- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04610021
Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
León, Spain
- CAULE
-
Contact:
- Manuel Fernandez Gonzalez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Control group: autologous bone + bench bone
|
|
Experimental: i-Factor
I-Factor group: autologous bone + bench bone + i-Factor™ bone graft
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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.
|
2 years
|
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. |
2 years
|
Owestry disability index
Time Frame: 2 years
|
Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0 |
2 years
|
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 |
2 years
|
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) |
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAULE-IFACTOR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
-
Linkoeping UniversityRecruiting
Clinical Trials on i-FactorTM Bone graft
-
Istituto Ortopedico RizzoliTerminated
-
Kuros Biosurgery AGCompletedTibia Plateau FracturesAustralia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom
-
Spine WaveTerminatedDegenerative Disc Disease | Spondylolisthesis | StenosisUnited States
-
Ain Shams UniversityActive, not recruitingImmediate Implant PlacementEgypt
-
SVS Institute of Dental SciencesAzureBio, Madrid, SoainCompleted
-
Florida Orthopaedic InstituteTerminatedFemoral Fractures | Tibial FracturesUnited States
-
Hand and Upper Limb Clinic, CanadaUnknownScaphoid Non-UnionsCanada
-
Loma Linda UniversityDentiumUSACompletedFacial Gingival ProfileUnited States
-
Nova Scotia Health AuthorityCompleted
-
Kafrelsheikh UniversityCompletedPeri-Implantitis | Alveolar Bone Loss | Dental Implant Failure NosEgypt