Prospective i-FactorTM Analysis Fusion Rate and Quality of Life (NCT04610021) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
Spain128 participantsStarted 2021-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fusion rate
Timeframe: 2 years
2
Minimal Clinically Important Difference (MCID)
Timeframe: 2 years
3
Short Form Health Survey-12 General Quality of life questionnaire
Timeframe: 2 years
4
Owestry disability index
Timeframe: 2 years
5
VISUAL ANALOGUE SCALE
Timeframe: 2 years
6
Scoliosis Research Society (SRS-22)
Timeframe: 2 years
Trial details
NCT IDNCT04610021
SponsorComplejo Asistencial Universitario de León Urgencias