Table 1

Contraindications to TDR Cited in Clinical Studies

Anatomical / inherent / degenerative / mechanical	Subsidence / dislocation risk
Pars defects³⁷	Osteoporosis^{7, 9, 19, 21, 25, 26, 33, 34, 36, 43, 8, 29, 30, 37, 38, 44, 49, 65, 79, 80}
Fracture at L4, L5 or S1⁹ or compromised vertebral body^{7, 16, 24, 29, 35, 38, 79, 81}	Endocrine or metabolic disorder known to affect osteogenesis³⁶
Disc height < 3mm¹⁰, <4mm⁷	Metabolic bone disease^{7, 9, 19, 21, 24, 29, 37, 43, 49, 81}
End stage disc resorption and collapse¹⁹	Osteopenia^{7, 9, 12, 16, 19, 21, 26, 31, 37, 49, 82}
Facet ankylosis⁷	Osteopathy⁷
Facet joint arthrosis/degeneration^{7–12, 14–17, 19, 21, 24–26, 29–31, 33–35, 37, 38, 41, 44, 49, 65, 78–83}	Paget disease^{7, 21}
Retrolisthesis⁷	Chronic steroid use^{9, 19, 21, 29, 37, 49, 83}
Posterior element insufficiency^{7, 21, 24, 26, 36, 43, 65}
Postsurgical deficiency of posterior elements ^{25, 31} or prior posterior lumbar surgery with significant morbidity³⁶	Pathology not, or possibly not, treatable by TDR
Scoliosis ^{7, 9, 12, 13, 16, 21, 24, 31, 33–37, 40, 49, 65, 81, 84} or major deformity^{15, 19, 25, 26, 29, 37, 38, 41, 44, 82}	Nerve root compression^{7, 16, 35}
Irregular vertebral body endplate shape^{7, 24, 29, 81}	Positive straight leg raise⁹
Spondylosis^{7, 9, 16, 21, 24, 30, 31, 35, 37, 43, 49, 65, 81, 82}	Radicular pain symptomology^{7, 15, 19, 29, 37, 43, 81, 82}
Spondylolisthesis^{7, 9, 11, 13, 15, 16, 19, 24, 29–31, 33–38, 41, 43, 44, 49, 65, 78, 80–83}	Straight leg raise producing pain below knee^{16, 35, 37}
Isthmic spondylolysis / olisthesis^{19, 21, 38}	Noncontained herniated nucleus pulposus^{7, 9, 12, 16, 19, 25, 31, 33, 34, 49, 65, 82}
Lumbosacral joint anomalies⁸¹	Scarring from previous surgery⁴³
Instability^{14, 21, 24, 37, 40, 81}	Arachnoiditis^{7, 9, 12, 19, 49}
Prior decompressive laminectomy¹²	Stenosis^{7, 9, 12, 13, 19, 21, 24, 25, 29–31, 33, 34, 36–38, 41, 43, 44, 49, 65, 78, 81, 82}
Previous fusion^{7, 9, 11, 15, 16, 19, 21, 29, 30, 33, 34, 36–38, 44, 49, 79}	Multilevel degeneration beyond 1 or 2 levels specified for TDR^{9, 19, 29, 33, 34, 36–38, 49}
Pseudoarthrosis^{7, 12, 31, 65}	Previous spinal surgery at affected level – except for discectomy, laminotomy/ectomy, without accompanying facetotomy, or intradiscal procedures at the level to be treated^{9, 13, 24, 36, 49, 81}
	Fibromyalgia⁷
Possibly reaction on implant material	Cervical myelopathy²¹
History of hypersensitivity to protein pharmaceuticals or collagen³⁶
History of implant rejection¹⁹	General
Metal allergy^{7, 9, 19, 24, 29, 30, 34, 36, 37, 44, 49, 79, 81}	Infection^{7–9, 19, 24, 26, 29, 30, 34, 36–38, 41, 43, 44, 49, 81}
History of anaphylaxis³⁶	Active hepatitis²¹
	Active malignancy^{19, 21, 29, 34, 36, 37}
Anterior approach related	3 or more Waddell signs¹³
Obesity – definition varied with study7-9^{13, 15, 16, 19, 21, 29, 30, 34, 35, 37, 44, 49}	Autoimmune disorder^{7, 9, 19, 21, 29, 34, 36, 37, 49, 83}
Vascular anatomy that is aberrant⁷	Pregnancy^{7, 19, 9, 26, 29, 30, 34, 38, 41, 44, 49, 79}
Vascular calcification⁷	Psychosocial disorder^{7, 36, 8, 9, 12, 13, 19, 37, 38, 49, 80}
Previous abdominal surgery^{7, 26, 37}	Osteomyelitis⁷
Abdominal wall hernia¹²	Spondylodiscitis⁷
Previous iliofemoral phlebitis¹²	Chronic disease of a major organ – cardiac failure, hepatitis, diabetes^{7, 26}
Abdominal pain profile¹⁹	Neuromuscular disease^{30, 44}
Previous vascular surgery⁷	Ankylosing spondylitis⁷
Prior retroperitoneal radiation^{7, 12, 19}	Spinal tumor^{7, 9, 16, 19, 24, 35, 37, 38, 41, 49, 81}
Prior surgery at the involved level^{7, 19, 36, 37, 41, 81}
	Other
	Previous exposure to any or all bone morphogenetic proteins (human or animal)³⁶