Dataset Information

Novel use of robotics and navigation for anterior lumbar total disc replacement surgery.

ABSTRACT: The ability to navigate the anterior lumbar disc space may improve clinical outcomes and implant longevity. However, no robotic navigation systems are presently authorized by the U.S. Food and Drug Administration to assist with anterior retroperitoneal lumbar interbody surgery. Furthermore, no studies to date have investigated such an application of this technology. This study examines the application of robotic navigation to anterior lumbar total disc replacement surgery to improve retroperitoneal exposure and orientation of the anterior lumbar spine, enhance coronal plane centralization of the implant, optimize surgical trajectory, and mitigate radiologic exposure. Postoperative outcomes of a small cohort of patients undergoing anterior lumbar total disc replacement surgery using robotic navigation were analyzed. The results of the study revealed that a modified use of the aforementioned robot-assisted surgical technology enhances coronal plane centralization and trajectory, all while mitigating radiologic exposure, resulting in more accurate placement of the implant within the intervertebral space at each level.

SUBMITTER: Balboni JM

PROVIDER: S-EPMC8820011 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Novel use of robotics and navigation for anterior lumbar total disc replacement surgery.

Balboni Julia M JM Siddique Khawar K Nomoto Edward K EK Wong Albert P AP Yashar Parham P Hill Patrick S PS Smith Robert R Perri Kristen K Perri Brian R BR

North American Spine Society journal 20220105

The ability to navigate the anterior lumbar disc space may improve clinical outcomes and implant longevity. However, no robotic navigation systems are presently authorized by the U.S. Food and Drug Administration to assist with anterior retroperitoneal lumbar interbody surgery. Furthermore, no studies to date have investigated such an application of this technology. This study examines the application of robotic navigation to anterior lumbar total disc replacement surgery to improve retroperiton ...[more]

PMID: 35141661

Similar Datasets

Project description:BackgroundThe motion preserving benefits of lumbar total disc replacement (LTDR) are well established. There is a paucity of long-term follow-up data on the M6-L prosthesis. The aim was to evaluate the clinical and radiographic outcomes of patients undergoing LTDR with M6-L and make comment about its effectiveness and durability.MethodsA retrospective single center chart review was performed of all patients who underwent LTDR with M6-L between January 1, 2011, and January 1, 2021, either as standalone device or combined with a caudal anterior lumbar interbody fusion (ALIF) (hybrid procedure). Preoperative, postoperative, and final follow-up patient reported outcome measures (PROMs) (VAS back, VAS leg, ODI, and SF-12) and patient satisfaction were recorded prospectively. Device range of motion (ROM), adjacent segment degeneration/disease and heterotopic ossification (HO) were obtained from flexion and extension lumbar radiographs at most recent follow-up.ResultsSixty patients underwent LTDR with the M6-L device. Mean age was 41 [16-71] years and 38 (63%) were male. Sixteen (26.7%) underwent standalone LTDR, 42 (70.0%) a hybrid procedure, and 2 (3.3%) a 3-level procedure. Twenty-three (38.3%) patients were lost to follow-up. Thirty-seven (61.7%) were followed for a mean of 4.3 [1-10] years with 36/37 reviewed at a minimum of 2-years and 13/37 followed for over 5-years. Only one patient with osteopenia needed index level revision LTDR surgery for subsidence requiring supplemental posterior instrumentation. There were no osteolysis induced device related failures. Thirty patients obtained long-term follow-up radiographic data. Six patients had adjacent segment degeneration; none required surgery for adjacent segment disease (ASD). Three patients presented with clinically significant HO (2 with McAfee class III, 1 with class IV). The average M6-L ROM was 8.6 degrees. Mean preoperative baseline PROMs demonstrated statistically significant improvements postoperatively and were sustained at last follow-up (P<0.05).ConclusionsTotal disc replacement (TDR) with M6-L showed clinically significant improvement in PROMs that were sustained at long-term follow-up. There were no osteolysis induced device related failures. The device ROM was maintained and showed a downward trend over the 10-year study follow-up period. This paper demonstrated that the M6-L was an effective and durable arthroplasty device in this series.

