Tag: RCT

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Transforaminal lumbar interbody fusion (TLIF) versus posterolateral instrumented fusion (PLF) in degenerative lumbar disorders

Eur Spine J (2013) 22:2022–2029

The aim of the present study was to analyze outcome, with respect to functional disability, pain, fusion rate, and complications of patients treated with transforaminal lumbar interbody fusion (TLIF) in compared to instrumented poserolateral fusion (PLF) alone, in low back pain. Spinal fusion has become a major procedure worldwide. However, conflicting results exist. Theoretical circumferential fusion could improve functional outcome. However, the theoretical advantages lack scientific documentation.

Methods Prospective randomized clinical study with a 2-year follow-up period. From November 2003 to November 2008, 100 patients with severe low back pain and radicular pain were randomly selected for either posterolateral lumbar fusion [titanium TSRH (Medtronic)] or transforaminal lumbar interbody fusion [titanium TSRH (Medtronic)] with anterior intervertebral support by tantalum cage (Implex/Zimmer). The primary outcome scores were obtained using Dallas Pain Questionnaire (DPQ), Oswestry disability Index, SF-36, and low back pain Rating Scale. All measures assessed the endpoints at 2-year follow-up after surgery.

Results The overall follow-up rate was 94 %. Sex ratio was 40/58. 51 patients had TLIF, 47 PLF. Mean age 49(TLIF)/45(PLF). No statistic difference in outcome between groups could be detected concerning daily activity, work leisure, anxiety/depression or social interest. We found no statistic difference concerning back pain or leg  pain. In both the TLIF and the PLF groups the patients had significant improvement in functional outcome, back pain, and leg pain compared to preoperatively. Operation time and blood loss in the TLIF group were significantly higher than in the PLF group (p \ 0.001). No statistic difference in fusion rates was detected.

Conclusions Transforaminal interbody fusion did not improve functional outcome in patients compared to posterolateral fusion. Both groups improved significantly in all categories compared to preoperatively. Operation time and blood loss were significantly higher in the TLIF group.

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Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting

Neurosurgery 92:481–489, 2023

Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery, but multicenter placebo-controlled trial data are necessary to determine its effectiveness.

OBJECTIVE: To evaluate the effectiveness of cerebrospinal fluid shunting in iNPH through comparison of open vs placebo shunting groups at 4 months using a pilot study.

METHODS: Patients were randomized to a Codman Certas Plus valve (Integra LifeSciences) set at 4 (open shunt group) or 8 (“virtual off”; placebo group). Patients and assessors were blinded to treatment group. The primary outcome measure was 10-m gait velocity. Secondary outcome measures included functional scales for bladder control, activities of daily living, depression, and quality of life. Immediately after 4-month evaluation, all shunts were adjusted in a blinded fashion to an active setting and followed to 12months after shunting.

RESULTS: A total of 18 patients were randomized. At the 4-month evaluation, gait velocity increased by 0.28 ± 0.28m/s in the open shunt group vs 0.04 ± 0.17m/s in the placebo group. The estimated treatment difference was 0.22 m/s ([P = .071], 95% CI 0.02 to 0.46). Overactive Bladder Short Form symptom bother questionnaire significantly improved in open shunt vs placebo (P = .007). The 4-month treatment delay did not reduce the subsequent response to active shunting, nor did it increase the adverse advents rate at 12 months.

CONCLUSION: This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, and found a trend suggesting gait velocity improves more in the open shunt group than in the placebo group.

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