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

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

Inclusion Criteria3

  • Indication for ASD surgery
  • Indication for the use of bone graft
  • Age ≥ 18 years old at the date of surgery

Exclusion Criteria10

  • 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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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).


Locations(1)

Rigshospitalet, Department of Orthopedics, Spine Unit

Copenhagen, Denmark

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NCT05038527


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