Project description:PurposeTo systematically compare the efficacy and safety of lumbar total disc replacement (TDR) with the efficacy and safety of anterior lumbar interbody fusion (ALIF) for the treatment of lumbar degenerative disc disease (LDDD).MethodsThe electronic databases PubMed, Web of Science and the Cochrane Library were searched for the period from the establishment of the databases to March 2018. The peer-reviewed articles that investigate the safety and efficacy of TDR and ALIF were retrieved under the given search terms. Quality assessment must be done independently by two authors according to each item of criterion. The statistical analyses were performed using RevMan (version 5.3) and Stata (version 14.0). The random-effect model was carried out to pool the data. The I2 statistic was used to evaluate heterogeneity. The sensitivity analysis was carried out to assess the robustness of the results of meta-analyses by omitting the articles one by one.ResultsSix studies (5 randomized controlled trials (RCT) and 1 observational study) involving 1093 patients were included in this meta-analysis. The risk of bias of the studies could be considered as low to moderate. Operative time (MD = 4.95; 95% CI -18.91-28.81; P = 0.68), intraoperative blood loss (MD = 4.95; 95% CI -18.91-28.81; P = 0.68), hospital stay (MD = -0.33; 95% CI, -0.67-0.01; P = 0.05), complications (RR = 0.96; 95% CI 0.91-1.02; P = 0.18) and re-operation rate (RR = 0.54; 95% CI 0.14-2.12; P = 0.38) were without significant clinical difference between groups. Patients in the TDR group had higher postoperative satisfaction (RR = 1.19; 95% CI 1.07-1.32; P = 0.001) and, better improvements in ODI (MD = -10.99; 95% CI -21.50- -0.48; P = 0.04), VAS (MD = -10.56; 95% CI -19.99- -1.13; P = 0.03) and postoperative lumbar mobility than did patients in the ALIF group.ConclusionsThe results showed that TDR has significant superiority in term of reduced clinical symptoms, improved physical function and preserved range of motion for the treatment of LDDD compared to ALIF. TDR may be an ideal alternative for the selected patients with LDDD in the short-term. However, the results of this study cannot suggest the use of TDR instead of ALIF in lumbar spine treatment only in the light of short term results. More studies that are well-designed, that are of high-quality and that have larger samples are needed to further evaluate the efficacy and safety of TDR with at the long-term follow-up.Level of evidenceTherapeutic Level 3.

Project description:BackgroundLumbar total disc replacement (TDR) has produced results similar or superior to fusion in treating symptomatic disc degeneration. Some patients have reported onset of leg pain early after surgery. Little information is available specifically on this problem. The purpose of this study was to investigate the incidence of early-onset postoperative leg pain following lumbar TDR and to describe strategies for its treatment.MethodsThe study was based on a post hoc analysis of prospectively collected adverse event data from 283 patients in the activL Food and Drug Administration investigational device exemption study. Early-onset leg pain was defined as occurring between 0 and 4 weeks postprocedure, and the baseline visual analog scale score in the affected leg(s) was <25 (of 100). The treatment types these patients received were analyzed.ResultsAmong 283 patients, 26 (9.2%) had an early-onset leg pain event. The majority of these events resolved (20/26, 76.9%). Of those resolving, 55% (11/20) did so within 3 months. Most patients received at least 1 drug treatment for leg pain (92.3%). Of those receiving drug therapy, the most common type was neurogenic (61.5%), followed by narcotics (46.2%). Steroid use was prescribed in 30.8%. The majority of resolved cases were not on narcotics and resolved with neurogenic drugs. Three patients went on to have surgery, none of whom benefited from it. Age, body mass index, and baseline disability scores were predictive of time to resolution.ConclusionEarly-onset postoperative leg pain occurred in approximately 10% of lumbar TDR patients. The majority of events resolved, often within 3 months. Treatment with conservative care, including medication(s), was more effective in resolving symptoms rather than surgery.Clinical relevanceThis study provides useful information for providers and patients on the incidence, treatment, and resolution of leg pain with onset after lumbar TDR and not related to direct neural compression identified by imaging.Level of evidence2.

Dataset Information

Novel use of robotics and navigation for anterior lumbar total disc replacement surgery.

Publications

Novel use of robotics and navigation for anterior lumbar total disc replacement surgery.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets