Variation in reported safety of lumbar interbody fusion: Influence of industrial sponsorship and other study characteristics

Joshua J. Fenton, Sohail K. Mirza, Amnon Lahad, Benjamin D. Stern, Richard (Rick) Deyo

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

STUDY DESIGN. Systematic review. OBJECTIVE. To quantify variability in undesirable outcomes among studies of lumbar interbody fusion using stand-alone cage devices, and to determine whether author conflicts of interest contribute to variability. SUMMARY OF BACKGROUND DATA. Promising early studies of lumbar fusion with stand-alone cage devices led to rapid uptake of the technique, but some surgeons later expressed reservations regarding efficacy and safety. METHODS. We systematically identified studies of lumbar interbody fusion with stand-alone cage devices that reported at least one undesirable outcome among 10 or more adult subjects. We performed meta-analyses of rates of 7 prespecified outcomes (nonunion, reoperation, major vessel injury, retrograde ejaculation, neurologic injury, dural injury, and infection). Heterogeneity in outcome rates was quantified as I (the proportion of variance due to differences among studies rather than random variation). Random-effects meta-regression identified sources of observed heterogeneity, including potential conflicts of interest. RESULTS. We identified 30 eligible studies, including a total of 3228 subjects. A potential conflict of interest was identified in 18 (60%). We observed marked heterogeneity in rates of nonunion, reoperation, and neurologic injury (I > 85%; P <0.001), and substantial heterogeneity in rates of dural injury (I = 63%; P <0.01) and major vessel injury (I = 38%; P = 0.09). Among 24 studies reporting fusion status after 6 months of follow-up, nonunion rates ranged from 2.3% to 83.3% (median, 8.3%) and exceeded 45% in 4 studies. Potential author conflict of interest was associated with significantly lower rates of nonunion (P = 0.001). Heterogeneity in rates of other undesirable outcomes was not significantly associated with author conflicts of interest or other study characteristics. CONCLUSION. We quantified substantial unexplained variation in reported complication rates of undesirable outcomes of lumbar interbody fusion with stand-alone cage devices. Authors with potential conflicts of interest, however, reported significantly lower rates of nonunion.

Original languageEnglish (US)
Pages (from-to)471-480
Number of pages10
JournalSpine
Volume32
Issue number4
DOIs
StatePublished - Feb 2007
Externally publishedYes

Fingerprint

Conflict of Interest
Safety
Nervous System Trauma
Equipment and Supplies
Wounds and Injuries
Reoperation
Ejaculation
Meta-Analysis
Outcome Assessment (Health Care)
Infection

Keywords

  • Bias
  • Internal fixators
  • Lumbar fusion
  • Meta-analysis
  • Postoperative complications
  • Research support

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Variation in reported safety of lumbar interbody fusion : Influence of industrial sponsorship and other study characteristics. / Fenton, Joshua J.; Mirza, Sohail K.; Lahad, Amnon; Stern, Benjamin D.; Deyo, Richard (Rick).

In: Spine, Vol. 32, No. 4, 02.2007, p. 471-480.

Research output: Contribution to journalArticle

Fenton, Joshua J. ; Mirza, Sohail K. ; Lahad, Amnon ; Stern, Benjamin D. ; Deyo, Richard (Rick). / Variation in reported safety of lumbar interbody fusion : Influence of industrial sponsorship and other study characteristics. In: Spine. 2007 ; Vol. 32, No. 4. pp. 471-480.
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abstract = "STUDY DESIGN. Systematic review. OBJECTIVE. To quantify variability in undesirable outcomes among studies of lumbar interbody fusion using stand-alone cage devices, and to determine whether author conflicts of interest contribute to variability. SUMMARY OF BACKGROUND DATA. Promising early studies of lumbar fusion with stand-alone cage devices led to rapid uptake of the technique, but some surgeons later expressed reservations regarding efficacy and safety. METHODS. We systematically identified studies of lumbar interbody fusion with stand-alone cage devices that reported at least one undesirable outcome among 10 or more adult subjects. We performed meta-analyses of rates of 7 prespecified outcomes (nonunion, reoperation, major vessel injury, retrograde ejaculation, neurologic injury, dural injury, and infection). Heterogeneity in outcome rates was quantified as I (the proportion of variance due to differences among studies rather than random variation). Random-effects meta-regression identified sources of observed heterogeneity, including potential conflicts of interest. RESULTS. We identified 30 eligible studies, including a total of 3228 subjects. A potential conflict of interest was identified in 18 (60{\%}). We observed marked heterogeneity in rates of nonunion, reoperation, and neurologic injury (I > 85{\%}; P <0.001), and substantial heterogeneity in rates of dural injury (I = 63{\%}; P <0.01) and major vessel injury (I = 38{\%}; P = 0.09). Among 24 studies reporting fusion status after 6 months of follow-up, nonunion rates ranged from 2.3{\%} to 83.3{\%} (median, 8.3{\%}) and exceeded 45{\%} in 4 studies. Potential author conflict of interest was associated with significantly lower rates of nonunion (P = 0.001). Heterogeneity in rates of other undesirable outcomes was not significantly associated with author conflicts of interest or other study characteristics. CONCLUSION. We quantified substantial unexplained variation in reported complication rates of undesirable outcomes of lumbar interbody fusion with stand-alone cage devices. Authors with potential conflicts of interest, however, reported significantly lower rates of nonunion.",
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AU - Mirza, Sohail K.

