Use of zero-profile device for contiguous three-level anterior cervical discectomy and fusion: comparison with cage and plate construct

2021 ◽  
pp. 1-8
Author(s):  
Zhipeng Chen ◽  
Shuizhong Cen ◽  
Jionglin Wu ◽  
Rui Guo ◽  
Zhenhua Liu ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Sagittal Alignment ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Patient Choice ◽  
Adjacent Segment ◽  
Radiographic Findings ◽  
Significant Difference ◽  
Patient Reported

OBJECTIVE The aim of this study was to compare a traditional cervical cage with a zero-profile (ZP) fixation device in patients who underwent three-level anterior cervical decompression and fusion (ACDF) in terms of patient-reported outcomes (visual analog scale [VAS], Japanese Orthopaedic Association [JOA], and Neck Disability Index [NDI] scores), radiographic findings (sagittal alignment 2 years after surgery and likelihood of fusion), and complications. METHODS This study was a retrospective case series. Between January 2012 and December 2016, 58 patients with cervical spondylotic myelopathy (CSM) who required three-level ACDF procedures, as identified by spinal surgeons, were treated with three-level ACDF and an anterior cage-plate construct (ACPC) (n = 38) or a three-level stand-alone ZP device (n = 20). On the basis of patient choice, patients were divided into two groups (ACPC group and ZP group). All patients completed a minimum of 2 years of follow-up. Patient-reported outcome scores included VAS, JOA, and NDI scores. The radiographic findings included sagittal alignment and likelihood of fusion 2 years after surgery. Data related to patient-reported outcomes and sagittal alignment were collected preoperatively, postoperatively, and at the final follow-up. Intraoperative and postoperative complications were also documented and analyzed. RESULTS The clinical outcomes, including VAS, JOA, and NDI scores, showed improvement in both groups, and no significant difference was observed between the two groups. Sagittal alignment and height of the fused segments were restored in all patients. However, the authors found no differences between the ZP and ACPC groups, and the groups exhibited similar fusion rates. The authors found no differences in complications, including dysphagia, adjacent-segment degeneration, and postoperative hematoma, between the groups. CONCLUSIONS Use of ZP implants yielded satisfactory long-term clinical and radiological outcomes that were similar to those of the standard ACPC. Additionally, the rates of complications between the groups were not significantly different. Although the best surgical option for multilevel CSM remains controversial, the results of this work suggest that ACDF with the ZP device is feasible, safe, and effective, even for multilevel CSM.

P76 Skip laminectomy versus cervical laminectomy, an analysis of patient reported outcomes, spinal alignment and re-operation rates: the leeds spinal unit experience (2008–2016)

2019 ◽  
Vol 90 (3) ◽  
pp. e42.1-e42
Author(s):  
JMW Robins ◽  
L Luo ◽  
F Mallallah ◽  
J Timothy ◽  
D Pal ◽  
...  
Keyword(s):  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Patient Reported Outcomes ◽  
Sagittal Alignment ◽  
Neck Disability Index ◽  
Cervical Laminectomy ◽  
Patient Reported ◽  
Neck Disability ◽  
Skip Laminectomy

ObjectivesTo compare clinical, radiological and complication results between skip laminectomy and cervical laminectomy for posterior cervical decompression for cervical spondylotic myelopathy.DesignRetrospective single institution cohort study.SubjectsSubjects underwent primary skip or cervical laminectomy between 2008–2016.MethodsStatistical analysis compared pre- and post-operative differences in Visual Analogue Scale, Neck Disability Index and radiological differences in sagittal alignment of the vertebral bodies. Analysis of re-operation rates was performed.ResultsA total of 42 and 29 patients had skip and cervical laminectomy respectively. Median follow up was 32±23.1 (Range: 1–325) weeks. Post-operatively there was no difference in patient reported outcomes namely Visual Analogue Scale and Neck Disability Index between skip laminectomy and cervical laminectomy groups compared to pre-operatively (p=0.64, p=0.75). No difference was seen in sagittal alignment between both groups following surgery (p=0.65). Three patients (7.1%) in the skip laminectomy group and two patients (6.9%) in the cervical laminectomy group required revision surgery to the cervical spinal region at a different level to the original surgery. No patients needed further instrumentation.ConclusionsBoth skip laminectomy and cervical laminectomy appear to deliver similar outcomes with regards to patient reported outcomes, preserving sagittal alignment and re-operation rates over this short follow-up period.

