Cervical Degenerative Disc DiseaseNCT03062657

An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

A study testing PRESTIGE LP™ Cervical Disc in people with Cervical Degenerative Disc Disease and Radiculopathy, run by Medtronic Spinal and Biologics at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
What is being tested?: PRESTIGE LP™ Cervical Disc
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesUnited States
Study dates: 6 Jun 2018to 27 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A patient must meet all of the following inclusion criteria to participate in this study:
Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy or both;
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy;
Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels;
Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire;

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Must be at least 18 years of age and be skeletally mature at the time of surgery;
If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Who cannot join

A patient will be excluded from participating in this study for any of the following reasons:
Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Sagittal plane translation > 3.5 mm, or
Sagittal plane angulation > 20°
Has more than two cervical levels requiring surgical treatment;

Show all 27Show fewer

Has severe pathology of the facet joints of the involved vertebral bodies;
Has had previous surgical intervention at either one or both of the involved levels;
Has been previously diagnosed with osteopenia or osteomalacia;
Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility.):
. Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.
Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.
Male over the age of 70.
Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
If the level of BMD is a T score of -3.5 or lower (i.e., -3.6, -3.7, etc.) or a T score of -2.5 or lower (i.e., -2.6, -2.7 etc.) with vertebral crush fracture, then the patient is excluded from the study
Has presence of spinal metastases;
Has overt or active bacterial infection, either local or systemic;
Has chronic or acute renal failure or prior history of renal disease;
Has a documented allergy or intolerance to titanium, or a titanium alloy;
Is mentally incompetent. (If questionable, obtain psychiatric consult);
Is a prisoner;
Is pregnant;
Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
Has history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.);
Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation.
Is currently taking or has had chronic usage of certain prescription medications (e.g., Cloxacillin, an antibiotic used for prophylaxis against surgical infections, and/or Clotrimazole).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Todd H. Lanman, M.D., INC.
Beverly Hills, California, 90210
Kellogg M.D., Brain & Spine
Portland, Oregon, 97806
Beaumont Hospital
Royal Oak, Michigan, 48073
Lexington Brain and Spine
West Columbia, South Carolina, 29169

Other trials in United States

About this study

This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.

Conditions: Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
Being tested: PRESTIGE LP™ Cervical Disc
Medical subject headings: Radiculopathy, Spinal Cord Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRESTIGE LP™ Cervical DiscDevice
The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.

Study groups in NCT03062657
Study group	Role	What they receive
PRESTIGE LP	Experimental	Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. Receives: Device: PRESTIGE LP™ Cervical Disc

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation.
One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24.
Measured: Preoperative, 6 weeks, and 12 months

Secondary outcomes (5)

Number of Participants Who Achieved Overall Success
The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met:
1. NDI score improvement of at least 15 points from baseline;
2. Maintenance or improvement in neurological status;
3. No serious AE classified as implant associated/related or implant/surgical procedure associated/related;
4. No secondary surgical procedure classified as a "failure".
Measured: 3, 6, and 12 months
Number of Participants Who Achieved NDI Success
The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition:
Preoperative Score - Postoperative Score > 15
Measured: 3, 6, and 12 months
Neck Pain and Arm Pain
Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain.
Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time.
The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly.
Measured: Preoperative, 3, 6, and 12 months
Number of Participants Who Achieved Neurological Success
Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated.
Measured: 3, 6, and 12 months
Number of Participants Who Underwent Secondary Surgery at Index Level
Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed.
Measured: 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 201827 Jan 2023

First posted23 Feb 2017
Study start6 Jun 2018
Primary completion27 Jan 2023
Study completion27 Jan 2023

Why it stopped: Study terminated prematurely as agreed by the FDA. The FDA were satisfied that no further data was required, despite the total number of patients who completed the study in full not being the agreed upon number.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cervical Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03062657
Sponsor's protocol ID: SD1701
Status last verified: Apr 2024
First submitted: 20 Feb 2017
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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Assessing Microbiome in Primary Anterior Cervical Fusion Patients
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Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
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PMCF Study Fortilink-SC
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All Cervical Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
ClinicalTrials.gov ID: NCT03062657
Acronym / sponsor ID: SD1701
Conditions: Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated prematurely as agreed by the FDA. The FDA were satisfied that no further data was required, despite the total number of patients who completed the study in full not being the agreed upon number.
Enrolment: 25 participants (actual)
Lead sponsor: Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
Study start: 6 Jun 2018 (actual)
Primary completion: 27 Jan 2023 (actual)
Study completion: 27 Jan 2023 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 21 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PRESTIGE LP	Experimental	Device: PRESTIGE LP™ Cervical DiscPatients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy or both;
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy;
Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels;
Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire;

Key exclusion criteria (27 listed)

A patient will be excluded from participating in this study for any of the following reasons:
Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Has more than two cervical levels requiring surgical treatment;
Has severe pathology of the facet joints of the involved vertebral bodies;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRESTIGE LP™ Cervical DiscThe PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.	Device	PRESTIGE LP

Primary outcome

Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Time frame: Preoperative, 6 weeks, and 12 months
The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24.

5 secondary outcomes

Number of Participants Who Achieved Overall Success
Time frame: 3, 6, and 12 months
Number of Participants Who Achieved NDI Success
Time frame: 3, 6, and 12 months
Neck Pain and Arm Pain
Time frame: Preoperative, 3, 6, and 12 months
Number of Participants Who Achieved Neurological Success
Time frame: 3, 6, and 12 months
Number of Participants Who Underwent Secondary Surgery at Index Level
Time frame: 3, 6, and 12 months

Results and safety

Results posted to the registry on 21 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRESTIGE LP	25	19

Primary outcome: Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum

Time frame: Preoperative, 6 weeks, and 12 months. Mean (Standard Deviation). Unit: ng/ml

Measure	PRESTIGE LP n = 24
Titanium at Preoperative	0.2253 (0.2264)
Titanium at 6 weeks	2.7268 (1.4223)
Titanium at 12 months	4.8485 (2.6315)
Vanadium at Preoperative	0.0522 (0.1676)
Vanadium at 6 weeks	0.0508 (0.0371)
Vanadium at 12 months	0.0538 (0.0222)
Aluminum at Preoperative	1.1 (1.1)
Aluminum at 6 weeks	1.3 (1.6)

Population analysed: Due to patient drop out not all patients attended every visit

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRESTIGE LP	4 of 25 (16%)	14 of 25 (56%)	0 of 25

Limitations and caveats (from the sponsor): In agreement with the FDA, the study was terminated early, this lead to a sample size smaller than initially planned (30 planned, 25 enrolled). A short sample period was also used, however this was in agreement with the FDA based on previous evidence that the sample period would be sufficient.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cervical Degenerative Disc Disease

Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
Disc Degenerative Disease, Spine Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PRESTIGE LP™ Cervical Disc in people with Cervical Degenerative Disc Disease and Radiculopathy, run by Medtronic Spinal and Biologics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum (time frame: Preoperative, 6 weeks, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03062657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.