Table 1

Inclusion and Exclusion Criteria for ProDisc-L (from the FDA SS&E labelling document).

Inclusion	Exclusion
Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1. Diagnosis of DDD requires back and/or leg (radicular pain); and radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (≥3mm translation or ≥5° angulation; Decreased disc height >2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon Age between 18 and 60 years Failed at least 6 months of conservative treatment Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%) (Interpreted as moderate/severe disability) Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and Signed inform consent	No more than 1 vertebral level may have DDD, and all diseased levels must be treated Patients with involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral and/or 27 mm in the anterior-posterior directions Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum Prior fusion surgery at any vertebral level Clinically compromised vertebral bodies at the affected level due to current or past trauma Radiographic confirmation of facet joint disease or degeneration Lytic spondylolisthesis or spinal stenosis Degenerative spondylolisthesis of grade > 1 Back or leg pain of unknown etiology Osteopenia or osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score < -2.5. Paget's disease, osteomalacia or anything other metabolic bone disease (excluding osteoporosis which is addressed above) Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight Pregnant or interested in becoming pregnant in the next 3 years Active infection – systemic or local Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids) Rheumatoid arthritis or other autoimmune disease Systemic disease including AIDS, HIV, Hepatitis Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years

Inclusion

Exclusion

Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1. Diagnosis of DDD requires back and/or leg (radicular pain); and radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films:
- Instability (≥3mm translation or ≥5° angulation;
- Decreased disc height >2mm;
- Scarring/thickening of annulus fibrosis;
- Herniated nucleus pulposus; or
- Vacuum phenomenon
Age between 18 and 60 years
Failed at least 6 months of conservative treatment
Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%) (Interpreted as moderate/severe disability)
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and
Signed inform consent

No more than 1 vertebral level may have DDD, and all diseased levels must be treated
Patients with involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral and/or 27 mm in the anterior-posterior directions
Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
Prior fusion surgery at any vertebral level
Clinically compromised vertebral bodies at the affected level due to current or past trauma
Radiographic confirmation of facet joint disease or degeneration
Lytic spondylolisthesis or spinal stenosis
Degenerative spondylolisthesis of grade > 1
Back or leg pain of unknown etiology
Osteopenia or osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score < -2.5.
Paget's disease, osteomalacia or anything other metabolic bone disease (excluding osteoporosis which is addressed above)
Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight
Pregnant or interested in becoming pregnant in the next 3 years
Active infection – systemic or local
Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids)
Rheumatoid arthritis or other autoimmune disease
Systemic disease including AIDS, HIV, Hepatitis
Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years