No Difference in Outcomes Following Osteochondral Allograft with Fresh Precut Cores Compared to Hemi-Condylar Allografts

Cartilage ◽  
2021 ◽  
pp. 194760352110219
Author(s):  
Danielle H. Markus ◽  
Anna M. Blaeser ◽  
Eoghan T. Hurley ◽  
Brian J. Mannino ◽  
Kirk A. Campbell ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Knee Injury ◽  
Lesion Size ◽  
Osteochondral Allograft ◽  
Osteochondral Lesions ◽  
Radiographic Outcomes ◽  
Significant Difference ◽  
Patient Reported ◽  
The Mean

Objective The purpose of the current study is to evaluate the clinical and radiographic outcomes at early to midterm follow-up between fresh precut cores versus hemi-condylar osteochondral allograft (OCAs) in the treatment of symptomatic osteochondral lesions. Design A retrospective review of patients who underwent an OCA was performed. Patient matching between those with OCA harvested from an allograft condyle/patella or a fresh precut allograft core was performed to generate 2 comparable groups. The cartilage at the graft site was assessed with use of a modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system and patient-reported outcomes were collected. Results Overall, 52 total patients who underwent OCA with either fresh precut OCA cores ( n = 26) and hemi-condylar OCA ( n = 26) were pair matched at a mean follow-up of 34.0 months (range 12 months to 99 months). The mean ages were 31.5 ± 10.7 for fresh precut cores and 30.9 ± 9.8 for hemi-condylar ( P = 0.673). Males accounted for 36.4% of the overall cohort, and the mean lesion size for fresh precut OCA core was 19.6 mm2 compared to 21.2 mm2 for whole condyle ( P = 0.178). There was no significant difference in patient-reported outcomes including Visual Analogue Scale, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, and Tegner ( P > 0.5 for each), or in MOCART score (69.2 vs. 68.3, P = 0.93). Conclusions This study found that there was no difference in patient-reported clinical outcomes or MOCART scores following OCA implantation using fresh precut OCA cores or size matched condylar grafts at early to midterm follow-up.

Radiographic Outcomes of Mobile-Bearing Total Ankle Arthroplasty for Patients With Rheumatoid Arthritis

2019 ◽  
Vol 40 (9) ◽  
pp. 1037-1042
Author(s):  
Koichiro Yano ◽  
Katsunori Ikari ◽  
Ken Okazaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Tibial Component ◽  
Patient Reported Outcomes ◽  
Mobile Bearing ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthroplasty ◽  
Radiographic Outcomes ◽  
Significant Difference ◽  
Patient Reported

