NCT02626624

Safety and Efficacy of the CarboClear Pedicle Screw System

CarboClear Pedicle Screw System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: CarboFix Orthopedics Ltd. · Industry
• Sex: All
• Age: 21 Years – 72 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature. The CarboClear Pedicle Screw System is designed for use with intervertebral body fusion device and with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, using PLIF or TLIF. A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites. Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations. Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis, Grade 1

Interventions

Type	Name	Description
DEVICE	Implantation of the CarboClear Pedicle Screw System

Timeline

• Start date: 2015-12-27
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2015-12-10
• Last updated: 2025-04-27
• Results posted: 2025-04-27

Locations

8 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study