Clinical trial NCT04610021: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Complejo Asistencial Universitario de León Urgencias
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective randomized with intervention study.
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: Fusion rate
timeFrame: 2 years
measure: Minimal Clinically Important Difference (MCID)
timeFrame: 2 years
measure: Short Form Health Survey-12 General Quality of life questionnaire
timeFrame: 2 years
measure: Owestry disability index
timeFrame: 2 years
measure: VISUAL ANALOGUE SCALE
timeFrame: 2 years
measure: Scoliosis Research Society (SRS-22)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: León
country: Spain
facility: CAULE
Study officials:
References: