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

NCT ID: NCT00667459

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2014-06-30

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

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® 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.

Conditions

Cervical Degenerative Disc Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational

PRESTIGE® LP Cervical Disc

Group Type: EXPERIMENTAL

PRESTIGE® LP Cervical Disc

Intervention Type: DEVICE

The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.

Control

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

Group Type: ACTIVE_COMPARATOR

ATLANTIS Anterior Cervical Plate

Intervention Type: DEVICE

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Interventions

PRESTIGE® LP Cervical Disc

The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.

Intervention Type: DEVICE

ATLANTIS Anterior Cervical Plate

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Intervention Type: DEVICE

Other Intervention Names

PRESTIGE® LP; ATLANTIS plate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

The Hughston Clinic, P.C.

Columbus, Georgia, United States

Coeur d'Alene Spine and Brain, PLLC

Coeur d'Alene, Idaho, United States

Central Illinois Neuroscience

Bloomington, Illinois, United States

Indiana Spine

Carmel, Indiana, United States

OrthoIndy

Indianapolis, Indiana, United States

Cedar Neurological Surgeons, PC

Cedar Rapids, Iowa, United States

Sports Medicine North

Peabody, Massachusetts, United States

The Orthopaedic Center of St. Louis

Chesterfield, Missouri, United States

Springfield Neurological Institute

Springfield, Missouri, United States

Buffalo Neurosurgery Group

West Seneca, New York, United States

NeuroSpine Institute, LLC

Eugene, Oregon, United States

Clinical Trials for South Carolina

Charleston, South Carolina, United States

Chattanooga Orthopaedic Group

Chattanooga, Tennessee, United States

Brain and Spine Center of Texas, L.L.P.

Plano, Texas, United States

University of Virginia,Neurosurgery Department

Charlottesville, Virginia, United States

Countries

United States

References

Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Schranck FW, Copay AG. One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years. Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 Dec.

Reference Type: DERIVED

PMID: 31970051 (View on PubMed)

Gornet MF, Burkus JK, Shaffrey ME, Schranck FW, Copay AG. Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level. J Neurosurg Spine. 2019 May 10;31(3):317-325. doi: 10.3171/2019.2.SPINE1956. Print 2019 Sep 1.

Reference Type: DERIVED

PMID: 31075769 (View on PubMed)

Gornet MF, Burkus JK, Shaffrey ME, Nian H, Harrell FE Jr. Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes. Int J Spine Surg. 2016 Jun 22;10:24. doi: 10.14444/3024. eCollection 2016.

Reference Type: DERIVED

PMID: 27441182 (View on PubMed)

Other Identifiers

PRESTIGE® LP Protocol, #P03-03

Identifier Type: -

Identifier Source: org_study_id