An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03062657|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Degenerative Disc Disease Radiculopathy Myelopathy||Device: PRESTIGE LP™ Cervical Disc||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 6, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: PRESTIGE LP
Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
Device: 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.
- 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, standard deviation, median, minimum and maximum.
- Overall success [ Time Frame: 3, 6, and 12 months ]
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:
- NDI score improvement of at least 15 points from baseline;
- Maintenance or improvement in neurological status;
- No serious AE classified as implant associated/related or implant/surgical procedure associated/related;
- No secondary surgical procedure classified as a "failure".
- NDI success [ Time Frame: 3, 6, and 12 months ]
The self-administered Neck Disability Index (NDI) Questionnaire (Vernon and Mior, 1996) 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
- Neck pain and Arm pain [ Time Frame: 3, 6, and 12 months ]Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales.
- Neurological success [ Time Frame: 3, 6, and 12 months ]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.
- Adverse Events (AE) [ Time Frame: 3, 6, and 12 months ]An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product(s) under study. This definition includes events related to the procedures involved and/or worsening of pre-existing conditions.
- Secondary surgery at index level [ Time Frame: 3, 6, and 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062657
|United States, California|
|Todd H. Lanman, M.D., INC.||Recruiting|
|Beverly Hills, California, United States, 90210|
|Contact: Deborah Devlin 310-385-7766 firstname.lastname@example.org|
|Principal Investigator: Todd H. Lanman, MD|
|Sub-Investigator: Cuellar Jason, MD|
|United States, Michigan|
|Royal Oak, Michigan, United States, 48073|
|Contact: Lisa Motowski 248-551-6679 email@example.com|
|Principal Investigator: Jad Khalil, MD|
|Sub-Investigator: Daniel Park, MD|
|Sub-Investigator: Jeffrey Fischgrund, MD|
|United States, Oregon|
|Kellogg M.D., Brain & Spine||Recruiting|
|Portland, Oregon, United States, 97806|
|Contact: Lisa Kellogg 503-256-1462 ext 3 firstname.lastname@example.org|
|Principal Investigator: Jordi Kellogg, MD|
|United States, Pennsylvania|
|Allegheny General Hospital||Withdrawn|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, South Carolina|
|Lexington Brain and Spine||Recruiting|
|West Columbia, South Carolina, United States, 29169|
|Contact: Denise Seymour 803-935-8410 email@example.com|
|Principal Investigator: Brett Gunter, MD|