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

NCT ID: NCT03062657

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2023-01-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRESTIGE LP

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

Group Type: EXPERIMENTAL

PRESTIGE LP™ Cervical Disc

Intervention Type: 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.

Interventions

PRESTIGE LP™ Cervical Disc

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 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.);

3. 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;

4. Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels;

5. Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire;

6. Must be at least 18 years of age and be skeletally mature at the time of surgery;

7. If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;

8. Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria

A patient will be excluded from participating in this study for any of the following reasons:

1. Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;

2. Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:

1. Sagittal plane translation > 3.5 mm, or

2. Sagittal plane angulation > 20°

3. Has more than two cervical levels requiring surgical treatment;

4. Has severe pathology of the facet joints of the involved vertebral bodies;

5. Has had previous surgical intervention at either one or both of the involved levels;

6. Has been previously diagnosed with osteopenia or osteomalacia;

7. 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.):

1. . Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.

2. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.

3. Male over the age of 70.

4. 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

8. Has presence of spinal metastases;

9. Has overt or active bacterial infection, either local or systemic;

10. Has chronic or acute renal failure or prior history of renal disease;

11. Has a documented allergy or intolerance to titanium, or a titanium alloy;

12. Is mentally incompetent. (If questionable, obtain psychiatric consult);

13. Is a prisoner;

14. Is pregnant;

15. 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;

16. 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);

17. 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.);

18. 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.

19. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Beverly Hills, California, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Kellogg M.D., Brain & Spine

Portland, Oregon, United States

Lexington Brain and Spine

West Columbia, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SD1701

Identifier Type: -

Identifier Source: org_study_id