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Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

ABSTRACT: Background:The purposes of the present study were to (1) confirm the risk of recurrent lumbar disc herniation in patients with a large anular defect who had undergone limited discectomy and (2) assess potential risk factors within this population. Methods:The patient population was extracted from the control cohort of a prospective, randomized, multicenter controlled trial investigating the efficacy of an anular closure device following standard limited discectomy. All control patients underwent limited discectomy for the treatment of a single-level symptomatic posterior or posterolateral lumbar disc herniation. Only patients presenting with a large anular defect (6 to 10 mm wide by 4 to 6 mm long) were included in the study (n = 278). Baseline demographic, clinical, and surgical characteristics were recorded. Follow-up evaluations were performed at 6 weeks and at 3, 6, 12, and 24 months. Imaging modalities included magnetic resonance imaging, low-dose computed tomography, and radiographs. Symptomatic recurrent lumbar disc herniation was defined as any symptomatic postoperative herniation on either side of the index level. A multivariate logistic regression analysis of demographic and surgical variables associated with the incidence of recurrent lumbar disc herniation was performed. Results:The mean anular defect area (and standard deviation) was 39.3 ± 9.1 mm2, and the mean excised nuclear tissue volume was 1.3 ± 0.8 mL. At 2 years, the incidence of symptomatic recurrent lumbar disc herniation was 25.3% (64 of 253), with the herniation occurring at a mean of 264 days after the index procedure. Of the 64 patients with recurrent lumbar disc herniation, 36 underwent a subsequent surgical procedure. Logistic regression analysis identified an increased risk for recurrent lumbar disc herniation in females (odds ratio, 2.2) and in patients with greater anular defect widths (odds ratio, 1.3). Furthermore, multivariate logistic regression analyses revealed a significant interaction between age and sex (p = 0.005). Conclusions:The outcomes of the present study provide the most substantial evidence to date in confirming previous reports of a high risk of reherniation among patients with large anular defects. Among those with large anular defects (width, ?6 mm), females ?50 years of age had the highest risk (up to ?10 times higher) of recurrent lumbar disc herniation. It is recommended that an anular repair or closure should be performed after limited discectomies in patients with large anular defects. Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Martens F

PROVIDER: S-EPMC6145569 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

Martens Frederic F Vajkoczy Peter P Jadik Senol S Hegewald Aldemar A Stieber Jonathan J Hes Robert R

JB & JS open access 20180416 2

<h4>Background</h4>The purposes of the present study were to (1) confirm the risk of recurrent lumbar disc herniation in patients with a large anular defect who had undergone limited discectomy and (2) assess potential risk factors within this population.<h4>Methods</h4>The patient population was extracted from the control cohort of a prospective, randomized, multicenter controlled trial investigating the efficacy of an anular closure device following standard limited discectomy. All control pat ...[more]

PMID: 30280130

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Project description:BACKGROUND:A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation. METHODS:This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board. RESULTS:Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P?<?0.001), reoperation (11.0% vs. 19.3%; P?=?0.007), leg pain (21 vs. 30; P?<?0.01), back pain (23 vs. 30; P?=?0.01), ODI (18 vs. 23; P?=?0.02), PCS (47 vs. 44; P?<?0.01), and MCS (52 vs. 49; P?<?0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P?=?0.61). CONCLUSIONS:The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only. TRIAL REGISTRATION:ClinicalTrials.gov NCT01283438.

Project description:BACKGROUND:Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. DESIGN AND METHODS:This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. ETHICS AND DISSEMINATION:This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. STUDY REGISTRATION:ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. LEVEL OF EVIDENCE:3.

Project description:BackgroundFenestration discectomy, for symptomatic lumbar disc herniation, is the most common surgical procedure in spine surgery. It can be done by open or microscopic procedures. This study compared the results of fenestration microdiscectomy with open fenestration discectomy in the treatment of symptomatic lumbar disc herniation as a relation to the functional outcome, leg pain, back pain, hospital stay, returns to daily activity, cost, recurrence, reoperation and type of surgery for recurrent disc herniation.Methods60 patients age (29 - 50 years), with L4-L5 disc herniation, are divided randomly into group A- 30 patients underwent an open fenestration discectomy- and group B- 30 patients underwent fenestration microdiscectomy. All patients are assessed at 1 week, 3 months, 6 months, 12 months after surgery for Oswestry disability index and Visual analogue scale for back pain and leg pain and followed up for 4 years.ResultsIn both groups, all patients have minimal disability by Oswestry Disability Index after surgery. There were significant differences between means of post-operative Visual Analogue Scale for back pain between these two groups after 1 week (3.7 in group A versus 2.2 in group B) (t = 13.28, P = < 0.001*) and after 3 months (1.73 in group A versus 0.43 in group B) (t = 10.54, P = < 0.001*). There were no significant differences between two groups regarding post-operative VAS for leg pain, recurrence (5 patients in group A versus 4 patients in group B) and reoperation rate (2 patients in each group). There were significant differences between means of length of hospital stay (2.10 in group A versus 1.06 in group B) (P < 0.001), time of returning to daily activities (7.33 in group A versus 4.03 in group B) (P < 0.001) and cost of surgery (1996.66 in group A versus 3003.3 in group B) (P < 0.001).ConclusionUse of microscope in fenestration discectomy for treatment of symptomatic lumbar disc herniation can achieve the same goals of open fenestration regarding nerve root decompression and relief of leg pain with advantage of less back pain, less hospital staying and early return to daily activities with disadvantage of more cost with the use of microscope. With 4 years follow up, there was no significant deference in rate of recurrence and reoperation with the use of microscope but we found that type of surgery for recurrent cases may be less invasive if microscope was used in primary surgery.Trial registrationNCT, NCT04112485. Registered 30 September 2019 - Retrospectively registered, https://clinicaltrials.gov/NCT04112485.

Project description:ObjectivesTo evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components.Design and settingA feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.ParticipantsConsecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.InterventionsParticipants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Main outcome measuresBlinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.ResultsAt discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported.ConclusionsBoth interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome.Trial registrationISRCTN registry 33808269.

Dataset Information

Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

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Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

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