Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Medtronic

Status and phase: Completed; Phase 3

Conditions: Cervical Degenerative Disc Disease

Treatments: Device: PRESTIGE® LP Cervical Disc; Device: ATLANTIS Anterior Cervical Plate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667459

PRESTIGE® LP Protocol, #P03-03

Details and patient eligibility

About

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 a single level from C3-C4 to C6-C7.

Full 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® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Any other cervical spinal condition requiring surgical treatment at the involved level

• Documented or diagnosed cervical instability defined by radiographs showing

  1. Sagittal plane translation > 3.5mm or
  2. 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)

  1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
  2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
  3. Male over the age of 70
  4. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Investigational

Experimental group

Description:

PRESTIGE® LP Cervical Disc

Treatment:

Device: PRESTIGE® LP Cervical Disc

Control

Active Comparator group

Description:

Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876)

Treatment:

Device: ATLANTIS Anterior Cervical Plate