Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients

2013 ◽  
Vol 18 (3) ◽  
pp. 245-254 ◽  
Author(s):  
Bruce M. McCormack ◽  
Rafael C. Bundoc ◽  
Mario R. Ver ◽  
Jose Manuel F. Ignacio ◽  
Sigurd H. Berven ◽  
...  
Keyword(s):  
Trabecular Bone ◽  
Visual Analog Scale ◽  
Short Form ◽  
Translational Motion ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Ct Scans ◽  
Cervical Lordosis ◽  
Analog Scale ◽  
Neck Disability

Object The authors present 1-year results in 60 patients with cervical radiculopathy due to spondylosis and stenosis that was treated with a bilateral percutaneous facet implant. The implant consists of a screw and washer that distracts and immobilizes the cervical facet for root decompression and fusion. Clinical and radiological results are analyzed. Methods Between 2009 and 2011, 60 patients were treated with the DTRAX Facet System in a multicenter prospective single-arm study. All patients had symptomatic clinical radiculopathy, and conservative management had failed. The majority of patients had multilevel radiographically confirmed disease. Only patients with single-level radiculopathy confirmed by history, physical examination, and in some cases confirmatory nerve blocks were included. Patients were assessed preoperatively with Neck Disability Index, visual analog scale, quality of life questionnaire (Short Form-12 version 2), CT scans, MRI, and dynamic radiographs. Surgery was percutaneous posterior bilateral facet implants consisting of a screw and expandable washer and iliac crest bone aspirate. Patients underwent postoperative assessments at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year with validated outcome questionnaires. Alterations of segmental and overall cervical lordosis, foraminal dimensions, device retention and fusion criteria were assessed for up to 1 year with CT reconstructions and radiographs. Fusion criteria were defined as bridging trabecular bone between the facets, translational motion < 2 mm, and angular motion < 5°. Results All patients were followed to 1 year postoperatively. Ages in this cohort ranged from 40 to 75 years, with a mean of 53 years. Forty-two patients were treated at C5–6, 8 at C6–7, 7 at C4–5, and 3 at C3–4. Fifty-six had bilateral implants; 4 had unilateral implants due to intraoperative facet fracture (2 patients) and inability to access the facet (2 patients). The Neck Disability Index, Short Form-12 version 2, and visual analog scale scores were significantly improved at 2 weeks and remained significantly improved up to 1 year. At the treated level, 93% had intrafacet bridging trabecular bone on CT scans, translational motion was < 2 mm in 100% and angular movement was < 5° in 83% at the 1-year follow-up. There was no significant change in overall cervical lordosis. There was a 1.6° loss of segmental lordosis at the treated level at 1 year that was significant. Foraminal width, volume, and posterior disc height was significantly increased at 6 months and returned to baseline levels at 1 year. There was no significant decrease in foraminal width and height at adjacent levels. There were no reoperations or surgery- or device-related complications, including implant failure or retained hardware. Conclusions Results indicate that the DTRAX Facet System is safe and effective for treatment of cervical radiculopathy.

scholarly journals Patient-Reported Outcomes and Patient-Reported Satisfaction After Surgical Treatment for Cervical Radiculopathy

2018 ◽  
Vol 8 (7) ◽  
pp. 703-708 ◽  
Author(s):  
Andreas Kiilerich Andresen ◽  
Rune Tendal Paulsen ◽  
Frederik Busch ◽  
Alexander Isenberg-Jørgensen ◽  
Leah Y. Carreon ◽  
...  
Keyword(s):  
Short Form ◽  
Neck Disability Index ◽  
Visual Analogue Score ◽  
Cervical Radiculopathy ◽  
Strongly Correlated ◽  
Anterior Cervical Decompression ◽  
Sf 36 ◽  
Patient Reported ◽  
Neck Disability ◽  
Cervical Degenerative Disease

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

Bioabsorbable instrumentation for single-level cervical degenerative disc disease: a radiological and clinical outcome study

2009 ◽  
Vol 11 (5) ◽  
pp. 529-537 ◽  
Author(s):  
Andre Tomasino ◽  
Harry Gebhard ◽  
Karishma Parikh ◽  
Christian Wess ◽  
Roger Härtl
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Visual Analog Scale ◽  
Neck Disability Index ◽  
Fusion Rate ◽  
Analog Scale ◽  
Single Level ◽  
Arm Pain ◽  
Neck Disability ◽  
Metallic Plates

