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TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)

NCT05114135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-07-10

No results posted yet for this study

Summary

In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures. This will be an open label, prospective, first in man, single-centre clinical study to evaluate the safety and performance of Osteo3 ZP Putty synthetic bone graft in TLIF procedures with instrumented PLF. Safety and performance data obtained in this clinical study will be used to estimate clinical success rates achieved with the use of Osteo3 ZP Putty synthetic bone graft in TLIF procedures. No comparative control group is intended.

The study is expected to run for approximately three years with each subject being followed up for a two- year post-operative period. The target is to recruit approximately 17 subjects to this clinical study, allowing for some subject attrition to get 15 evaluable.

Conditions

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Lumbar Spinal Stenosis

Interventions

DEVICE

Osteo3 ZP Putty

Transforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach.

Sponsors & Collaborators

  • OssDsign

    lead INDUSTRY

Principal Investigators

  • Peter P Varga, MD · National Spine Centrer, Buda Health Center, Budapest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2023-04-20
Completion
2024-03-14

Countries

  • Hungary

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 NCT05114135 on ClinicalTrials.gov