Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

NCT ID: NCT00291018

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-01
• Study Completion Date: 2015-03-01

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).

Conditions

Symptomatic Cervical Disc Disease

Keywords

ProDisc; ProDisc-C; Spinal Fusion; Anterior cervical diskectomy; Cervical spine; Disc disease; Implant; Degenerative disc disease; Intervertebral disc

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ProDisc-C

ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7

Group Type: EXPERIMENTAL

Total Disc Replacement

Intervention Type: DEVICE

Total Disc Replacement using ProDisc-C

Control

ACDF

Group Type: ACTIVE_COMPARATOR

ACDF

Intervention Type: DEVICE

Anterior Cervical Discectomy and Fusion

Interventions

Total Disc Replacement

Total Disc Replacement using ProDisc-C

Intervention Type: DEVICE

ACDF

Anterior Cervical Discectomy and Fusion

Intervention Type: DEVICE

Other Intervention Names

ProDisc-C; Control

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 23138404 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23080427 (View on PubMed)

Other Identifiers

PDC-08122003

Identifier Type: -

Identifier Source: org_study_id