Tag: Randomized clinical trial

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Double-blind randomized clinical trial of vancomycin in spinal arthrodesis: no effects on surgical site infection

J Neurosurg Spine 32:473–480, 2020

Surgical site infection (SSI) results in high morbidity and mortality in patients undergoing spinal fusion. Using intravenous antibiotics in anesthesia induction reduces the rate of postoperative infection, but it is not common practice to use them topically, despite recent reports that this procedure helps reduce infection. The objective of this study was to determine whether the topical use of vancomycin reduces the rate of postoperative SSI in patients undergoing thoracolumbar fusion.

METHODS A randomized, double-blind clinical trial in a single hospital was performed comparing vancomycin and placebo in thoracolumbar fusion patients.

RESULTS A total of 96 patients were randomized to placebo or vancomycin treatment. The mean patient age was 43 ± 14.88 years, 74% were male, and the most common etiology was fall from height (46.9%). The overall rate of postoperative SSI was 8.3%, and no difference was found between the groups: postoperative infection rates in the vancomycin and placebo groups were 8.2% and 8.5% (relative risk [RR] of SSI not using vancomycin 1.04, 95% confidence interval [CI] 0.28–3.93, p = 0.951), respectively. Patients with diabetes mellitus had higher SSI rates (RR 8.98, 95% CI 1.81–44.61, p = 0.007).

CONCLUSIONS This is the first double-blind randomized clinical trial to evaluate the effects of topical vancomycin on postoperative infection rates in thoracolumbar fusion patients, and the results did not differ significantly from placebo. Clinical trial registration no.: RBR-57wppt (ReBEC; http://www.ensaiosclinicos.gov.br/)

 

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Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion”

PCM vs ACDF

Spine 2015;40:674–683

Study Design. Prospective, multicenter, randomized clinical trial.

Objective. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single- level degenerative spondylosis between C3–C4 and C7–T1 with or without prior cervical fusion.

Summary of Background Data. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.

Methods. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.

Results. At 5 years postoperative, all patient-reported outcomes— neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)—were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P = 0.001), neck pain (P = 0.002), general health (Pphysical component summary= 0.014; P mental component summary= 0.004), and patient satisfaction (P = 0.005).
PCM patients trended toward fewer 2- to 7-year device-related
serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P = 0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.

Conclusion. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
Level of Evidence: 1

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Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale

Cervical Spondylotic Myelopathy Surgical Trial- Randomized, Controlled Trial Design and Rationale

Neurosurgery 75:334–346, 2014

Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.

OBJECTIVE: To determine whether ventral surgery is associated with superior Short Form- 36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.

METHODS: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.

EXPECTED OUTCOMES: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.

DISCUSSION: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.

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No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy

Eur Spine J (2009) 18:1843–1850 DOI 10.1007/s00586-009-1044-3

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non- invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person’s body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (±25) to 32 (±27) with the IDD protocol and 53 (±26) to 36 (±27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.

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