Actively Recruiting
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
Led by Rigshospitalet, Denmark · Updated on 2025-04-06
240
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
C
CeraPedics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group
CONDITIONS
Official Title
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for Adult Spinal Deformity (ASD) surgery
- Indication for the use of bone graft
- Age 18 years or older at the date of surgery
You will not qualify if you...
- ASA score 4 or higher
- Diagnosed bone metabolism or wound healing disease (severe osteoporosis, osteomalacia, Paget's disease, hyperparathyroidism, etc.)
- Disseminated cancer diseases
- Hypersensitivity to any ingredients of the i-FACTOR Peptide Enhanced Bone Graft
- Smoking, extensive alcohol use, or abuse of hallucinating drugs
- Severe liver or kidney disorders
- Pregnancy or breastfeeding
- Inability to understand information sheet or no consent to participate
- Severe psychiatric diseases
- Ongoing infections
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet, Department of Orthopedics, Spine Unit
Copenhagen, Denmark
Actively Recruiting
Research Team
M
Martin Heegaard, MD, Ph.D fellow
CONTACT
M
Martin Gehrchen, MD, Ph.D, assoc. prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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