Evidence map›Paper›PMID 16025024›Full record

Trial reportSpine2005

A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.

Scott Blumenthal, Paul C McAfee, Richard D Guyer, Stephen H Hochschuler, Fred H Geisler, Richard T Holt, Rolando Garcia, John J Regan, Donna D Ohnmeiss

Erratum issued 2 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Spine, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 158 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
158citing papers in PubMed, 18 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT00215306 phase3completednot on this map

Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.

TypeinterventionalSponsorDePuy SpineRan2000 to 2004Enrolled304ConditionsDegenerative Disc DiseaseArmsCHARITÉ Artificial Disc, Anterior Interbody Fusion with BAK Cage
NCT01055574 terminatednot on this mapstarted 2009, after this paper: background citation

Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial

TypeobservationalSponsorGundersen Lutheran Medical FoundationRan2009 to 2012Enrolled45ConditionsPhysical Capability Outcomes
3 · Its place in the literature

Who cites it

158 citing papers in PubMed, 18 syntheses or guidelines pooled it.

  1. The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion 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 · 2024
    Pooled it
  2. 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 · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. 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 · 2018
    Pooled it
  6. Pooled it
  7. 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 · 2017
    Pooled it
  8. Pooled it
  9. 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 · 2017
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Low back pain (chronic).BMJ clinical evidence · 2010
    Pooled it
  14. 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 · 2010
    Pooled it
  15. 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 · 2010
    Pooled it
  16. [Current short- and long-term results of lumbar disc replacement : update 2008].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2008
    Pooled it
  17. Total disc replacement in the lumbar spine: 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 · 2006
    Pooled it
  18. Methodological aspects of outcomes research.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 · 2006
    Pooled it
  19. Trial
  20. 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 · 2018
    Trial

98 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Scott BlumenthalTexas Back Institute, Plano, Texas 75093, USA. sblumenthal@texasback.com
Paul C McAfee
Richard D Guyer
Stephen H Hochschuler
Fred H Geisler
Richard T Holt
Rolando Garcia
John J Regan
Donna D Ohnmeiss

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designA prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.

objectivesThe purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. SUMMARY OF BACKGROUND DATA: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes.

methodsThree hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey.

resultsPatients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups.

conclusionsThis prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.

Indexed as

Intervertebral DiscProstheses and ImplantsSpinal FusionAdultDisability EvaluationEmploymentFemaleFollow-Up StudiesHumansIntervertebral Disc DisplacementLow Back PainLumbar VertebraeMaleMiddle AgedNarcoticsPain MeasurementNarcotics

Identifiers

PMID16025024

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.