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.

The effects of carpentry on heterotopic ossification and mobility in cervical arthroplasty: determination by computed tomography with a minimum 2-year follow-up

2012 ◽  
Vol 16 (6) ◽  
pp. 601-609 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Ching-Lan Wu ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Neck Disability Index ◽  
Ct Scanning ◽  
Segmental Motion ◽  
Artificial Disc ◽  
Analog Scale ◽  
Cervical Arthroplasty ◽  
Neck Disability

Object Heterotopic ossification (HO) after cervical arthroplasty can limit the mobility of an artificial disc. In this study the authors used CT scanning to assess the formation of HO with the goal of investigating the correlation between the carpentry of arthroplasty, formation of HO, mobility, and clinical outcomes. Methods A retrospective review of medical records, radiological studies, and clinical evaluations was conducted for consecutive patients who underwent 1- or 2-level cervical arthroplasty with the Bryan disc. The patients underwent follow-up for more than 24 months. The formation of HO was assessed using CT scanning as the final determination. The perfectness of carpentry for each arthroplasty level was scrutinized using criteria composed of 2 parameters (postoperative shell kyphosis and inadequate endplate coverage). Levels were divided into the optimal carpentry group and the suboptimal carpentry group. Radiographic and clinical outcomes, including the visual analog scale and neck disability index, were compared between the groups. Results A total of 107 levels of Bryan discs were placed in 75 patients (mean age 46.71 ± 9.94 years) and were analyzed. There was a male predominance of 68.0% (51 men), and the mean follow-up duration was 38.56 ± 9.66 months. Heterotopic ossification was identified in 60 levels (56.1%) by CT scanning. Most cases of HO were low grade and did not correlate with the limitation in the segmental motion of the arthroplasty device. There were no significant differences in terms of age, sex, and number of arthroplasty levels between the optimal and the suboptimal carpentry groups. However, the suboptimal carpentry group had significantly more high-grade HO (≥ Grade 2) than the optimal carpentry group (13 levels [12.1%] vs 7 levels [6.5%], p = 0.027). There were also more immobile (range of motion < 3°) artificial discs in the suboptimal carpentry group than the optimal carpentry group (11 levels [10.3%] vs 4 levels [3.7%], p = 0.010). The clinical outcomes (neck and arm visual analog scale scores and Neck Disability Index) in both groups were similarly good. Conclusions Shell kyphosis and inadequate endplate coverage have adverse effects on the formation of HO and segmental mobility after cervical arthroplasty with the Bryan artificial disc. Appropriate carpentry is the more important factor in determining the maintenance of segmental motion. Although the midterm clinical outcome remained similarly good regardless of HO, the carpentry of cervical arthroplasty should not be overlooked. Further studies are needed to clarify the etiology of HO.

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.

Clinical Outcomes of Cervical Laminoplasty: Results at Two Years

Neurosurgery ◽  
2016 ◽  
Vol 80 (6) ◽  
pp. 934-941 ◽  
Author(s):  
Melissa M. Stamates ◽  
Michael X. Cui ◽  
Ben Z. Roitberg
Keyword(s):  
Ct Scan ◽  
Clinical Outcomes ◽  
Visual Analog Scale ◽  
Cervical Myelopathy ◽  
Neck Disability Index ◽  
Cervical Laminoplasty ◽  
Medium Term ◽  
Analog Scale ◽  
Sf 36

