Comparing a new bone graft to traditional bone graft in spine surgery for adults
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial
This study tests whether a new type of bone graft can help adults with spinal surgery heal faster and have fewer problems compared to the traditional graft.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05038527 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). The study aims to determine if the new graft can lead to faster bone healing, fewer complications, and improved quality of life. It will assess the incidence of additional surgeries, patient-reported outcomes, and fusion rates post-surgery. The trial is prospective and includes patients aged 18 and older who require bone grafting for their spinal surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are indicated for surgery for Adult Spinal Deformity and require a bone graft.
Not a fit: Patients with severe bone metabolism disorders, disseminated cancer, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing spine surgery.
How similar studies have performed: Other studies have shown promising results with similar bone graft approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for ASD surgery * Indication for the use of bone graft * Age ≥ 18 years old at the date of surgery Exclusion Criteria: * ASA ≥ 4 * Formally diagnosed with a disease affecting the bone metabolism or wound healing (severe osteoporosis, osteomalacia, Pagets disease, hyperparathyreoidism etc.) * Disseminated cancer diseases * Hypersensitivity to any of the i-FACTOR Peptide Enhanced Bone Graft ingredients * Smoking, extensive alcohol use or abuse of hallucinating drugs * Severe liver or kidney disorders * Pregnancy or breastfeeding patients * Patients estimated not to be able to understand the information sheet or patients, who do not consent to participate in the study. * Severe psychiatric diseases * Ongoing infections
Where this trial is running
Copenhagen
- Rigshospitalet, Department of Orthopedics, Spine Unit — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Martin Heegaard, MD, Ph.D fellow — Rigshospitalet, Denmark
- Study coordinator: Martin Heegaard, MD, Ph.D fellow
- Email: martin.heegaard@regionh.dk
- Phone: +4529808021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.