Status:
COMPLETED
Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Cervical Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at...
Detailed Description
This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® ...
Eligibility Criteria
Inclusion
- Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
- One level requiring surgical treatment
- C3-C4 disc to C6-C7 disc level involvement
- Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
- No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
- Preop Neck Disability index score ≥ 30
- Preop Neck Pain score of ≥ 20 based on the Preop Neck \& Arm Pain Questionnaire
- Not pregnant at time of surgery
- Willing and able to comply with study plan and able to understand and sign patient informed consent
Exclusion
- Any other cervical spinal condition requiring surgical treatment at the involved level
- Documented or diagnosed cervical instability defined by radiographs showing
- Sagittal plane translation \> 3.5mm or
- Sagittal plane angulation \> 20 degrees.
- More than one cervical level requiring surgery
- A fused level adjacent to the level to be treated
- Severe pathology of the facet joint of involved bodies
- Previous surgery at the involved level
- Previously diagnosed osteopenia or osteomalacia
- Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
- Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
- Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
- Male over the age of 70
- Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
- If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.
- Presence of spinal metastases
- Overt or active bacterial infection, either local or systemic
- Severe insulin dependent diabetes
- Chronic or acute renal failure or history of renal disease
- Temperature \> 101º F oral at surgery
- Documented allergy to stainless steel, titanium or a titanium alloy
- Mentally incompetent
- Is a prisoner
- Is pregnant
- Is an alcohol and/or drug abuser
- Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
- A history of endocrine or metabolic disorder known to affect osteogenesis
- A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
- Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00667459
Start Date
January 1 2005
End Date
June 1 2014
Last Update
June 6 2023
Active Locations (16)
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1
Emory Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
2
The Hughston Clinic, P.C.
Columbus, Georgia, United States, 31908
3
Coeur d'Alene Spine and Brain, PLLC
Coeur d'Alene, Idaho, United States, 83814
4
Central Illinois Neuroscience
Bloomington, Illinois, United States, 61701