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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Indication for ASD surgery

• Indication for the use of bone graft

• Age ≥ 18 years old at the date of surgery

Locations
Other Locations
Denmark
Rigshospitalet, Department of Orthopedics, Spine Unit
RECRUITING
Copenhagen
Contact Information
Primary
Martin Heegaard, MD, Ph.D fellow
martin.heegaard@regionh.dk
+4529808021
Backup
Martin Gehrchen, MD, Ph.D, assoc. prof
poul.martin.gehrchen@regionh.dk
+4529805046
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 240
Treatments
Experimental: ABM/P-15 bone graft
Group A: Bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15)
No_intervention: Standard treatment
Group B: Standard bone graft which is a mix of locally harvested bone and a morselized femoral head (allogenic)
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: CeraPedics, Inc

This content was sourced from clinicaltrials.gov

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