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Biological Allograft Chain Tissue Implant

NCT04064710 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-05-14

No results posted yet for this study

Summary

A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.

Conditions

  • Vertebral Body Compression Fracture(s)

Interventions

PROCEDURE

Vertebral Body Augmentation

Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.

DEVICE

Manual Surgical Instruments

Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Lenoss Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2022-08-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • United States

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 NCT04064710 on ClinicalTrials.gov