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NCT02626624 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the CarboClear Pedicle Screw System
A NA study of Degenerative Disc Disease and Spondylolisthesis, Grade 1, sponsored by CarboFix Orthopedics.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 8
- Study locations
NCT02626624: Completed NA study of Degenerative Disc Disease and Spondylolisthesis, Grade 1, sponsored by CarboFix Orthopedics.
NCT02626624 is a NA study of Degenerative Disc Disease and Spondylolisthesis, Grade 1 that has completed, run by CarboFix Orthopedics. The registered enrollment target is 57 participants, below the 167-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (66% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02626624, a NA study of Degenerative Disc Disease and Spondylolisthesis, Grade 1, has completed, sponsored by CarboFix Orthopedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.
Primary Outcome
Fusion was assessed at follow-up visits, starting at 6 months post operation. Fusion is defined as: 1. Angular motion ˂ 3º; AND 2. Translational motion ˂ 3 mm; AND 3. Presence of continuous bridging bone between the involved motion segment, i.e.: * Presence of interbody (between endplates) bridging bone and absence of radiolucency \> 50%; OR * Presence of right posterolateral bridging bone; OR * Presence of left posterolateral bridging bone.
Conditions Studied
Interventions
- DEVICE Implantation of the CarboClear Pedicle Screw System
Study Locations (8)
Other
- Herzliya Medical Center - Herzliya
- Meir Medical Center - Kfar Saba
- Assuta Medical Center - Israel Spine Center - Tel Aviv
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- The Brooklyn Hospital - Brooklyn
Ohio
- Crystal Clinic Orthopaedic Center - Akron
Texas
- St. David's Round Rock Medical Center - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-12-27 |
| Est. Completion | 2022-12-28 |
| Phase | NA |
What the finished NCT02626624 record still lists
NCT02626624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 167-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Implantation of the CarboClear Pedicle Screw System is the first listed.
NCT02626624 lists 8 locations in 6 states (Other, Massachusetts, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02626624 about?
NCT02626624 is a clinical study titled "Safety and Efficacy of the CarboClear Pedicle Screw System". The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lu...
What is the current status of trial NCT02626624?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2015-12-27. Estimated completion is 2022-12-28.
What conditions does trial NCT02626624 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Spondylolisthesis, Grade 1.
What interventions are being tested in trial NCT02626624?
The interventions under investigation include: Implantation of the CarboClear Pedicle Screw System (DEVICE).
Who is sponsoring clinical trial NCT02626624?
This trial is sponsored by CarboFix Orthopedics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02626624 being conducted?
This trial has 8 study locations across Massachusetts, Minnesota, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02626624's enrollment target sits among peer trials
57 28th of 42 higher than 15 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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