711295 - Biologics and Minimally Invasive Approach to TLIFs – What Is the Risk of Radiculitis?

Thursday, February 27, 2020

8:15 AM – 8:20 AM

Location: Ballroom B

Participants should be aware of the following financial/non-financial relationships:

Carolyn Stickley, BS: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Aaron J. Buckland, MD: EOS imaging (Individual(s) Involved: Self, Products/Services: Consultancy): Consultancy; Medtronic (Individual(s) Involved: Self, Products/Services: Consultancy): Consultancy; NuVasive (Individual(s) Involved: Self, Products/Services: Consultancy): Consultancy; Stryker Spine (Individual(s) Involved: Self, Products/Services: Consutancy): Consultancy

Erik Wang, BA: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Jordan Manning: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Christopher G. Varlotta, BS: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Dainn Woo, BS: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Ethan W. Ayres, MPH: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Edem Abotsi: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Dennis Vazquez-Montes, MS: Disclosure information not submitted.

Charla R. Fischer, MD: LifeSpine (Individual(s) Involved: Self, Products/Services: Spine): Consultant; Stryker (Individual(s) Involved: Self, Products/Services: spine): consultant; Zimmer Biomet (Individual(s) Involved: Self, Products/Services: Spine): Consultant

Jonathan R. Stieber, MD: Stryker Spine (Individual(s) Involved: Self, Products/Services: Teaching, Product Development, Consulting): Consultant Income/Hourly

Themistocles S. Protopsaltis, MD: Altus Spine (Individual(s) Involved: Self, Products/Services: N/A): Royalties; Globus Medical (Individual(s) Involved: Self, Products/Services: N/A): Consulting; Innovasis (Individual(s) Involved: Self, Products/Services: N/A): Consulting; Medicrea (Individual(s) Involved: Self, Products/Services: N/A): Consulting; NuVasive (Individual(s) Involved: Self, Products/Services: N/A): Consulting, Consulting; Stryker/K2M (Individual(s) Involved: Self, Products/Services: N/A): Consulting

Peter G. Passias, MD: AlloSource (Individual(s) Involved: Self, Products/Services: Financial Support): Financial Support; Globus Medical (Individual(s) Involved: Self, Products/Services: Paid Presenter or Speaker): Paid Presenter or Speaker; Medicrea (Individual(s) Involved: Self, Products/Services: N/a): Paid consultant; SpineWave (Individual(s) Involved: Self, Products/Services: Paid Consultant): Paid consultant; The Cervical Spine Research Society (Individual(s) Involved: Self, Products/Services: Grant): Grant; Zimmer Biomet (Individual(s) Involved: Self, Products/Services: Paid Presenter or Speaker): Paid Presenter or Speaker

Introduction: Recombinant human bone morphogenetic protein 2 (rhBMP-2) and bone allograft containing human mesenchymal stem cells (live cell) are popular biologic products used in transforaminal lumbar interbody fusion (TLIF) to promote fusion and avoid the morbidity of using iliac crest autograft. However, use of these agents in the pathogenesis of postoperative radiculitis remains controversial. Recent studies have also independently linked minimally invasive (MIS) TLIF with increased radiculitis risk compared to open TLIF.

Purpose: To assess the rate of postoperative radiculitis in open and MIS TLIF patients along with its relationship to concurrent biologic adjuvant use

Methods: Patients ≥18 years old undergoing single-level TLIF from September 2012 to June 2018 with minimum one-year follow-up included. Chart review was performed for operative dates and details, perioperative outcomes and patient follow-up information. Postoperative radiculitis was defined as new radicular symptoms after initial improvement postoperatively, without persistent neurological compression on postoperative imaging. Univariate analysis and multivariate logistic regression analysis for categorical variables and one-way ANOVA for continuous variables were utilized to evaluate characteristics in association with development or not- of postoperative radiculitis. Significance was set at p<0.05. Propensity score matching (PSM) controlling for age, gender, BMI and CCI was utilized to compare paired open and MIS groups.

