Status:
RECRUITING
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
CeraPedics, Inc
Conditions:
Spine Deformity
Bone Graft; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cli...
Detailed Description
2\. Description and classification of medical device i-Factor Peptide Enhanced Bone graftTM: "i-FACTOR Bone Graft is a pure, natural form of hydroxyapatite (anorganic bone mineral or ABM) containing ...
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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05038527
Start Date
October 1 2021
End Date
October 1 2027
Last Update
April 6 2025
Active Locations (1)
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1
Rigshospitalet, Department of Orthopedics, Spine Unit
Copenhagen, Denmark