MedTrace Logo

Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.

NCT03407560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-05-11

No results posted yet for this study

Summary

This pilot study is to evaluate the potential effectiveness of bone substitute SintLife within the spinal surgery in spinal stabilization applications for degenerative diseases.

In particular, the investigators propose to evaluate:

* the ability of bone regeneration/ fusion, defined as the presence of trabecular bone continuous bridge and absence of radiolucent lines, verified by diagnostic imaging in accordance with the Brantigan scale;
* the patient's state of health, evaluated through the comparison of the functional-symptom pattern between the pre- and post-operative phases, verified by Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and EuroQol (EQ-5D);
* the safety of the medical device, evaluated through the impact of any adverse events, complications, unexpected reactions, accidents.

STUDY DESIGN This collection of clinical data is set up as pilot study post-marketing. In the study will be included all consecutive patients who require spinal fusion surgery, in accordance with the inclusion and exclusion criteria after signing the informed consent. Patients will be treated and followed postoperatively according to the normal clinical, surgical and therapeutic practice, in place at the Rizzoli Orthopaedic Institute of Bologna.

The total duration of data collection is 36 months:

* the stage of patient enrollment is 18 months from the date of approval of the study by the Ethics Committee of the center;
* the phase of post-operative monitoring is 18 months, with planned at 6, 12 and 18 months follow-up (± 15 days before scheduled date).

Conditions

  • Spinal Fusion

Interventions

DEVICE

SintLife

Patients will be treated for degenerative diseases of the spine, such as lumbar stenosis, spondylolysis and spondylolisthesis, degenerative disc disease. The fusion technique used will be the posterolateral arthrodesis of one or more vertebral levels included in the lumbosacral region (L1-S1), obtained by screws and bars, together with a preparation of the transverse processes treated with bone substitute in order to Sintlife obtain new bone formation and then spinal fusion. It is also possible to associate interbody fusion with the use of a cage.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Giovanni Barbanti Brodano, MD · Istituto Ortopedico Rizzoli

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2019-09-19
Completion
2021-03-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03407560 on ClinicalTrials.gov