The impact of positive sagittal balance in adult spinal deformity.
Steven D Glassman, Keith Bridwell, John R Dimar...
https://pubmed.ncbi.nlm.nih.gov/16166889Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05038527
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial
Led by Rigshospitalet, Denmark · Updated on 2025-04-06
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
C
CeraPedics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). This study aims to improve clinical outcomes by promoting faster bone healing, reducing the need for additional surgeries, minimizing complications, and improving health-related quality of life. The trial is a prospective, randomized, controlled clinical study conducted at a specialized spine unit. Participants are randomly assigned to receive either the ABM/P-15 bone graft, which is a device combining anorganic bovine bone mineral with a synthetic peptide to enhance bone growth, or a standard bone graft made from locally harvested bone mixed with morselized allogenic femoral head. Both graft types are used during posterior spinal instrumentation and fusion surgery, with anterior support added as needed. The ABM/P-15 bone graft is placed on the spine structures and contained by the surrounding muscle. The study includes preoperative planning, surgery, and follow-up evaluations up to two years. Participants complete questionnaires before surgery and at 3 months, 1 year, and 2 years after surgery. They undergo X-rays at multiple time points and a CT scan one year after surgery to assess bone fusion and detect pseudarthrosis. Researchers track revision surgeries, adverse events, and cost-effectiveness during the study. Data on surgical details, complications, medication use, and rehabilitation are collected from medical records. The total participation lasts about two years, allowing for detailed assessment of outcomes and safety.
CONDITIONS
Brief Title
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Indication for Adult Spinal Deformity surgery
- Indication for the use of bone graft
- Age 18 years or older at the date of surgery
You will not qualify if you...
- ASA score 4 or higher
- Diagnosed disease affecting bone metabolism or wound healing (e.g., severe osteoporosis, osteomalacia, Paget's disease, hyperparathyroidism)
- Disseminated cancer diseases
- Hypersensitivity to any ingredients of the i-FACTOR Peptide Enhanced Bone Graft
- Smoking, extensive alcohol use, or abuse of hallucinating drugs
- Severe liver or kidney disorders
- Pregnancy or breastfeeding
- Unable to understand study information or refuse to consent
- Severe psychiatric diseases
- Ongoing infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits prior to surgery for eligibility assessment and information about the study
Surgery
Duration - 1 day
Participants undergo adult spinal deformity surgery where they receive either the ABM/P-15 bone graft or the standard bone graft.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 2 years
Participants attend scheduled visits for clinical assessments, radiographic imaging, and patient-reported outcome measures to monitor recovery, fusion status, adverse events, and cost-effectiveness.
Visits at approximately 7 days, 3 months, 1 year, and 2 years post-surgery including questionnaires and imaging; CT scan at 1 year post-surgery
Trial Site Locations
Total: 1 location
1
Rigshospitalet, Department of Orthopedics, Spine Unit
Copenhagen, Denmark
Actively Recruiting
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Research Team
M
Martin Heegaard, MD, Ph.D fellow
M
Martin Gehrchen, MD, Ph.D, assoc. prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Adult spine deformity.
Christopher R Good, Joshua D Auerbach, Patrick T O'Leary...
https://pubmed.ncbi.nlm.nih.gov/22021017Surgical correction of Adult Spinal Deformity in accordance to the Roussouly classification: effect on postoperative mechanical complications.
Tanvir Johanning Bari, Lars Valentin Hansen, Martin Gehrchen
https://pubmed.ncbi.nlm.nih.gov/32279244Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions.
Ferran Pellisé, Alba Vila-Casademunt, Montse Ferrer...
https://pubmed.ncbi.nlm.nih.gov/25218732Proximal junctional kyphosis and failure after spinal deformity surgery: a systematic review of the literature as a background to classification development.
Darryl Lau, Aaron J Clark, Justin K Scheer...
https://pubmed.ncbi.nlm.nih.gov/25271516Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery.
Justin S Smith, Eric Klineberg, Virginie Lafage...
https://pubmed.ncbi.nlm.nih.gov/26918574Adult spinal deformity.
Bassel G Diebo, Neil V Shah, Oheneba Boachie-Adjei...
https://pubmed.ncbi.nlm.nih.gov/31305254Morbidity and mortality of complex spine surgery: a prospective cohort study in 679 patients validating the Spine AdVerse Event Severity (SAVES) system in a European population.
Sven Karstensen, Tanvir Bari, Martin Gehrchen...
https://pubmed.ncbi.nlm.nih.gov/26456809Adult spinal deformity surgery: complications and outcomes in patients over age 60.
Michael D Daubs, Lawrence G Lenke, Gene Cheh...
https://pubmed.ncbi.nlm.nih.gov/17873817Revision Risk After Primary Adult Spinal Deformity Surgery: A Nationwide Study With Two-Year Follow-up.
Frederik T Pitter, Martin Lindberg-Larsen, Alma B Pedersen...
https://pubmed.ncbi.nlm.nih.gov/31202380