Object The authors present the radiological and clinical outcome data obtained in patients who underwent single-level anterior cervical discectomy and fusion (ACDF) for cervical spondylosis and/or disc herniation; bioabsorbable plates were used for instrumentation. The use of metallic plates in ACDF has gained acceptance as a stabilizing part of the procedure to increase fusion rates, but when complications occur with these devices, the overall effectiveness of the procedure is compromised. As a possible solution, bioabsorbable implants for ACDF have been developed. This study investigates the feasibility and radiological and clinical outcomes of the bioabsorbable plates for ACDF. Methods The radiological and clinical outcomes of 30 patients were investigated retrospectively. All patients presented with cervical radiculopathy or myelopathy and underwent single-level ACDF in which a bioabsorbable anterior cervical plate and an allograft bone spacer were placed at a level between C-3 and C-7. Radiological outcome was assessed based on the fusion rate, subsidence, and Cobb angle of the surgical level. Clinical outcome was determined by using a visual analog scale, the Neck Disability Index, and the Odom criteria. Results There were no intraoperative complications, and no hardware failure was observed. No signs or symptoms of adverse tissue reaction caused by the implant were seen. Two reoperations were necessary due to postoperative blood collections. The overall complication rate was 16.7%. After 6 months, radiographic fusion was seen in 92.3% of patients. Subsidence at 11.3 ± 7.2 months was 3.1 ± 5.8 mm (an 8.2% change over the immediately postoperative results), and the change in the sagittal curvature was –2.7 ± 2.7°. The visual analog scale score for neck and arm pain and Neck Disability Index improved significantly after surgery (p < 0.001). Overall at 19.5 months postoperatively, 83% of the patients had favorable outcomes based on the Odom criteria. Conclusions Absorbable instrumentation provides better stability than the absence of a plate but graft subsidence and deformity rates may be higher than those associated with metal implants. There were no device-related complications, but adverse late effects cannot be excluded. The fusion rate and outcome are comparable to the results achieved with metallic plates. The authors were satisfied with the use of bioabsorbable plates as a reasonable alternative to metal, avoiding the need for lifelong metallic implants.

scholarly journals P.229 Epidemiology and Outcomes of Neck Pain Following Surgery for Degenerative Cervical Radiculopathy

2021 ◽  
Vol 48 (s3) ◽  
pp. S86-S86
Author(s):  
MA MacLean ◽  
A Dakson ◽  
F Xavier ◽  
SD Christie ◽  
C Investigators
Keyword(s):  
Neck Pain ◽  
Short Form ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Research Network ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Arm Pain ◽  
Composite Scale ◽  
Neck Disability

Background: Many studies have demonstrated improved arm pain (AP) following surgery for degenerative cervical radiculopathy (DCR); however, axial neck pain (NP) is generally not felt to improve. The purpose of this study was to determine whether surgery for DCR improves NP. Methods: A ambispective cohort study of the Canadian Spine Outcomes Research Network (CSORN) registry for patients who received 1-level, 2-level, 3-level ADCF (anterior cervical discectomy and fusion) or cervical disc arthroplasty (CDA) for DCR. Outcomes: 12-month post-operative Visual Analogue Scale for NP (VAS-NP), Neck Disability Index (NDI), VAS for AP (VAS-AP), Short-Form Physical Health Composite Scale (SF36-PCS), and Mental Health Composite Scale (SF36-MCS). Results: We identified 603 patients with DCR. CDA patients were the youngest (ANOVA; p<0.001). Patients reported similar pre-operative AP, NP, disability, and health-related quality of life, regardless of procedure (ANOVA; all P>0.05). All procedures offered a statistically significant reduction in VAS-NP, VAS-AP, and NDI (ANOVA; all P<0.001). Mean change from baseline in NP, AP, and disability, were similar across procedures. At 12 months, mean reduction in VAS-AP, VAS-NP, and NDI exceeded minimal clinically important differences for nearly all procedures. Conclusions: Patients undergoing surgery for DCR can expect a clinically significant, approximate 50% reduction in NP, AP, and neck-related disability.