Abstract BACKGROUND: Laminoplasty is an established treatment for cervical myelopathy. Multiple variations have emerged, many advocating the use of allograft, but controversy persists. OBJECTIVE: To assess medium-term clinical outcomes in patients who underwent laminoplasty with autograft at our institution. METHODS: Thirty-two consecutive patients (19 male, 13 female, average age 66 yr) from our prospective outcome registry that underwent cervical laminoplasty between 2009 and 2013 were reviewed. Computed tomography (CT) scan was performed immediately postoperatively and at 6-mo follow-up. Parameters included patient perception of outcome, Nurick score, Neck Disability Index (NDI), visual analog scale for neck pain, and SF-36. RESULTS: On retrospective analysis, all patients felt improved at 3 mo postoperatively; at 2 yr, this rate was 91%. Improvements were seen in Nurick scores, from 3.16 ± 0.9 preoperatively to 1.94 ± 0.8 at 2 yr; NDI score from 28.7% ± 9% preoperatively to 20.8% ± 9.6% at 2 yr; visual analog scale from 2.8 ± 1.2 preoperatively to 1.7 ± 0.9 at 2 yr; and SF-36 physical component summary from 27.9 ± 10 preoperatively to 37.8 ± 11.9 at 2 yr. All values reached significance at all follow-up points (P &lt; .05) with the exception of 6-mo NDI values (P = .062). No C5 palsy, graft complications, or reclosure was observed in any patient during the follow-up period. CONCLUSION: Laminoplasty with autograft is a safe and effective method to treat cervical myelopathy, with good medium-term clinical outcome. No reclosures were observed. Bony fusion was seen in all cases on CT scan. Our study found good outcomes in the performance of open-door laminoplasty without hardware, in the treatment of cervical stenosis.

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.

scholarly journals Management of cubital tunnel syndrome by anterior trans-muscular transposition of the ulnar nerve

2019 ◽  
Vol 34 (1) ◽  
Author(s):  
Ahmed Shawky Ammar ◽  
Mohamed Ahmed El Tabl ◽  
Dalia Salah Saif
Keyword(s):  
Clinical Outcome ◽  
Ulnar Nerve ◽  
Visual Analog Scale ◽  
Electrophysiological Study ◽  
Cubital Tunnel Syndrome ◽  
Nerve Entrapment ◽  
Cubital Tunnel ◽  
Analog Scale ◽  
Tunnel Syndrome ◽  
Dash Questionnaire

Abstract Background Various surgical options are used for the treatment of ulnar nerve entrapment at the elbow. In this study, anterior trans-muscular transposition of the ulnar nerve was used for the treatment of cubital tunnel syndrome. Objectives To evaluate the surgical results of anterior trans-muscular transposition technique for the treatment of cubital tunnel syndrome with particular emphasis on clinical outcome. Methods Forty patients with cubital tunnel syndrome were operated using anterior trans-muscular transposition technique. Patients were classified into post-operative clinical outcome grades according to the Wilson & Krout criteria, and they were followed up by visual analog scale (VAS), the Disability of Arm Shoulder and Hand (DASH) questionnaire, electrophysiological study, and post-operative clinical evaluation. Results Forty patients with cubital tunnel syndrome who underwent anterior trans-muscular transposition of the ulnar nerve show a significant clinical improvement at 24 months post-surgery regarding visual analog scale (VAS), the Disability of Arm Shoulder and Hand (DASH) questionnaire, electrophysiological study, and the Wilson & Krout grading as 87.5% of the patients recorded excellent and good outcome. Conclusion Anterior transmuscular transposition of the ulnar nerve is a safe and effective treatment for ulnar nerve entrapment at the elbow.

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.

Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain

2014 ◽  
Vol 21 (3) ◽  
pp. 394-399 ◽  
Author(s):  
Leah Y. Carreon ◽  
Kelly R. Bratcher ◽  
Nandita Das ◽  
Jacob B. Nienhuis ◽  
Steven D. Glassman
Keyword(s):  
Cervical Spine ◽  
Neck Pain ◽  
Regression Model ◽  
Pain Score ◽  
Rating Scales ◽  
Neck Disability Index ◽  
Correlation Coefficients ◽  
Arm Pain ◽  
Pain Scores ◽  
Neck Disability

