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Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Primary Purpose

Spinal Deformity, Bone Graft, Fusion Rate

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
i-FactorTM Bone graft
Sponsored by
Complejo Asistencial Universitario de León Urgencias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Deformity focused on measuring Adult Spinal deformity, Bone graft, Fusion rate, Quality of life, Spinal Surgery, Functional limitations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CAULE

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

i-Factor

Arm Description

Control group: autologous bone + bench bone

I-Factor group: autologous bone + bench bone + i-Factor™ bone graft

Outcomes

Primary Outcome Measures

Fusion rate
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.
Minimal Clinically Important Difference (MCID)
Minimal clinically important difference is defined a smallest clinical change that is important to the patient.
Short Form Health Survey-12 General Quality of life questionnaire
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.
Owestry disability index
Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0
VISUAL ANALOGUE SCALE
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
Scoliosis Research Society (SRS-22)
Scoliosis reseach society questionnaire 22 questions 5 options Dimensions Pain Function Selfimage Mental Health Satrisfaction Puntuation for item and test: 1(worse) - 5(better)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
February 5, 2021
Sponsor
Complejo Asistencial Universitario de León Urgencias
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1. Study Identification

Unique Protocol Identification Number
NCT04610021
Brief Title
Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
Official Title
Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Asistencial Universitario de León Urgencias

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity, Bone Graft, Fusion Rate, Quality of Life
Keywords
Adult Spinal deformity, Bone graft, Fusion rate, Quality of life, Spinal Surgery, Functional limitations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
prospective randomized with intervention study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group: autologous bone + bench bone
Arm Title
i-Factor
Arm Type
Experimental
Arm Description
I-Factor group: autologous bone + bench bone + i-Factor™ bone graft
Intervention Type
Biological
Intervention Name(s)
i-FactorTM Bone graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fusion rate
Description
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.
Time Frame
2 years
Title
Minimal Clinically Important Difference (MCID)
Description
Minimal clinically important difference is defined a smallest clinical change that is important to the patient.
Time Frame
2 years
Title
Short Form Health Survey-12 General Quality of life questionnaire
Description
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.
Time Frame
2 years
Title
Owestry disability index
Description
Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0
Time Frame
2 years
Title
VISUAL ANALOGUE SCALE
Description
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
Time Frame
2 years
Title
Scoliosis Research Society (SRS-22)
Description
Scoliosis reseach society questionnaire 22 questions 5 options Dimensions Pain Function Selfimage Mental Health Satrisfaction Puntuation for item and test: 1(worse) - 5(better)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CAULE
City
León
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Fernandez Gonzalez

12. IPD Sharing Statement

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Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

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