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NCT Number: NCT04610021

Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

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

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Key information

Conditions

Spinal Deformity Bone Graft Fusion Rate Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAULE

León, Spain

Location contact

Manuel Fernandez Gonzalez

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Owestry disability index

    Time frame: 2 years

    Disability index questionnaire

    Maximun value=100 Minimun value=0

    Patients improve when this index is arround 0

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Complejo Asistencial Universitario de León Urgencias

Other

Registry information

Official study title

Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Oct 30, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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