Object The Neck Disability Index (NDI) and numeric rating scales (0 to 10) for neck pain and arm pain are widely used cervical spine disease–specific measures. Recent studies have shown that there is a strong relationship between the SF-6D and the NDI such that using a simple linear regression allows for the estimation of an SF-6D value from the NDI alone. Due to ease of administration and scoring, the EQ-5D is increasingly being used as a measure of utility in the clinical setting. The purpose of this study is to determine if the EQ-5D values can be estimated from commonly available cervical spine disease–specific health-related quality of life measures, much like the SF-6D. Methods The EQ-5D, NDI, neck pain score, and arm pain score were prospectively collected in 3732 patients who presented to the authors' clinic with degenerative cervical spine disorders. Correlation coefficients for paired observations from multiple time points between the NDI, neck pain and arm pain scores, and EQ-5D were determined. Regression models were built to estimate the EQ-5D values from the NDI, neck pain, and arm pain scores. Results The mean age of the 3732 patients was 53.3 ± 12.2 years, and 43% were male. Correlations between the EQ-5D and the NDI, neck pain score, and arm pain score were statistically significant (p < 0.0001), with correlation coefficients of −0.77, −0.62, and −0.50, respectively. The regression equation 0.98947 + (−0.00705 × NDI) + (−0.00875 × arm pain score) + (−0.00877 × neck pain score) to predict EQ-5D had an R-square of 0.62 and a root mean square error (RMSE) of 0.146. The model using NDI alone had an R-square of 0.59 and a RMSE of 0.150. The model using the individual NDI items had an R-square of 0.46 and an RMSE of 0.172. The correlation coefficient between the observed and estimated EQ-5D scores was 0.79. There was no statistically significant difference between the actual EQ-5D score (0.603 ± 0.235) and the estimated EQ-5D score (0.603 ± 0.185) using the NDI, neck pain score, and arm pain score regression model. However, rounding off the coefficients to fewer than 5 decimal places produced less accurate results. Conclusions The regression model estimating the EQ-5D from the NDI, neck pain score, and arm pain score accounted for 60% of the variability of the EQ-5D with a relatively large RMSE. This regression model may not be sufficient to accurately or reliably estimate actual EQ-5D values.

scholarly journals Anterior cervical discectomy and fusion with polyetheretherketone cages in the management of single and double level cervical spondylotic myelopathy-our experiences of 80 cases

KYAMC Journal ◽  
2018 ◽  
Vol 9 (1) ◽  
pp. 32-34
Author(s):  
Md Anowarul Islam ◽  
Mohd Alamgir Hossain ◽  
Ahmed Asif Iqbal ◽  
Md Qumruzzaman Parvez ◽  
Md Ahsanuzzaman ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Donor Site ◽  
Fusion Rate ◽  
Anterior Cervical Discectomy ◽  
Cervical Discectomy ◽  
X Ray ◽  
Arm Pain ◽  
Operative Complications ◽  
Medical University

Background: Anterior cervical discectomy with fusion (ACDF) is challenging with respect to both patient selection and choice of surgical procedure.Objectives: The aim of this study was to evaluate the clinical outcome of anterior cervical discectomy and fusion with an artificial cage made of polyetheretherketoneMaterials & Methods: From January 2012 to January 2017, 80 consecutive patients referred to the Department of spine surgery, Bangabandhu Shekh Mujib Medical University were recruited for the study. Postoperative Clinical outcome assessed with Nurick scale for myelopathy, Odom's criteria for functional outcome and Visual Analogue Scale (VAS) for both neck and arm pain. Radiological fusion was assessed by X-ray. Operative complications were reported.Results: 36 patients were operated for one level discectomy and fusion with PEEK cages and 44 patients for two levels. There were 48 (60%) males and 32 (40%) females. The age of the patients ranged from 30-72 years, a mean ± SD 45 ± 8.34. At the 2 years clinical follow-up, there were significant post operative improvements of Nurick scale, and VAS comparative to preoperative record. According to Odom's criteria, 72/80 patients (90%) were graded excellent-good.Conclusion: Anterior cervical discectomy and fusion with polyetheretherketone (PEEK) cage is an effective treatment of cervical myelopathy having higher fusion rate and lack of donor site morbidity.KYAMC Journal Vol. 9, No.-1, April 2018, Page 32-34

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