Background: Ankle disorders in patients with rheumatoid arthritis (RA) reduce their quality of life and activities of daily living. The aim of this study was to evaluate the midterm clinical and radiographic outcomes of TAA in patients with RA. Methods: This retrospective study included patients with a minimum follow-up of 2 years. A total of 37 RA patients (39 ankles) were enrolled in this study from August 2006 to March 2016. All the patients had undergone primary cemented mobile-bearing total ankle arthroplasty (TAA). Nine ankles received arthrodesis of the subtalar joint simultaneously. Patient-reported outcomes were measured preoperatively and at the latest follow-up by Self-Administered Foot-Evaluation Questionnaire (SAFE-Q). Radiographs of the ankle were analyzed preoperatively and at all follow-up visits to measure the periprosthetic radiolucent line, migration of the tibial component, and the subsidence of the talar component. Intraoperative and postoperative complications were recorded. The average duration of follow-up for the entire cohort was 5.0 ± 2.0 years (range 2.1-10.1 years). Results: All subscales of the SAFE-Q had improved significantly at the latest follow-up. No significant difference was found between the range of motion of the ankle before and after the surgery. Radiolucent lines were observed in 28 (73.7%) ankles. Migration of the tibial component and subsidence of the talar component were found in 8 (21.1%) and 11 (28.9%) ankles, respectively. Intraoperative malleolus fractures occurred in 3 (7.7%) ankles and delayed wound healing in 10 (25.6%) ankles. Four ankles were removed because of deep infection or noninfective loosening, resulting in an implant survival rate of 88.4% (95% CI, 0.76-1.0) at 10 years. Conclusion: The midterm patient-reported outcomes and implant retention rate after cemented mobile-bearing TAA for RA patients were satisfactory. However, a low radiographic implant success rate was observed. Level of Evidence: Level IV, retrospective case series.

Does Obesity Correlate With Worse Patient-Reported Outcomes Following Elective Anterior Cervical Discectomy and Fusion?

Neurosurgery ◽  
2016 ◽  
Vol 79 (1) ◽  
pp. 69-74 ◽  
Author(s):  
John A. Sielatycki ◽  
Chotai Silky ◽  
Kay Harrison ◽  
David Stonko ◽  
Matthew McGirt ◽  
...  
Keyword(s):  
Scale Score ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Japanese Orthopaedic Association Score ◽  
Association Score ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Neck Disability

Abstract BACKGROUND Studies have investigated the impact of obesity in thoracolumbar surgery; however, the effect of obesity on patient-reported outcomes (PROs) following anterior cervical discectomy and fusion (ACDF) is unknown. OBJECTIVE To examine the relationship between obesity and PROs following elective ACDF. METHODS Consecutive patients undergoing ACDF for degenerative conditions were evaluated. Patients were divided into groups with a body mass index ≥35. The EuroQol-5D, Short-Form 12 (SF-12), modified Japanese Orthopaedic Association score, and Neck Disability Index were used. Correlations between PROs and obesity were calculated at baseline and 1 year. RESULTS A total of 299 patients were included, with 80 obese (27%) and 219 nonobese (73%). patients At baseline, obesity was associated with worse myelopathy (modified Japanese Orthopaedic Association score: 10.7 vs 12.2, P = .01), general physical health (SF-12 physical component scale score: 28.7 vs 31.8, P = .02), and general mental health (SF-12 mental component scale score: 38.9 vs 42.3, P = .04). All PROs improved significantly following surgery in both groups. There was no difference in absolute scores and change scores for any PRO at 12 months following surgery. Furthermore, there was no difference in the percentage of patients achieving a minimal clinically important difference for the Neck Disability Index (52% vs 56%, P = .51) and no difference in patient satisfaction (85% vs 85%, P = .85) between groups. CONCLUSION Obesity was not associated with less improvement in PROs following ACDF. There was no difference in the proportion of patients satisfied with surgery and those achieving a minimal clinically important difference across all PROs. Obese patients may therefore achieve meaningful improvement following elective ACDF.

scholarly journals Surgical and Functional Outcomes of Expansive Open-Door Laminoplasty for Patients With Mild Kyphotic Cervical Alignment

Neurospine ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. 749-757
Author(s):  
Narihito Nagoshi ◽  
Satoshi Nori ◽  
Osahiko Tsuji ◽  
Satoshi Suzuki ◽  
Eijiro Okada ◽  
...  
Keyword(s):  
Functional Outcomes ◽  
Patient Reported Outcomes ◽  
Japanese Orthopaedic Association ◽  
Clinical Information ◽  
Compensatory Mechanism ◽  
Open Door ◽  
Single Center Study ◽  
Patient Reported

