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

Medtronic Spinal and Biologics280 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Cervical Degenerative Disc Disease

Interventions

PRESTIGE® LP Cervical DiscDEVICE

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

ATLANTIS Anterior Cervical PlateDEVICE

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

The Hughston Clinic, P.C.

Columbus, Georgia, United States

Outcomes

Primary Outcomes

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."

Time frame: 24 months

Secondary Outcomes

Success Rate of Neck Disability Index

Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.

Time frame: 24 months

Success Rate of Neurological Status

Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

Time frame: 24 months

Rate of Disc Height Success

Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \>= -2mm

Time frame: 24 months

Neck Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score \> 0.

Data from ClinicalTrials.gov

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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

...and 6 more locations

Time frame: 24 months

Arm Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0.

Time frame: 24 months

Success Rate of SF-36 PCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.

Time frame: 24 months

Success Rate of SF-36 MCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.

Time frame: 24 months

Gait Success Rate

Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \>= 0. The gait success rate is reported as the percentage of participants who had gait success.

Time frame: 24 months

Operative Time

Operative time was recorded from skin incision to wound closure.

Time frame: Time of operation, approximately 1.5 hrs.

Blood Loss

Time frame: During the time of operation, approximately 1.5 hours.

Hospital Stay

Time frame: During the time of hospital stay, average of 1 day.

Rate of Secondary Surgery at Index Level

Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.

Time frame: 24 months post-operation

Change of Neck Disability Index Score From Baseline

The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.