Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

February 5, 2021 updated by: Manuel Fernández González, Complejo Asistencial Universitario de León Urgencias

Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity

Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery.

Autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options.

I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles.

In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • León, Spain
        • CAULE
        • Contact:
          • Manuel Fernandez Gonzalez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of legal age.
  • Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.
  • Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).
  • Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.
  • The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.

Exclusion Criteria:

  • Patients who are expected to be unavailable for follow-up.
  • Patients with mental disabilities that make it difficult for them to fill in the questionnaires.
  • Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.
  • Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.
  • Underlying neurological or neuromuscular disease.
  • Underlying inflammatory or tumor disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group: autologous bone + bench bone
Experimental: i-Factor
I-Factor group: autologous bone + bench bone + i-Factor™ bone graft
In the i-Factor ™ group it will be placed longitudinally in the intertransverse area. Likewise, in both groups, only autologous and bench bone will be placed in the intersomatic cages. The vertebrae where the i-Factor ™ is placed will be noted on the data collection sheet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion rate
Time Frame: 2 years
The success of the fusion at 12 and 24 months will be determined by a specialized radiologist by the evidence in the CT scan of trabecular bone bridges between the inter-transverse areas of the vertebral bodies and the absence of radiolucency adjacent to the implants.
2 years
Minimal Clinically Important Difference (MCID)
Time Frame: 2 years
Minimal clinically important difference is defined a smallest clinical change that is important to the patient.
2 years
Short Form Health Survey-12 General Quality of life questionnaire
Time Frame: 2 years

The questions that follow ask what you think about your health. Your answers will allow you to know how you are and to what extent you are able to do your usual activities.

Patients improve when the puntuation is more than 50.

2 years
Owestry disability index
Time Frame: 2 years

Disability index questionnaire

Maximun value=100 Minimun value=0

Patients improve when this index is arround 0

2 years
VISUAL ANALOGUE SCALE
Time Frame: 2 years

Is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.

Maximun value=10 Minimun value=0

Patients improve when this index is arround 0

2 years
Scoliosis Research Society (SRS-22)
Time Frame: 2 years

Scoliosis reseach society questionnaire

22 questions 5 options Dimensions Pain Function Selfimage Mental Health Satrisfaction

Puntuation for item and test: 1(worse) - 5(better)

2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAULE-IFACTOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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