NCT05645497

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

Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 116 (estimated)
• Sponsor: SC Medica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.

Conditions

• Degenerative Lumbar Spinal Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2022-12-09
• Last updated: 2023-04-12

Locations

1 site across 1 country: France