i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study

Neurosurgery ◽  
2017 ◽  
Vol 83 (3) ◽  
pp. 377-384 ◽  
Author(s):  
Paul M Arnold ◽  
Rick C Sasso ◽  
Michael E Janssen ◽  
Michael G Fehlings ◽  
Robert F Heary ◽  
...  
Keyword(s):  
Bone Graft ◽  
Visual Analog Scale ◽  
Neck Disability Index ◽  
Anterior Cervical Discectomy ◽  
Analog Scale ◽  
Cervical Discectomy ◽  
Investigational Device Exemption ◽  
I Factor ◽  
Neck Disability

Abstract BACKGROUND i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE To report 2-yr follow-up. METHODS Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement &gt;15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.

Burst Spinal Cord Stimulation

Neurosurgery ◽  
2010 ◽  
Vol 66 (5) ◽  
pp. 986-990 ◽  
Author(s):  
Dirk De Ridder ◽  
Sven Vanneste ◽  
Mark Plazier ◽  
Elsa van der Loo ◽  
Tomas Menovsky
Keyword(s):  
Spinal Cord ◽  
Neuropathic Pain ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Short Form ◽  
Burst Stimulation ◽  
Analog Scale ◽  
Tonic Stimulation ◽  
Better Than

Abstract INTRODUCTION Spinal cord stimulation is commonly used for neuropathic pain modulation. The major side effect is the onset of paresthesia. The authors describe a new stimulation design that suppresses pain as well as, or even better than, the currently used stimulation, but without creating paresthesia. METHODS A spinal cord electrode (Lamitrode) for neuropathic pain was implanted in 12 patients via laminectomy: 4 at the C2 level and 7 at the T8–T9 level for cervicobrachialgia and lumboischialgia, respectively (1 at T11 at another center). During external stimulation, the patients received the classic tonic stimulation (40 or 50 Hz) and the new burst stimulation (40-Hz burst with 5 spikes at 500 Hz per burst). RESULTS Pain scores were measured using a visual analog scale and the McGill Short Form preoperatively and during tonic and burst stimulation. Paresthesia was scored as present or not present. Burst stimulation was significantly better for pain suppression, by both the visual analog scale score and the McGill Short Form score. Paresthesia was present in 92% of patients during tonic stimulation, and in only 17% during burst stimulation. Average follow-up was 20.5 months. CONCLUSION The authors present a new method of spinal cord stimulation using bursts that suppress neuropathic pain without the mandatory paresthesia. Pain suppression seems as good as or potentially better than that achieved with the currently used stimulation. Average follow-up after nearly 2 years (20.5 months) suggests that this stimulation design is stable.

High prevalence of heterotopic ossification after cervical disc arthroplasty: outcome and intraoperative findings following explantation of 22 cervical disc prostheses

2012 ◽  
Vol 17 (2) ◽  
pp. 141-146 ◽  
Author(s):  
Christopher Brenke ◽  
Johann Scharf ◽  
Kirsten Schmieder ◽  
Martin Barth
Keyword(s):  
Neck Disability Index ◽  
Adjacent Segment Degeneration ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Analog Scale ◽  
Osteophyte Formation ◽  
High Prevalence ◽  
The Mean ◽  
Neck Disability