AU - Lahad, Amnon

AU - Stern, Benjamin D.

AU - Deyo, Richard (Rick)

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N2 - STUDY DESIGN. Systematic review. OBJECTIVE. To quantify variability in undesirable outcomes among studies of lumbar interbody fusion using stand-alone cage devices, and to determine whether author conflicts of interest contribute to variability. SUMMARY OF BACKGROUND DATA. Promising early studies of lumbar fusion with stand-alone cage devices led to rapid uptake of the technique, but some surgeons later expressed reservations regarding efficacy and safety. METHODS. We systematically identified studies of lumbar interbody fusion with stand-alone cage devices that reported at least one undesirable outcome among 10 or more adult subjects. We performed meta-analyses of rates of 7 prespecified outcomes (nonunion, reoperation, major vessel injury, retrograde ejaculation, neurologic injury, dural injury, and infection). Heterogeneity in outcome rates was quantified as I (the proportion of variance due to differences among studies rather than random variation). Random-effects meta-regression identified sources of observed heterogeneity, including potential conflicts of interest. RESULTS. We identified 30 eligible studies, including a total of 3228 subjects. A potential conflict of interest was identified in 18 (60%). We observed marked heterogeneity in rates of nonunion, reoperation, and neurologic injury (I > 85%; P <0.001), and substantial heterogeneity in rates of dural injury (I = 63%; P <0.01) and major vessel injury (I = 38%; P = 0.09). Among 24 studies reporting fusion status after 6 months of follow-up, nonunion rates ranged from 2.3% to 83.3% (median, 8.3%) and exceeded 45% in 4 studies. Potential author conflict of interest was associated with significantly lower rates of nonunion (P = 0.001). Heterogeneity in rates of other undesirable outcomes was not significantly associated with author conflicts of interest or other study characteristics. CONCLUSION. We quantified substantial unexplained variation in reported complication rates of undesirable outcomes of lumbar interbody fusion with stand-alone cage devices. Authors with potential conflicts of interest, however, reported significantly lower rates of nonunion.

AB - STUDY DESIGN. Systematic review. OBJECTIVE. To quantify variability in undesirable outcomes among studies of lumbar interbody fusion using stand-alone cage devices, and to determine whether author conflicts of interest contribute to variability. SUMMARY OF BACKGROUND DATA. Promising early studies of lumbar fusion with stand-alone cage devices led to rapid uptake of the technique, but some surgeons later expressed reservations regarding efficacy and safety. METHODS. We systematically identified studies of lumbar interbody fusion with stand-alone cage devices that reported at least one undesirable outcome among 10 or more adult subjects. We performed meta-analyses of rates of 7 prespecified outcomes (nonunion, reoperation, major vessel injury, retrograde ejaculation, neurologic injury, dural injury, and infection). Heterogeneity in outcome rates was quantified as I (the proportion of variance due to differences among studies rather than random variation). Random-effects meta-regression identified sources of observed heterogeneity, including potential conflicts of interest. RESULTS. We identified 30 eligible studies, including a total of 3228 subjects. A potential conflict of interest was identified in 18 (60%). We observed marked heterogeneity in rates of nonunion, reoperation, and neurologic injury (I > 85%; P <0.001), and substantial heterogeneity in rates of dural injury (I = 63%; P <0.01) and major vessel injury (I = 38%; P = 0.09). Among 24 studies reporting fusion status after 6 months of follow-up, nonunion rates ranged from 2.3% to 83.3% (median, 8.3%) and exceeded 45% in 4 studies. Potential author conflict of interest was associated with significantly lower rates of nonunion (P = 0.001). Heterogeneity in rates of other undesirable outcomes was not significantly associated with author conflicts of interest or other study characteristics. CONCLUSION. We quantified substantial unexplained variation in reported complication rates of undesirable outcomes of lumbar interbody fusion with stand-alone cage devices. Authors with potential conflicts of interest, however, reported significantly lower rates of nonunion.

KW - Bias

KW - Internal fixators

KW - Lumbar fusion

KW - Meta-analysis

KW - Postoperative complications

KW - Research support

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