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Evaluation of the Efficacy and Safety of the FACET FIXation Implant.

NCT05645497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 116

Last updated 2023-04-12

No results posted yet for this study

Summary

This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.

The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.

Conditions

  • Degenerative Lumbar Spinal Stenosis

Interventions

PROCEDURE

Surgery with FACET FIXATION implants

Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants

PROCEDURE

Surgery with Pedicle Screw

Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw

Sponsors & Collaborators

  • SC Medica

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645497 on ClinicalTrials.gov