUSIONS: HO occurs in three fourths of the patients at 2 years after surgery, but does not necessarily correspond to clinical outcome, nor loss or preservation of ROM. The McAfee-Mehren classification should be combined with ROM evaluation to properly study HO.status: publishe

Maintaining Range of Motion after Cervical Discectomy Does not Prevent Adjacent Segment Degeneration

BACKGROUND: Motion preservation prostheses were introduced to prevent adjacent disc degeneration (ASD) and to diminish neck disability in the postsurgical follow-up. However, it is still a controversial issue, and the relationship between range of motion (ROM) and ASD has not been studied. PURPOSE: To compare the correlation between ROM of the cervical spine and the presence of radiological ASD after anterior discectomy. Clinical outcome was also correlated to ROM and ASD. STUDY DESIGN: Retrospective cohort study. METHODS: In all, 253 patients who underwent anterior discectomy for cervical radiculopathy due to a herniated disc were analyzed for segmental and global cervical ROM and the presence of ASD both preoperatively, and 12 and 24 months postoperatively. Patients who were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty, anterior cervical discectomy with intervertebral cage, or anterior cervical discectomy without intervertebral cage for one level disc herniation were analyzed. ROM was defined by a custom-developed image analysis tool. ASD was defined by decrease in disc height and anterior osteophyte formation on X-rays. Clinical outcome was evaluated by means of the Neck Disability Index (NDI). RESULTS: Two years postoperatively, no correlation was demonstrated between ROM and ASD. The incidence of ASD was comparable in the three groups, being 34% at baseline, and 58% at 2-year follow-up. Likewise, ASD progression was comparable in the three treatment arms. No correlation was demonstrated between ROM and NDI or ASD and NDI. CONCLUSIONS: Since ROM is not correlated to ASD, and clinical outcome is not correlated to ROM either, the relevance of continued ROM at the target level seems absent.status: accepte