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

NCT03407560 | Completed

• 1 other identifier: CVOD.SintLife
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bone substitute; spinal fusion; lumbar spine disease

Outcome Measures

Primary Outcomes (1)

• Spinal fusion

  Brantigan fusion score to evaluate 5 levels of fusion

  18 months

Secondary Outcomes (4)

• Back pain assessed by VAS (Visual Analog Scale)

  Change from baseline at 6, 12, 18 months

• Functional activity assessed by ODI (Oswestry Disability Index)

  Change from baseline at 6, 12, 18 months

• Quality of life assessed by EQ-5D (Euro-QoL5D)

  Change from baseline at 6, 12, 18 months

• Adverse events

  18 months

Study Arms (1)

SintLife

EXPERIMENTAL

Use of SintLife putty as bone substitute for spinal fusion in lumbar spine surgery for degenerative diseases.

Device: SintLife

Interventions

SintLife DEVICE

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.

SintLife

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have provided consent to the processing of personal data;
• Patients over the age of 18;
• Patients who require posterolateral fusion of lumbosacral tract (L1- S1);
• Patients suffering from traumatic and degenerative diseases of the spine, such as lumbar stenosis, spondylolysis and spondylolisthesis, degenerative disc disease;
• Patients who agree to participate in the program of visits required by the Protocol.

You may not qualify if:

• Patients affected by:
• systemic or localized infection
• inflammatory or autoimmune disease
• hypercalcemia
• coagulation disorders
• metabolic disorders
• insulin dependent diabetes
• alterations or complications of thyroid function
• allergy to calcium phosphate
• declared allergies to medications and / or medical device
• tumor diseases and / or infectious diseases of the spine
• active neoplasia
• Patients who abuse of alcohol or drugs
• Patients in the alleged pregnancy or confirmed
• Patients on medication that causes abnormal bone regeneration (eg chemotherapy)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (26)

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MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Giovanni Barbanti Brodano, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: March 31, 2017
• Primary Completion: September 19, 2019
• Study Completion: March 31, 2021
• Last Updated: May 11, 2023

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)