Cervical fusion for treatment of degenerative conditions: development of appropriate use criteria

Publication history

Footnotes

FDA Device/Drug Note: The manuscript does not discuss any drugs or devices requiring FDA approval.

Author disclosures: CAR: Nothing to disclose. JMH: Nothing to disclose. CJS: Consulting: Washington State Health Care Authority Health Technology Clinical Committee (A per meeting (one day), 4-5 meetings per year), BCBS Association (A for serving as Expert Panelist regarding the BCBS Association Blue Distinction Centers for Spine Surgery August 2011). CMB: Royalties: Wolters Kluwer (B, royalties for edited book), Informa Healthcare (B, royalties for edited book); Consulting: Harvard Clinical Research Institute (Reimbursed for time as part of the Trial Design Team, developing and implementing protocols for spine research); Other Office: Barricaid (data safety monitoring board, no remuneration yet, for prospective study of new device), JAAOS (B, Deputy Editor), The Spine Journal (Nonfinancial, Deputy Editor). CAM: Nothing to disclose. CGF: Nothing to disclose. CPK: Speaking and/or teaching arrangements: NASS (Course Director/Instructor NASS Coding Course, Travel/lodging reimbursed). DKR: Board of Directors: CNS (Nonfinancial); Scientific Advisory Board: Neurosurgical Research Foundation (Nonfinancial); Grants: AANS Spine Section (D, research grant through AANS, paid directly to institution/employer). DAW: Royalties: Lippincott Williams and Wilkins (A); Stock Ownership: Neurotech/CervIOM (20, 20), Denver Integrated Imaging North (20, 1), Huron Shores LLC (50, 50); Consulting: Anulex (B), Allosource (A), Deroyal (Financial, 0), United Healthcare (A); Speaking and/or teaching arrangements: Anulex (Financial, 0); Trips/Travel: Deroyal (A); Scientific Advisory Board: United Healthcare (A); Research Support (Staff/Materials): Abbott (B), Anulex (B), Cervitech/Nuvasive (A). HP: Board of Directors: NASS (Nonfinancial, reimbursed for travel to board meeting); Other Office: AAPM&R (B per quarter for Senior Editor, PMR Journal, paid directly to institution/employer); Research Support (Investigator Salary & Staff/Materials): Scott Nadler PASSOR Musculoskeletal Research Award (C, split between Dr. Prather and staff, paid directly to institution/employer); Grants: ICTS Just In Time Core Usage Funding (B, paid to the bio-statistics department, not to Dr. Prather). JSH: Stock Ownership: Axiomed (0, 0, option for 15,000 shares); Consulting: DePuy Spine (C travel, paid directly to institution/employer); Speaking and/or teaching arrangements: Medtronic (0, no longer a consultant); Trips/Travel: Stryker (travel to resident meeting); Board of Directors: Jefferson Medical College Physician Board (Nonfinancial); Scientific Advisory Board: Axiomed (Nonfinancial, Medical advisory board), Geron (Scientific advisory board with renumeration going to TJUH research funds, paid directly to institution/employer), DePuy (resident/fellow education board, paid directly to institution/employer), CNS (Nonfinancial, Executive Board, Chair of Publication Com, Editor of CNSQ, Chair for Neurosimulation project); Other Office: Penn Neurologic Society (Nonfinancial, Board of Pennsylvania Neurosurgical Society); Research Support (Staff/Materials): NACTN (E, Spinal cord injury trial network. support for database and riluzole trial, and administrators for studies. This is part of a Department of Defense Grant, paid directly to institution/employer). JB: Nothing to disclose. JCW: Royalties: Medtronics (C), Stryker (C), Seaspine (E), Osprey (C), Aesculap (B), Biomet (F), Amedica (D), Zimmer (E), Synthes (F); Stock Ownership: Fziomed (<1%); Private Investments: Promethean Spine (B, <1%), Paradigm spine (B, <1%), Benevenue (C, <1%), NexGen (B, <1%), K2 medical (B, <1%), Pioneer (B, <1%), Amedica (D, <1%), Vertiflex (B, 1%), Electrocore (C, <1%), Surgitech (C, <1%), Axiomed (< 1%); Board of Directors: NASS (Nonfinancial, reimbursement for travel for board meetings), CSRS (Nonfinancial, reimbursement for travel for board meetings), AO Spine/AO Foundation (D, honoraria for educational activities and travel reimbursement), Collaborative Spine