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Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

ABSTRACT: Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits.The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided.New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.ClinicalTrials.gov: NCT01224379.

SUBMITTER: Siewe J

PROVIDER: S-EPMC3214157 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

Siewe Jan J Otto Christina C Knoell Peter P Koriller Marco M Stein Gregor G Kaulhausen Thomas T Eysel Peer P Zarghooni Kourosh K Franklin Jeremy J Sobottke Rolf R

BMC musculoskeletal disorders 20111018

<h4>Background</h4>Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence t ...[more]

PMID: 22008088

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Project description:BackgroundCurrent guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes.MethodsThis study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary outcome measure is Oswestry Disability Index. Secondary outcome measures are the visual analogue scale for back and leg pain, pain drawing, health related quality of life, Hospital anxiety and depression scale, Fear avoidance beliefs questionnaire, Self-efficacy scale and Work Ability Index.DiscussionThe study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.Trial registrationClinicalTrials.gov reference: NCT02454400 (Trial registration date: August 31st 2015) and has been registered on ClinicalTrials.gov, identifier: NCT02454400 .

Project description:Study Design Randomized controlled trial. Objective Despite a large number of publications of outcomes after spinal fusion surgery, there is still no consensus on the efficacy of the several different fusion methods. The aim of this study was to determine whether transforaminal lumbar interbody fusion (TLIF) results in an improved clinical outcome compared with uninstrumented posterolateral fusion (PLF) in the surgical treatment for chronic low back pain. Methods This study included 135 patients with degenerative disk disease (n = 96) or postdiskectomy syndrome (n = 39). Inclusion criteria were at least 1 year of back pain with or without leg pain in patients aged 20 to 65 with one- or two-level disease. Exclusion criteria were sequestration of disk hernia, psychosocial instability, isthmic spondylolisthesis, drug abuse, and previous spine surgery other than diskectomy. Pain was assessed by visual analog scale (pain index). Functional disability was quantified by the disability rating index and Oswestry Disability Index. The global outcome was assessed by the patient and classified as much better, better, unchanged, or worse. The patients were randomized to conventional uninstrumented PLF (n = 67) or TLIF (n = 68). PLF was performed in a standardized fashion using autograft. TLIF was performed with pedicle titanium screw fixation and a porous tantalum interbody spacer with interbody and posterolateral autograft. The clinical outcome measurements were obtained preoperatively and at 12 and 24 months postoperatively. The 2-year follow-up rate was 98%. Results The two treatment groups improved significantly from preoperatively to 2 years' follow-up. At final follow-up, the results in the TLIF group were significantly superior to those in the PLF group in pain index (2.0 versus 3.9, p = 0.007) and in disability rating index (22 versus 36, p = 0.003). The Oswestry Disability Index was better in the TLIF group (20 versus 28, p = 0.110, not significant). The global assessment was clearly superior in the TLIF group: 63% of patients scored "much better" in the TLIF group as compared with 48% in the PLF group (p = 0.017). Conclusions The results of the current study support the use of TLIF rather than uninstrumented PLF in the surgical treatment of the degenerative lumbar spine. The less optimal outcome after uninstrumented PLF may be explained by the much higher reoperation rate.

Project description:Objective:Ultrasound-guided lateral thoracolumbar interfascial plane block (US-TLIP block) is a novel regional technique for anesthesia or analgesia. However, there has been no prospective, randomized and controlled clinical trial investigating the perioperative analgesic effect of US-TLIP block on lumbar spinal fusion surgery. The aim of this study was to investigate the analgesic effect of bilateral single-shot US-TLIP in patients undergoing lumbar spinal fusion surgery. Methods:A prospective and randomized comparative clinical study was conducted. A total of 60 patients (ASA classes: I-II), aged 21-74 years who were scheduled for lumbar spinal fusion surgery were randomized and divided into the TLIP group (Group T, n = 30) and control group (Group C, n = 30). The patients in Group T received preoperative bilateral single-shot US-TLIP with 30 ml of 0.375% ropivacaine at the third lumbar spine (L3) vertebral level, and the patients in Group C received an injection of 30 ml 0.9% saline through same technique. All patients received patient-controlled analgesia (PCA) after their operation. The frequency of PCA compressions and rescue analgesic administrations were recorded. Opioids (sufentanil and remifentanil), anesthetic consumption, the number of postoperative days spent in a hospital bed, overall hospital stay time and postoperative complications were recorded. The Visual Analogue Scale (VAS) and Bruggemann Comfort Scale (BCS) scores for pain and comfort assessment were recorded at 1, 12, 24, 36, and 48 hours postoperatively. Results:Opioids and anesthetic consumption in the perioperative period decreased significantly in the TLIP group compared to the control group (P < 0.05). The VAS and BCS scores in the TLIP group were lower at 12, 24, and 36 hours postoperatively (P < 0.05). US-TLIP block has been shown to shorten postoperative hospital stays (P < 0.05). There was no significant difference in postoperative complications between the two groups. Conclusion:Our study findings show that bilateral US-TLIP block exhibits significant analgesia and safety in patients undergoing lumbar spinal fusion surgery.

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Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

Publications

Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

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