NCT04775537

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Collagen Matrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Detailed description

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

Conditions

• Spinal Disease
• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	OssiMend™ Bioactive Moldable	Lumbar Spine fusion with OssiMend™ Bioactive Moldable

Timeline

• Start date: 2021-01-21
• Primary completion: 2026-12-30
• Completion: 2027-01-30
• First posted: 2021-03-01
• Last updated: 2025-10-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study