NCT00291018

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 8, 2017

Completed
Last Updated

November 20, 2017

Status Verified

October 1, 2017

Enrollment Period

11.6 years

First QC Date

February 10, 2006

Results QC Date

November 17, 2016

Last Update Submit

October 17, 2017

Conditions

Symptomatic Cervical Disc Disease

Keywords

ProDiscProDisc-CSpinal FusionAnterior cervical diskectomyCervical spineDisc diseaseImplantDegenerative disc diseaseIntervertebral disc

Outcome Measures

Primary Outcomes (1)

  • Overall Success

    Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material

    84 Months

Secondary Outcomes (10)

  • Neurologic Success

    84 months

  • NDI

    84 months

  • SF-36 Physical Composite Score (PCS)

    84 Months

  • SF-36 Mental Composite Score (MCS)

    84 Months

  • VAS Satisfaction

    84 Months

  • +5 more secondary outcomes

Study Arms (2)

ProDisc-C

EXPERIMENTAL

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

Device: Total Disc Replacement

Control

ACTIVE COMPARATOR

ACDF

Device: ACDF

Interventions

Total Disc ReplacementDEVICE

Total Disc Replacement using ProDisc-C

Also known as: ProDisc-C
ProDisc-C
ACDFDEVICE

Anterior Cervical Discectomy and Fusion

Also known as: Control
Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23138404DERIVED

  • 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.

    PMID: 23080427DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Results Point of Contact

Title
Erin Prifogle
Organization
DePuy Synthes Spine
eprifog1@its.jnj.com
508-977-6451

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

August 1, 2003

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 20, 2017

Results First Posted

March 8, 2017

Record last verified: 2017-10