Object Cervical disc arthroplasty (CDA) has been increasingly used for the treatment of cervical disc herniations. However, the impact of CDA on adjacent-segment degeneration and the degree of heterotopic ossification (HO) of the treated segment remain a subject of controversy. Due to a product failure of the Galileo-type disc prosthesis, 22 of these devices were explanted. The radiological and clinical course in each case was investigated in detail with an emphasis on the incidence of HO and facet joint degeneration 18 months following the operation. Intraoperative findings regarding ossification and implant fixation were documented. Thus, the authors were able to describe the true rate of adjacent-segment degeneration and HO following CDA and the clinical relevance thereof. Methods In all 22 patients, functional radiographic imaging was performed prior to surgery, 3 and 12 months after surgery, and prior to disc prosthesis explantation. At all time points, the range of motion (ROM) in the operated and adjacent segments was determined. A motion index was calculated using the preoperative and all postoperative ROMs (preoperative ROM/postoperative ROM). Computed tomography was used preoperatively to measure the height of the index segment, extent of HO, and the degree of the progression of facet arthrosis, and was used postoperatively prior to prosthesis explantation. Patients completed clinical questionnaires that included a visual analog scale and the Neck Disability Index. Results The motion index of the index segment declined gradually from 1.4 at 3 months postoperative to 1.2 prior to explantation, while the motion index of the adjacent upper segment increased from 0.9 to 1.3. The mean ROM of the index segment was 10.4° ± 6.7°, and fusion was observed in 2 (9%) of the 22 patients. Prosthesis migration was present in 3 patients (13.6%). Severe HO (Grades 3 and 4) was present in 17.4%. Computed tomography showed a significant increase of segmental height of the index segment (1.6 ± 1.1 mm, p = 0.035), and a significant increase of left-sided lateral osteophytes (1.7 ± 2.1 mm, p = 0.009). The incidence of severe osteophyte formation (> 2 mm) occurred in 40%. Intraoperative findings reflected the results from CT, with primary lateral proliferation of osteophytes found in approximately 25% of patients. The mean visual analog scale scores were 3.8 ± 2.7 (neck) and 2.4 ± 2.5 (arms), and the mean Neck Disability Index score was 30 ± 22. No correlation was found between radiological and clinical parameters. Conclusions In this study, a higher incidence of HO after CDA could be demonstrated using CT, compared with studies using fluoroscopy only. However, patient selection and/or the operative technique might have contributed to the high prevalence of osteophyte formation. Thus, the exact indication for CDA has to be reconsidered. Because implant migration was detected, using fixation in the present CDA model appears suboptimal.

STANDARD OPEN MICRODISCECTOMY VERSUS MINIMAL ACCESS TROCAR MICRODISCECTOMY

Neurosurgery ◽  
2008 ◽  
Vol 62 (1) ◽  
pp. 174-182 ◽  
Author(s):  
Yu-Mi Ryang ◽  
Markus F. Oertel ◽  
Lothar Mayfrank ◽  
Joachim M. Gilsbach ◽  
Veit Rohde
Keyword(s):  
Blood Loss ◽  
Visual Analog Scale ◽  
Oswestry Disability Index ◽  
Operative Time ◽  
Short Form ◽  
Lumbar Disc ◽  
Complication Rates ◽  
Minimal Access ◽  
Analog Scale ◽  
Short Form 36

Abstract OBJECTIVE Minimal access surgery as a less invasive alternative to standard macro- and microsurgical approaches is becoming increasingly popular in the management of traumatic and degenerative spine diseases. However, data is lacking if minimal access spine surgery is indeed beneficial. This prospective randomized study was conducted to compare efficiency, safety, and outcome of standard open microsurgical discectomy (SOMD) for lumbar disc herniation with microsurgical discectomy using an 11.5 mm trocar system for minimal access to the spine. METHODS Sixty patients were randomized to two groups of 30 patients each. Group 1 was treated by SOMD, and Group 2 was treated by minimal access microsurgical discectomy (MAMD). Perioperative parameters and pre- and postoperative clinical findings including sensory or motor deficits and pain according to the visual analog scale, Oswestry Disability Index scores, and Short Form-36 results were assessed. All patients were followed for at least 6 months postoperatively (mean, 16 mo). RESULTS Preoperatively, no statistically significant intergroup differences could be detected proving the comparability of both groups. Postoperatively, significant improvement of neurological symptoms and pain as measured by the visual analog scale, Oswestry Disability Index, and Short Form-36 scores could be achieved in both groups. In regard to operative time, intraoperative blood loss, and complication rate, slightly better results were observed in the MAMD group. CONCLUSION SOMD and MAMD allow achievement of significant improvement of pain and neurological deficits in patients with lumbar disc herniations. Differences in operative time, blood loss, and complication rates were statistically not significant in MAMD compared with SOMD, indicating that, at least in lumbar disc surgery, minimal access trocar techniques are a viable alternative to standard spinal approaches.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Control Group ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background: Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method：Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥ 5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), achievement rate of a desirable pain state (VAS score ≤ 4), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion：The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registration: NCT03858790, clinicaltrials.gov, registered on March 1st, 2019, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03858790

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