Research Foundation (Nonfinancial, reimbursement for travel for board meetings); Scientific Advisory Board: VG Innovations (5,000 options, < 1% of company), Corespine (2,000 options, <1% of company), Expanding Orthopaedics (33,000 options, <1% of company), Syndicom (66,125 shares, <1% of company), Osprey (10 options, <1% of company), Amedica (35,416 options, <1% of company), Bone Biologics (51,255 shares, <1% of company), Curative Biosciences (1875 options, <1% of company), Pearldiver (25,000 options, <1% of company), Pioneer (3,636 options, <1% of company), Seaspine (11 options, <1% of company). JMS: Royalties: Titan Spine (C, TLIF and PLIF cages); Stock Ownership: Titan Spine (60000 shares), Etex Corp. (15000 shares), Paradigm Spine (157500 shares); Consulting: Titan Spine (<B for past 12 months); Speaking and/or teaching arrangements: Synthes Spine (Prodisc Cervical and Lumbar surgeon teaching, B per course plus travel expenses); Scientific Advisory Board: Titan Spine (15,000 warrants (approximately) vested over 5 years. No active remuneration). JS: Nothing to disclose. KDR: Royalties: Biomet (F, C-Tek & Maxan Anterior Cervical Plate), Osprey (C, Cervical Interbody Graft Royalty), Medtronic Sofamor Danek (G, Posterior Cervical Instrumentation); Stock Ownership: Osprey (options are 1%, no ownership of company), Expanding Orthopedics (No viable products. Exact # of shares unknown), Spineology (<1% of company), Spinal Kinetics (< 1% of company), Nexgen Spine (<1% of company), Amedica (<1% of company), Vertiflex (less than 1% of company), Benvenue (<1% of company), Paradigm Spine (<1% of company), PSD (<1% of company); Board of Directors: Korean Association of Spinal Surgeons (Nonfinancial), Cervical Spine Research Society (Nonfinancial); Scientific Advisory Board: Journal of Bone and Joint Surgery (Nonfinancial), Spine Journal (Nonfinancial); Grants: Medtronic (C, IDE participation, Paid directly to institution/employer). MAL: Royalties: Orthofix (E); Consulting: Orthofix (0); Scientific Advisory Board: Orthofix (A-H of specifically defined and documented work). MHH: Royalties: Relievant Medsystems (C, My institution has licensed technology that I invented. A royalty distribution was made to my employer, the Baylor College of medicine, the legal owner of the patent. A percentage of the royalty is shared with me, as the inventor, in the amount stated, according to institutional policy, paid directly to institution/employer), K2M (C, Minimum royalty for assigned patent. I am the sole inventor of the patented IP, which was developed without commercial support. The technology was assigned to K2M four years ago. A "minimum royalty" was paid to my employer, the Baylor College of Medicine, who share some of the royalty with me, per College policy. There is no product on the market using this technology. I own no stock in K2M, and do not consult for them, paid directly to institution/employer); Stock Ownership: Relievant Medsystems (45000, 1.6% of stock ownership in this company, which is developing a minimally invasive method for the treatment of axial pain, based in my IP.); Research Support (Investigator Salary): Department of Defense (E, Salary support for research efforts is provided by peer review federal grants. This supports (offsets) my salary from my medical school, but does not result in any change in my actual pay, paid directly to institution/employer); Grants: Department of Defense (Level I, I am Principal investigator on a large grant awarded for the tissue engineering of bone for the healing of long bone fractures. The awarded funding is distributed to support multiple investigators at Baylor College of Medicine, Rice University, the University of Texas, and the University of Georgia. The work is not directly related to the spine, and has not changed my salary, paid directly to institution/employer). PAA: Royalties: Stryker (C); Stock Ownership: Pioneer (250000); Consulting: Pioneer (C), Medtronic (F); Scientific Advisory Board: SI bone (Stock option); Other: Aesculap (C). RDR: Board of Directors: NASS (reimbursement for travel/expenses on behalf of NASS. No remuneration for participating on board); Scientific