Objective: To evaluate the cervical dynamics, neurological function, pain, and quality of life in patients with mild cervical kyphotic alignment who underwent expansive unilateral open-door laminoplasty (ELAP).Methods: In this retrospective single-center study, we reviewed the surgical outcomes of 80 patients with cervical spondylotic myelopathy who were followed for at least 2 years. The patients were categorized into the preoperative kyphotic group (C2–7 angle < 0°) and nonkyphotic group (angle ≥ 0°). We compared clinical information, radiographic parameters, Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) scores, and cervical Japanese Orthopaedic Association (JOA) scores between the groups.Results: The kyphotic and nonkyphotic groups comprised 17 and 63 patients, respectively. The preoperative C2–7 angles were -3.7° in the kyphotic group and 15.4° in the nonkyphotic group (p < 0.01). In the kyphotic group, kyphotic alignment improved to lordosis at the final follow-up (2.6°, p = 0.01). The preoperative (16.4° vs. 24.1°, p < 0.01) and finalfollow-up (17.8° vs. 24.5°, p < 0.01) C7 slopes were significantly smaller in the kyphotic group. ELAP reduced pain in the arms or hands (p = 0.02) and improved the JOA scores (p < 0.01) in the kyphotic group. Patient-reported outcomes assessed using the JOACMEQ showed comparable effective rates in both groups.Conclusion: Patients with mild cervical kyphosis showed smaller C7 slopes as a compensatory mechanism. Kyphotic angles significantly improved to lordosis after ELAP, resulting in favorable clinical outcomes. ELAP is a useful surgical option for patients even if they present mild kyphotic cervical angles.

scholarly journals The association of cervical sagittal alignment with adjacent segment degeneration

2019 ◽  
Vol 29 (11) ◽  
pp. 2655-2664 ◽  
Author(s):  
Xiaoyu Yang ◽  
Ronald H. M. A. Bartels ◽  
Roland Donk ◽  
Mark P. Arts ◽  
Caroline M. W. Goedmakers ◽  
...  
Keyword(s):  
Cervical Spine ◽  
Sagittal Alignment ◽  
Neck Disability Index ◽  
Adjacent Segment Degeneration ◽  
Adjacent Segment ◽  
Trial Register ◽  
Sf 36 ◽  
Cervical Sagittal Alignment ◽  
Intervertebral Cage

Abstract Purpose Cervical spine surgery may affect sagittal alignment parameters and induce accelerated degeneration of the cervical spine. Cervical sagittal alignment parameters of surgical patients will be correlated with radiological adjacent segment degeneration (ASD) and with clinical outcome parameters. Methods Patients were analysed from two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF) and without intervertebral cage (ACD). C2–C7 lordosis, T1 slope, C2–C7 sagittal vertical axis (SVA) and the occipito-cervical angle (OCI) were determined as cervical sagittal alignment parameters. Radiological ASD was scored by the combination of decrease in disc height and anterior osteophyte formation. Neck disability index (NDI), SF-36 PCS and MCS were evaluated as clinical outcomes. Results The cervical sagittal alignment parameters were comparable between the three treatment groups, both at baseline and at 2-year follow-up. Irrespective of surgical method, C2–C7 lordosis was found to increase from 11° to 13°, but the other parameters remained stable during follow-up. Only the OCI was demonstrated to be associated with the presence and positive progression of radiological ASD, both at baseline and at 2-year follow-up. NDI, SF-36 PCS and MCS were demonstrated not to be correlated with cervical sagittal alignment. Likewise, a correlation with the value or change of the OCI was absent. Conclusion OCI, an important factor to maintain horizontal gaze, was demonstrated to be associated with radiological ASD, suggesting that the occipito-cervical angle influences accelerated cervical degeneration. Since OCI did not change after surgery, degeneration of the cervical spine may be predicted by the value of OCI. NECK trial Dutch Trial Register Number NTR1289. PROCON trial Trial Register Number ISRCTN41681847. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow–Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee

