RecruitingNot ApplicableNCT05038527

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

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

Sponsor

Rigshospitalet, Denmark

Enrollment

240 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Adverse Events Spine Deformity Bone Graft; Complications

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a synthetic bone graft material (ABM/P-15, brand name i-FACTOR) to a traditional bone graft for use in adult spinal deformity (ASD) surgery, to see which results in better spinal fusion. You may be eligible if: - You are 18 years of age or older - You need surgery for adult spinal deformity - You need bone graft as part of your procedure You may NOT be eligible if: - Your surgical risk classification (ASA) is 4 or higher - You have a disease affecting bone healing (severe osteoporosis, Paget's disease, etc.) - You have metastatic (widespread) cancer - You are allergic to any component of i-FACTOR bone graft - You smoke or have heavy alcohol use or drug abuse - You have severe liver or kidney disease - You are pregnant or breastfeeding - You have a severe psychiatric illness - You have an active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEABM/P-15 bone graft

RCT (single blinded) where the patients will be randomized into two groups. One group receiving the standard bone graft which is a mix of locally autologous harvested bone and a morselized femoral head (allogenic) and the other group will receive bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15).