Clinical trial NCT00291018: Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
Official title: A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Cervical Disc Disease
Keywords: ProDisc
ProDisc-C
Spinal Fusion
Anterior cervical diskectomy
Cervical spine
Disc disease
Implant
Degenerative disc disease
Intervertebral disc
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).


Eligibility criteria: Inclusion Criteria:

* Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height.
* Age between 18 and 60 years.
* Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
* NDI score greater than or equal to 15/50 (30%).
* Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms.
* Signed informed consent.

Exclusion Criteria:

* More than one vertebral level requiring treatment.
* Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level.
* Has a fused level adjacent to the level to be treated.
* Radiographic confirmation of severe facet joint disease or degeneration.
* Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
* Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion.
* Prior surgery at the level to be treated.
* Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (\<2°).
* Neck or arm pain of unknown etiology.
* Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis).
* Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
* Severe diabetes mellitus requiring daily insulin management.
* Pregnant or interested in becoming pregnant in the next three years.
* Active infection - systemic or local.
* Taking medications 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 have been no clinical signs or symptoms of the malignancy for at least 5 years.

Primary outcomes:
measure: Overall Success
timeFrame: 84 Months
Secondary outcomes:
measure: Neurologic Success
timeFrame: 84 months
measure: NDI
timeFrame: 84 months
measure: SF-36 Physical Composite Score (PCS)
timeFrame: 84 Months
measure: SF-36 Mental Composite Score (MCS)
timeFrame: 84 Months
measure: VAS Satisfaction
timeFrame: 84 Months
measure: VAS Neck Pain Intensity
timeFrame: 84 Months
measure: VAS Neck Pain Frequency
timeFrame: 84 Months
measure: VAS Arm Pain Intensity
timeFrame: 84 Months
measure: VAS Arm Pain Frequency
timeFrame: 84 Months
measure: Surgery Again
timeFrame: 84 Months
Other outcomes:
Locations:
Study officials:
References:
citation: Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Girardi FP. Development of an expectations survey for patients undergoing cervical spine surgery. Spine (Phila Pa 1976). 2013 Apr 20;38(9):718-25. doi: 10.1097/BRS.0b013e31827bf204.
citation: Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.