ABMP-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial

Led by Rigshospitalet, Denmark · Updated on 2026-06-11

120

Participants Needed

Research Sites

N/A

Total Duration

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

Brief Title

ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery

Who Can Participate

Age: 18Years +

All Genders

Eligibility 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

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