2019 ◽  
Vol 47 (12) ◽  
pp. 2881-2887 ◽  
Author(s):  
Alex Quok An Teo ◽  
Keng Lin Wong ◽  
Liang Shen ◽  
Jia Ying Lim ◽  
Wei Seong Toh ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Tumor Formation ◽  
Chondral Defects ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background: The use of bone marrow–derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up. Purpose/Hypothesis: The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up. Study Design: Cohort study; Level of evidence, 2. Methods: Seventy-two patients who underwent either ACI or BMSC implantation—matched in terms of age and lesion site— were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation. Results: There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period. Conclusion: BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.

scholarly journals Is the improvement of cervical alignment really essential after three-level anterior cervical discectomy and fusion? A minimal 5-year follow-up

2020 ◽  
Author(s):  
Yan Liang ◽  
Shuai Xu ◽  
Guanjie Yu ◽  
Zhenqi Zhu ◽  
Haiying Liu
Keyword(s):  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Adjacent Segment Degeneration ◽  
Anterior Cervical Discectomy ◽  
Adjacent Segment ◽  
Cervical Discectomy ◽  
Cervical Alignment ◽  
Neck Disability

Abstract Purpose: To identify the importance of sagittal alignment with self-locked stand-alone cage (SSC) and anterior cage-with-plate (ACP) system after 3-level anterior cervical discectomy and fusion (ACDF) on cervical spondylotic myelopathy (CSM) after minimal 5-year follow-up.Methods: 38 patients with SSC system (SSC group) and 26 with ACP system (ACP group) from February 2007 to September 2013 were enrolled. Cervical alignment were C2-7 lordosis (CL), operated-segment CL (OPCL), upper and lower adjacent-segment CL (UCL and LCL) at preoperation (POP), immediate postoperation (IPO) and final follow-up (FFU). Clinical outcomes contained the neck disability index (NDI), the Japanese Orthopaedic Association (JOA) score and adjacent segment degeneration (ASD). Patients were divides into CL improved subgroup (IM subgroup) and non-improved subgroup (NIM subgroup).Results: There were improvements on CL and OPCL in both groups. The change of CL and OPCL larger in ACP group (P<0.05) but UAL and LAL were of no significance. NDI and JOA got improvement in both groups at IPO and FFU while ASD was in no difference between SSC and ACP. A total of 40 patients (18 vs 22) acquired CL improvement with a larger population in ACP group. There were no differences on the rate if ASD, NDI, JOA and their change between IM and NIM subgroup and the change of CL were not correlated with NDI, JOA and their change.Conclusion: SSC and ACP both provide long-term efficacy on OPCL correction with little impact on adjacent segment. The improvement of CL after three-level ACDF seems not so essential.

scholarly journals Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yingjun Guo ◽  
Hao Liu ◽  
Jianzhong Xu ◽  
Yuxiao Deng ◽  
Xiaoliang Tao ◽  
...  
Keyword(s):  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Operation Time ◽  
Cervical Disc ◽  
Adjacent Segment ◽  
Clinical Parameters ◽  
High Grade ◽  
Disc Prosthesis ◽  
Cervical Disc Prosthesis

