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

NCT03062657 | Terminated Results DMC FDA Device

• 1 other identifier: SD1701
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative, 6 weeks, and 12 months

Secondary Outcomes (5)

• Number of Participants Who Achieved Overall Success

  3, 6, and 12 months

• Number of Participants Who Achieved NDI Success

  3, 6, and 12 months

• Neck Pain and Arm Pain

  Preoperative, 3, 6, and 12 months

• Number of Participants Who Achieved Neurological Success

  3, 6, and 12 months

• Number of Participants Who Underwent Secondary Surgery at Index Level

  3, 6, and 12 months

Study Arms (1)

PRESTIGE LP

EXPERIMENTAL

Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.

Device: PRESTIGE LP™ Cervical Disc

Interventions

PRESTIGE LP™ Cervical Disc DEVICE

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.

PRESTIGE LP

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 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;
• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (4)

Todd H. Lanman, M.D., INC.

Beverly Hills, California, 90210, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Kellogg M.D., Brain & Spine

Portland, Oregon, 97806, United States

Location

Lexington Brain and Spine

West Columbia, South Carolina, 29169, United States

Location

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Central Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Rhys Jones, PhD; Senior Clinical Research Specialist
• Organization: Medtronic

rhys.j.jones@medtronic.com

+44 7826874430

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: June 6, 2018
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: April 5, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-04

Locations

US (4)