Spinal DeformityNCT04610021
Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
A study testing i-FactorTM Bone graft in people with Spinal Deformity and Bone Graft, run by Complejo Asistencial Universitario de León Urgencias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity, Bone Graft, Fusion Rate
- What is being tested?
- i-FactorTM Bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2021to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Conditions
- Spinal Deformity, Bone Graft, Fusion Rate, Quality of Life
- Being tested
- i-FactorTM Bone graft
- Keywords
- Adult Spinal deformity, Bone graft, Fusion rate, Quality of life, Spinal Surgery, Functional limitations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-FactorTM Bone graftBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group: autologous bone + bench bone |
| i-Factor | Experimental | I-Factor group: autologous bone + bench bone + i-Factor™ bone graft Receives: Biological: i-FactorTM Bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Minimal Clinically Important Difference (MCID)
Minimal clinically important difference is defined a smallest clinical change that is important to the patient.
Measured: 2 years
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.
Measured: 2 years
Owestry disability index
Disability index questionnaire
Maximun value=100 Minimun value=0
Patients improve when this index is arround 0
Measured: 2 years
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
Measured: 2 years
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- prospective randomized with intervention study.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complejo Asistencial Universitario de León Urgencias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Fernández González, Complejo Asistencial Universitario de León Urgencias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610021
- Sponsor's protocol ID
- CAULE-IFACTOR
- Status last verified
- Feb 2021
- First submitted
- 26 Oct 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity
- ClinicalTrials.gov ID
- NCT04610021
- Acronym / sponsor ID
- CAULE-IFACTOR
- Conditions
- Spinal Deformity, Bone Graft, Fusion Rate, Quality of Life
- Keywords
- Adult Spinal deformity, Bone graft, Fusion rate, Quality of life, Spinal Surgery, Functional limitations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Complejo Asistencial Universitario de León UrgenciasUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized with intervention study.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group: autologous bone + bench bone |
| i-Factor | Experimental | Biological: i-FactorTM Bone graftI-Factor group: autologous bone + bench bone + i-Factor™ bone graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-FactorTM Bone graftIn 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. | Biological | i-Factor |
Primary outcome
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.
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.
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.
Owestry disability index
Time frame: 2 years
Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-FactorTM Bone graft in people with Spinal Deformity and Bone Graft, run by Complejo Asistencial Universitario de León Urgencias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.