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

Symptomatic Cervical Disc Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291018
• Other study ID #: PDC-08122003
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: October 17, 2017
• Start date: August 1, 2003
• Est. completion date: March 1, 2015

Study information

• Verified date: October 2017
• Source: Synthes USA HQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Diseases
• Symptomatic Cervical Disc Disease

Intervention

Device:
• Total Disc Replacement
Total Disc Replacement using ProDisc-C
• ACDF
Anterior Cervical Discectomy and Fusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synthes USA HQ, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgery Again	% of subjects who would opt to have the surgery again if given the choice at 84 months	84 Months