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

NCT05038527 | Recruiting DMC FDA Device

• 1 other identifier: ABM/P-15-RH-2021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses:

1. 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
2. 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. 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. 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. 5.The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group
6. 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

Spine Deformity; Bone Graft; Complications; Adverse Events

Keywords

Adult Spinal Deformity; Bone graft; ABM/P-15; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of revision surgery

  Incidence of revision surgery will be defined as revision surgery due to any of the following: * Implant failure (e.g rod breakage, screw breakage, cage displacement/subsidence) * Pseudarthrosis assessed by CT-scan

  2 years postoperatively

Secondary Outcomes (8)

• Patient reported outcome measures (PROMs) - VAS

  Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively

• Patient reported outcome measures (PROMs) - EQ-5D-3L

  Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively

• Patient reported outcome measures (PROMs) - Danespine Deformity Basis

  Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively

• Patient reported outcome measures (PROMs) - SRS-22

  Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively

• Bone-to-bone fusion assessed on CT scans

  1 year postoperatively

Study Arms (2)

ABM/P-15 bone graft

EXPERIMENTAL

Group A: Bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15)

Device: ABM/P-15 bone graft

Standard treatment

NO INTERVENTION

Group B: Standard bone graft which is a mix of locally harvested bone and a morselized femoral head (allogenic)

Interventions

ABM/P-15 bone graft DEVICE

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).

ABM/P-15 bone graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• CeraPedics, Inc: collaborator

Study Sites (1)

Rigshospitalet, Department of Orthopedics, Spine Unit

Copenhagen, Denmark

RECRUITING

Related Publications (52)

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Study Officials

• Martin Heegaard, MD, Ph.D fellow

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Heegaard, MD, Ph.D fellow

CONTACT

+4529808021; martin.heegaard@regionh.dk

Martin Gehrchen, MD, Ph.D, assoc. prof

CONTACT

+4529805046; poul.martin.gehrchen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student and Medical Doctor, Department of Orthopedic Surgery

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)