Results: 317 patients were included (48.90% female, age 58.33±14.08 years, BMI 28.85±5.71 kg/m2, Charlson comorbidity index [CCI] 1.01±1.46); comprising of 197 open TLIFs and 120 MIS TLIFs. 138 surgeries utilized BMP, 26 with live cell and 153 with neither. Postoperative radiculitis occurred in 17 patients (5.36% overall): 12 cases MIS with BMP (14.29% of their cohort), 1 MIS without BMP (4.76%), 3 open with BMP (5.56%), 1 open without BMP (0.76%). When comparing MIS vs open TLIF, open TLIF had higher mean estimated blood loss (EBL) (385.66. vs. 173.33 ml, p<0.001), LOS (4.04 vs. 2.73 days, p<0.001), CCI (1.21 vs. 0.67, p=0.001) and age (59.93 vs. 55.72 years, p=0.010) than MIS patients. Of the 17 observed cases of postoperative radiculitis, 13 were MIS cases (10.83%) and 4 were open cases (2.03%; p=0.001 for both). No significant differences were identified in one-year reoperation rates (12.69% vs. 8.33%, p=0.230), infection or wound complication (1.60% vs. 0.89%, p=0.604) or pseudarthrosis (3.21% vs. 1.79%, p=0.461), but higher overall rate of postoperative complications (22.56% vs. 11.30%, p=0.013) was noted in open TLIF. Comparing BMP vs non-BMP, of the 17 observed cases of postoperative radiculitis, 13 utilized BMP (9.42%) and 4 did not use BMP (2.23%; p=0.005). No significant differences in reoperation rates (12.29% vs 9.42%, p=0.419), infection or wound complication (1.23% vs. 1.47%, p=0.855), pseudarthrosis (4.29% vs. 0.74%, p=0.058) or overall rate of postoperative complications (20.81% vs. 15.33%, p=0.216) were noted. Multivariate logistic regression used to determine independent predictors for postoperative radiculitis. BMP use and open versus MIS technique were compared before and after matching for age, gender, BMI and CCI. Neither BMP use nor MIS technique found to be independent predictors of postoperative radiculitis (BMP p=0.089, MIS p=0.181), but the combination of BMP and MIS technique predicted a risk for postoperative radiculitis (OR: 5.923[1.965–17.853], p=0.002, N=317). After propensity matching open and MIS groups (N=106 each), these variables were still not independently associated with radiculitis (BMP p=0.195, MIS p=0.138). However, the combination of MIS with BMP was associated with increased radiculitis risk after matching (OR: 7.984[1.677–38.019], p=0.009, N=212) compared to other combinations of surgical approach and biologic use.

Conclusion: Neither MIS approach nor BMP use are independent risk factors for post-TLIF radiculitis. However, risk of radiculitis significantly increases when they are used in tandem. This should be considered when selecting biological adjuvants for MIS TLIF.

Presenting Author(s)

Carolyn Stickley, BS

Research Fellow
NYU Langone Health

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

Aaron J. Buckland, MD

Associate Professor of Orthopedic Surgery, Director of Spine Research
NYU Langone Health

Disclosure: EOS imaging : Consultancy (Status: Ongoing); Medtronic : Consultancy (Status: Ongoing); NuVasive : Consultancy (Status: Ongoing); Stryker Spine : Consultancy (Status: Ongoing)
Erik Wang, BA

Research Fellow
NYU Langone Health

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Jordan Manning

Research Fellow
NYU Langone Health

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Christopher G. Varlotta, BS

Research Fellow
NYU Langone Orthopedic Hospital

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Dainn Woo, BS

Research Fellow
NYU Langone Health

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Ethan W. Ayres, MPH

Research Fellow
NYU Langone Orthopedic Hospital

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Edem Abotsi

NYU Langone Orthopedic Hospital

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Dennis Vazquez-Montes, MS

NYU Langone Orthopaedic Hospital

Disclosure: Disclosure information not submitted.
Charla R. Fischer, MD

Associate Professor
NYU Langone Orthopedic Hospital

Disclosure: LifeSpine : Consultant (Status: Ongoing); Stryker : consultant (Status: Ongoing); Zimmer Biomet : Consultant (Status: Ongoing)
Jonathan R. Stieber, MD

Clinical Assistant Professor of Orthopedic Surgery
NYU Langone Health

Disclosure: Stryker Spine : Consultant Income/Hourly (Status: Ongoing)
Themistocles S. Protopsaltis, MD

Chief, Division of Spine Surgery, Department of Orthopaedic Surgery
New York University Langone Orthopedic Hospital

Disclosure: Altus Spine : Royalties (Status: Ongoing); Globus Medical : Consulting (Status: Ongoing); Innovasis : Consulting (Status: Ongoing); Medicrea : Consulting (Status: Ongoing); NuVasive : Consulting (Status: Ongoing), Consulting (Status: Ongoing); Stryker/K2M : Consulting (Status: Ongoing)
Peter G. Passias, MD

Associate Professor NYU School of Medicine
NYU Langone Orthopedic Hospital

Disclosure: AlloSource : Financial Support (Status: Ongoing); Globus Medical : Paid Presenter or Speaker (Status: Ongoing); Medicrea : Paid consultant (Status: Ongoing); SpineWave : Paid consultant (Status: Ongoing); The Cervical Spine Research Society : Grant (Status: Ongoing); Zimmer Biomet : Paid Presenter or Speaker (Status: Ongoing)