Advisory Board: US FDA Scientific Advisory Panel on Orthopaedic and Rehabilitation Devices (reimbursement for travel/expenses on behalf on US FDA. Hourly rate for time spent at panel meetings @ approximately Level A/hour. Received Level A in 2010 from US FDA, and additional Level A for travel reimbursement); Other Office: AAOS (Chairman, Diversity Advisory Board. No remuneration. Travel reimbursement); Grants: US Department of Defense - Navy (G, paid directly to institution/employer), US Department of Defense – Army Medical Research Acquisition (F, paid directly to institution/employer), National Highway Traffic Safety Administration (F, paid directly to institution/employer), US Department of Education, National Institute on Disability and Rehabilitation Research (G, Paid directly to institution/employer); Other: The Spine Journal (Nonfinancial), Seminars in Spine Surgery (A). RMB: Board of Directors: ISIS (Nonfinancial, President of the International Spine Intervention Society). SEE: Board of Directors: Cervical Spine Research Society (Nonfinancial), American BoarEducation, National Institute on Disability and Rehabilitation Research (G, Paid directly to institution/employer); Other: The Spine Journal (Nonfinancial), Seminars in Spine Surgery (A). d of Orthopaedic Surgery. WCW: Royalties: Stryker Corporation (B, Royalties paid at 0.5% on Dynatrans Cervical Plate); Board of Directors: NASS (Nonfinancial), World Spine Care (Nonfinancial), American College of Spine Surgeons (Nonfinancial); Scientific Advisory Board: Intrinsic Therapeutics (Nonfinancial, Stock Options (No current value), Palladian Health (A/hour for 2 meetings/year equaling B/year); Other: The Spine Journal (Nonfinancial), Spine Arthroplasty Journal (Nonfinancial, Assistant Editor), Spine (Nonfinancial, Reviewer), Kirby Glenn Surgical Center (formerly Med Center Surgery Center) (Financial, 1/22nd minority interest ownership). WJS: Trips/Travel: Emerging Technologies Education Summit (Travel expenses and honorarium: (B (yearly 2006-2012), Maadi Military Hospital, Egypt (B, Travel expenses December 2011); Other Office: AAPM&R (Both, Reimbursement and Policy Review Committee Chair Coding and Billing Workshop Course Director (honorarium/expenses Level B), NASS (Both, RUC Advisor (travel reimbursement) Coding Committee Co-Chair (travel reimbursement/honorarium) NASS Registry Committee (none) SpineLine Editorial Committee (none). WM: Stock Ownership: Johnson & Johnson (100 shares of common stock); Private Investments: South Jersey Cyberknife (1 share, no patient referrals to center, no profit seen in 4 years); Speaking and/or teaching arrangements: NASS (B/year honoraria Speaker NASS Coding Update courses); Trips/Travel: NASS (Both, NASS Coding Update courses Level B travel expenses incurred for 2 days (coach airfare, lodging, food, tolls, mileage)- 2 meetings/year NASS CPT Advisor (B, travel expenses incurred for AMA CPT meetings-3 meetings/year); Board of Directors: NASS (Nonfinancial, Health Policy Council, Director (B, travel expenses (coach airfare, meals, tolls). WT: Stock Ownership: Phygen (Physician-owned implant company involved in development and distribution of spinal implants, paid directly to institution/employer); Other Office: Board of Managers (B, board of manager term from 2009-2010). ZG: Board of Directors: AANS - Neuropoint Alliance, CNS, Collaborative Spine Research Foundation (Nonfinancial, I serve on the Board of Directors for the Neuropoint Alliance for the AANS. I also serve on the Executive Committee for the Congress of Neurological Surgeons. I also serve on the Board of Directors for the Collaborative Spine Research Foundation. I receive no compensation for any of these positions.); Research Support (Staff/Materials): Wallace Foundation (F, Private Research Foundation, paid directly to institution/employer); Grants: NIH (C, UL1 RR024146 CTSA Grant (Yale University), paid directly to institution/employer). All author disclosures are as of 10/16/2012 during AUC project except for JMH disclosure provided 5/4/2021.

Identification

DOI: https://doi.org/10.1016/j.spinee.2021.05.023

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