Abstract Background The newly designed cervical disc prosthesis, Pretic-I, had been finished its limited clinical use for over 5 years. At a short-term follow-up of 2 years, we obtained satisfactory clinical results. The long-term clinical efficacy and safety of Pretic-I will now be analyzed. Methods Peri-operative parameters included intra-operative blood loss, operation time, off-bed time. Clinical parameters included visual analogue scale (VAS) for arm and neck, neck disability index (NDI), and Japanese Orthopaedic Association (JOA) score. Radiological parameters included C2–7 Cobb angle, Shell angle, and the range of motion (ROM) of C2–7, functional segment unit (FSU), and adjacent FSU. The CDA-related complications included adjacent segment degeneration (ASDeg), adjacent segment disease (ASDis), heterotopic ossification (HO), prosthesis subsidence, prosthesis displacement, and dysphagia. Results A total 64 patients from two independent centers received a single-level CDA with Discover (n = 32) and Pretic-I (n = 32), and all of patients finished a 5-year follow-up. There’re no significant differences between two groups in peri-operative parameters. The clinical parameters improved greatly in Pretic-I group (p<0.0001), and there’s no statistical difference from Discover group. Furthermore, Pretic-I could slightly improve the cervical curvature (15.08 ± 11.75 to 18.00 ± 10.61, p = 0.3079) and perfectly maintain the Shell angle (3.03 ± 3.68 to 2.23 ± 4.10, p = 0.1988), cervical ROM (52.48 ± 14.31 to 53.30 ± 11.71, p = 0.8062) and FSU ROM (12.20 ± 4.52 to 10.73 ± 4.45, p = 0.2002). The incidence of high-grade HO (Grade III-IV) at the final follow-up was significantly lower in Pretic-I group than in Discover group (12.50% vs. 34.38%, p = 0.0389, Statistical Power = 95.36%). The incidences of other CDA-related complications in Pretic-I group were also well-accepted, comparable to the Discover group, without significant differences. Conclusion CDA with Pretic-I demonstrated a well-accepted and sustained clinical outcome, with a significantly lower incidence of high-grade HO. This newly designed prosthesis is expected to become an alternative choice for cervical disc prosthesis in the future.

scholarly journals Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization

2018 ◽  
Vol 28 (4) ◽  
pp. 406-415 ◽  
Author(s):  
Sven Schmidt ◽  
Joerg Franke ◽  
Michael Rauschmann ◽  
Dieter Adelt ◽  
Matteo Mario Bonsanto ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Walking Distance ◽  
Pivotal Trial ◽  
Significant Difference ◽  
Patient Reported ◽  
Severe Adverse Events ◽  
Us Fda ◽  
Foraminal Height

OBJECTIVESurgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS.METHODSUnder approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany. Patients had moderate to severe LSS at 1 or 2 adjacent segments from L-3 to L-5. Outcomes were evaluated up to 2 years postoperatively, including Oswestry Disability Index (ODI) scores, the presence of secondary surgery or lumbar injections, neurological status, and the presence of device- or procedure-related severe adverse events. The composite clinical success (CCS) was defined as combining all 4 of these outcomes, a success definition validated in a US FDA pivotal trial. Additional secondary end points included visual analog scale (VAS) scores, Zürich Claudication Questionnaire (ZCQ) scores, narcotic usage, walking tolerance, and radiographs.RESULTSThe overall follow-up rate was 91% at 2 years. There were no significant differences in patient-reported outcomes at 24 months (p > 0.05). The CCS was superior for the D+ILS arm (p = 0.017). The risk of secondary intervention was 1.75 times higher among patients in the DA group than among those in the D+ILS group (p = 0.055). The DA arm had 228% more lumbar injections (4.5% for D+ILS vs 14.8% for DA; p = 0.0065) than the D+ILS one. Patients who underwent DA had a numerically higher rate of narcotic use at every time point postsurgically (16.7% for D+ILS vs 23% for DA at 24 months). Walking Distance Test results were statistically significantly different from baseline; the D+ILS group had > 2 times the improvement of the DA. The patients who underwent D+ILS had > 5 times the improvement from baseline compared with only 2 times the improvement from baseline for the DA group. Foraminal height and disc height were largely maintained in patients who underwent D+ILS, whereas patients treated with DA showed a significant decrease at 24 months postoperatively (p < 0.001).CONCLUSIONSThis study showed no significant difference in the individual patient-reported outcomes (e.g., ODI, VAS, ZCQ) between the treatments when viewed in isolation. The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure.Clinical trial registration no.: NCT01316211 (clinicaltrials.gov)

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