Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

NCT04610021 | Not Yet Recruiting DMC

• 1 other identifier: CAULE-IFACTOR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (6)

• 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.

  2 years

• Minimal Clinically Important Difference (MCID)

  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

  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

  Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0

  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

  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)

  2 years

Study Arms (2)

Control

NO INTERVENTION

Control group: autologous bone + bench bone

i-Factor

EXPERIMENTAL

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

Biological: i-FactorTM Bone graft

Interventions

i-FactorTM Bone graft BIOLOGICAL

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.

i-Factor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Complejo Asistencial Universitario de León Urgencias: lead

Study Sites (1)

CAULE

León, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jefe de Servicio

Model Details: prospective randomized with intervention study.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

ES (1)