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NCT05701059 · ClinicalTrials.gov registry record
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
A clinical trial of Degenerative Disc Disease and Cervical Radiculopathy, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT05701059: Recruiting study of Degenerative Disc Disease and Cervical Radiculopathy, sponsored by University of California, Los Angeles.
NCT05701059 is a study of Degenerative Disc Disease and Cervical Radiculopathy that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05701059, a study of Degenerative Disc Disease and Cervical Radiculopathy, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.
Primary Outcome
Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees. The outcome will reflect any improvement in physiological neck range of motion be patients undergoing this procedure.
Conditions Studied
Interventions
- PROCEDURE Cervical arthroplasty
- DEVICE Semi-Constrained Nuvasive Simplify
- DEVICE Unconstrained Biomet Zimmer Mobi-C
Study Locations (1)
California
- UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2026-12-01 |
What NCT05701059 shows while recruiting
NCT05701059 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (88% lower).
The record links to 4 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 3 interventions - of which Cervical arthroplasty is the first listed.
NCT05701059 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05701059 about?
NCT05701059 is a clinical study titled "Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty". This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuv...
What is the current status of trial NCT05701059?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2023-05-01. Estimated completion is 2026-12-01.
What conditions does trial NCT05701059 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spondylosis With Myelopathy, Cervical Disc Herniation.
What interventions are being tested in trial NCT05701059?
The interventions under investigation include: Cervical arthroplasty (PROCEDURE), Semi-Constrained Nuvasive Simplify (DEVICE), Unconstrained Biomet Zimmer Mobi-C (DEVICE).
Who is sponsoring clinical trial NCT05701059?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05701059 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05701059's enrollment target sits among peer trials
20 42nd of 42 higher than 1 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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