Trial reportSpine2007
Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.
Trial report in Spine, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01055574 (Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion), which is not on this map. Cited by 143 papers, 15 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial
Who cites it
143 citing papers in PubMed, 15 syntheses or guidelines pooled it, 459 citations in OpenAlex.
- Advanced meta-analyses comparing the three surgical techniques total disc replacement, anterior stand-alone fusion and circumferential fusion regarding pain, function and complications up to 3 years to treat lumbar degenerative disc disease.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2021Pooled it
- Total disc replacement versus fusion for lumbar degenerative diseases - a meta-analysis of randomized controlled trials.Medicine · 2019Pooled it
- Mid- to long-term results of total disc replacement for lumbar degenerative disc disease: a systematic review.Journal of orthopaedic surgery and research · 2018Pooled it
- Sexual activity after spine surgery: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2018Pooled it
- Lumbar total disc arthroplasty: outdated surgery or here to stay procedure? A systematic review of current literature.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2017Pooled it
- Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2017Pooled it
- Postural Balance Parameters as Objective Surgical Assessments in Low Back Disorders: A Systematic Review.Journal of applied biomechanics · 2016Pooled it
- Pain medication use after spine surgery: is it assessed in the literature? A systematic review, January 2000-December 2009.BMC research notes · 2015Pooled it
- Which design and biomaterial factors affect clinical wear performance of total disc replacements? A systematic review.Clinical orthopaedics and related research · 2014Pooled it
- Comparison of artificial total disc replacement versus fusion for lumbar degenerative disc disease: a meta-analysis of randomized controlled trials.International orthopaedics · 2013Pooled it
- Total disc replacement for chronic back pain in the presence of disc degeneration.The Cochrane database of systematic reviews · 2012Pooled it
- Low back pain (chronic).BMJ clinical evidence · 2010Pooled it
- Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2010Pooled it
- A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2010Pooled it
- [Current short- and long-term results of lumbar disc replacement : update 2008].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2008Pooled it
- Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2018Trial
- Lumbar total disc replacement by less invasive lateral approach: a report of results from two centers in the US IDE clinical trial of the XL TDR® device.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2015Trial
- Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis.BMC musculoskeletal disorders · 2014Trial
- Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2013Trial
- A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2013Trial
83 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by[Operations].2012
Authors and funding
23 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
designA prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.
objectiveTo evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1. SUMMARY OF BACKGROUND DATA: As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously.
methodsTwo hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation.
resultsSafety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees.
conclusionsProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.