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

NCT00667459 | Completed Phase 3 Results DMC

• 1 other identifier: PRESTIGE® LP Protocol, #P03-03
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 16

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.

Conditions

Cervical Degenerative Disc Disease

Keywords

Cervical Disc

Outcome Measures

Primary Outcomes (1)

• Rate of Overall Success

  Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; 2. Maintenance or improvement in neurological status; 3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm"; 4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 5. No secondary surgical procedure classified as a "failure."

  24 months

Secondary Outcomes (17)

• Success Rate of Neck Disability Index

  24 months

• Success Rate of Neurological Status

  24 months

• Rate of Disc Height Success

  24 months

• Neck Pain Success Rate

  24 months

• Arm Pain Success Rate

  24 months

Study Arms (2)

Investigational

EXPERIMENTAL

PRESTIGE® LP Cervical Disc

Device: PRESTIGE® LP Cervical Disc

Control

ACTIVE COMPARATOR

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

Device: ATLANTIS Anterior Cervical Plate

Interventions

PRESTIGE® LP Cervical Disc DEVICE

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

Also known as: PRESTIGE® LP

Investigational

ATLANTIS Anterior Cervical Plate DEVICE

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Also known as: ATLANTIS plate

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (16)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

The Hughston Clinic, P.C.

Columbus, Georgia, 31908, United States

Location

Coeur d'Alene Spine and Brain, PLLC

Coeur d'Alene, Idaho, 83814, United States

Location

Central Illinois Neuroscience

Bloomington, Illinois, 61701, United States

Location

Indiana Spine

Carmel, Indiana, 46032, United States

Location

OrthoIndy

Indianapolis, Indiana, 46260, United States

Location

Cedar Neurological Surgeons, PC

Cedar Rapids, Iowa, 52403, United States

Location

Sports Medicine North

Peabody, Massachusetts, 01960, United States

Location

The Orthopaedic Center of St. Louis

Chesterfield, Missouri, 63017, United States

Location

Springfield Neurological Institute

Springfield, Missouri, 65804, United States

Location

Buffalo Neurosurgery Group

West Seneca, New York, 14224, United States

Location

NeuroSpine Institute, LLC

Eugene, Oregon, 97401, United States

Location

Clinical Trials for South Carolina

Charleston, South Carolina, 29406, United States

Location

Chattanooga Orthopaedic Group

Chattanooga, Tennessee, 37404, United States

Location

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

Plano, Texas, 75093, United States

Location

University of Virginia,Neurosurgery Department

Charlottesville, Virginia, 22908, United States

Location

Related Publications (3)

• 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.

  PMID: 31970051 DERIVED

• 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.

  PMID: 31075769 DERIVED

• 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.

  PMID: 27441182 DERIVED

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: January 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2014
• Last Updated: June 6, 2023
• Results First Posted: September 22, 2014

Record last verified: 2023-05

Locations

US (16)