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

Cervical Degenerative Disc Disease Clinical Trial

Official title:

A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667459
• Other study ID #: PRESTIGE® LP Protocol, #P03-03
• Status: Completed
• Phase: Phase 3
• Start date: January 2005
• Est. completion date: June 2014

Study information

• Verified date: May 2023
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2014
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• 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.
• ATLANTIS Anterior Cervical Plate
Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Locations

Country	Name	City	State
United States	Emory Orthopaedics and Spine Center	Atlanta	Georgia
United States	Central Illinois Neuroscience	Bloomington	Illinois
United States	Indiana Spine	Carmel	Indiana
United States	Cedar Neurological Surgeons, PC	Cedar Rapids	Iowa
United States	Clinical Trials for South Carolina	Charleston	South Carolina
United States	University of Virginia,Neurosurgery Department	Charlottesville	Virginia
United States	Chattanooga Orthopaedic Group	Chattanooga	Tennessee
United States	The Orthopaedic Center of St. Louis	Chesterfield	Missouri
United States	Coeur d'Alene Spine and Brain, PLLC	Coeur d'Alene	Idaho
United States	The Hughston Clinic, P.C.	Columbus	Georgia
United States	NeuroSpine Institute, LLC	Eugene	Oregon
United States	OrthoIndy	Indianapolis	Indiana
United States	Sports Medicine North	Peabody	Massachusetts
United States	Brain and Spine Center of Texas, L.L.P.	Plano	Texas
United States	Springfield Neurological Institute	Springfield	Missouri
United States	Buffalo Neurosurgery Group	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Overall Success	Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; Maintenance or improvement in neurological status; Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height = -2mm"; No serious adverse event classified as implant associated or implant/surgical procedure associated; and; No secondary surgical procedure classified as a "failure."	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	Operative Time	Operative time was recorded from skin incision to wound closure.	Time of operation, approximately 1.5 hrs.
Secondary	Blood Loss		During the time of operation, approximately 1.5 hours.
Secondary	Hospital Stay		During the time of hospital stay, average of 1 day.
Secondary	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.	24 months post-operation
Secondary	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.	Baseline and 24 months post-operation
Secondary	Change of Neck Pain Score From Baseline	Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.	Baseline and 24 months post-operation
Secondary	Change of Arm Pain Score From Baseline	Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.	Baseline and 24 months post-operation
Secondary	Change of General Health Status -- SF-36 PCS From Baseline	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.	Baseline and 24 months post-operation
Secondary	Change of General Health Status -- SF-36 MCS From Baseline	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.	Baseline and 24 months post-operation