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

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)

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).

Study Overview

• Status: Completed
• Conditions: Symptomatic Cervical Disc Disease
• Intervention / Treatment: Device: Total Disc Replacement; Device: ACDF

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProDisc-C; ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7	Device: Total Disc Replacement; Total Disc Replacement using ProDisc-C; Other Names: ProDisc-C
Active Comparator: Control; ACDF	Device: ACDF; Anterior Cervical Discectomy and Fusion; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic Success	% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)	84 months
NDI	NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation. Mean duration of the test is 3-8 minutes and the results can be interpreted as: 0-4 points (0-8%) no disability;; 5-14 points (10-28%) mild disability;; 15-24 points (30-48%) moderate disability;; 25-34 points (50-64%) severe disability;; 35-50 points (70-100%) complete disability	84 months
SF-36 Physical Composite Score (PCS)	The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions.	84 Months
SF-36 Mental Composite Score (MCS)	The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions.	84 Months
VAS Satisfaction	The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction [with the surgery/outcome]" at 0mm and "Complete Satisfaction [with the surgery/outcome]" at 100mm.	84 Months
VAS Neck Pain Intensity	The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Neck] Pain" at 0mm and "Worst [Neck] Pain Possible" at 100mm.	84 Months
VAS Neck Pain Frequency	The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Neck] Pain" at 0mm and "All of the Time [Neck] Pain" at 100mm.	84 Months
VAS Arm Pain Intensity	The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Arm] Pain" at 0mm and "Worst [Arm] Pain Possible" at 100mm.	84 Months
VAS Arm Pain Frequency	The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Arm] Pain" at 0mm and "All of the Time [Arm] Pain" at 100mm.	84 Months
Surgery Again	% of subjects who would opt to have the surgery again if given the choice at 84 months	84 Months

Collaborators and Investigators

• Sponsor: Synthes USA HQ, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2003
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 10, 2006
• First Submitted That Met QC Criteria: February 10, 2006
• First Posted (Estimate): February 13, 2006

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Degenerative disc disease; Implant; Spinal Fusion; Cervical spine; Intervertebral disc; ProDisc; ProDisc-C; Anterior cervical diskectomy; Disc disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: PDC-08122003