Using an osteoporotic fracture score to guide treatment for thoracic and lumbar spine fractures
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
AO Foundation, AO Spine · NCT07027306
This study will try using the OF (osteoporotic fracture) score to help doctors decide between surgery and non-surgical care for older adults with painful thoracic or lumbar osteoporotic fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 648 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | AO Foundation, AO Spine (other) |
| Locations | 15 sites (San Francisco, California and 14 other locations) |
| Trial ID | NCT07027306 on ClinicalTrials.gov |
What this trial studies
This is an international, prospective, multicenter observational study enrolling older adults with symptomatic, radiologically confirmed contiguous thoracic or lumbar (T1–L5) fractures caused by primary osteoporosis. Each eligible fracture is classified with the OF (osteoporotic fracture) system and the most severe lesion is used to calculate an OF score. Treating surgeons make an initial plan of either surgical or nonsurgical care, and patients are grouped by whether that plan agrees with the OF score recommendation (accordance) or not (discordance). The protocol defines accordance as surgical treatment when the OF score is > 6 and nonsurgical treatment when the OF score is < 6, and investigators will compare the two groups to characterize treatment patterns and outcomes.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 or older and men older than 60 with new, symptomatic, contiguous thoracic or lumbar fractures from primary osteoporosis confirmed by MRI or CT.
Not a fit: Patients with secondary causes of osteoporosis, noncontiguous or non-thoracolumbar fractures, younger patients, or those unable to attend a participating site are not likely to benefit from this protocol.
Why it matters
Potential benefit: If successful, using the OF score could lead to clearer treatment choices so more patients receive the most appropriate surgical or non-surgical care.
How similar studies have performed: Related classification systems have shown promise in retrospective or single-center reports, but large prospective multicenter validation of the OF-based decision score is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women ≥ 50 years old or men \> 60 years old o Menopause refers to amenorrhea for 1 complete year. * Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s). * In case of a multilevel fracture, the fracture must be contiguous. * The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma) * The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \[DM\], and other metabolic bone disorders \[eg, rickets/osteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\]) \[13-15\]: * A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1/3 radius * Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting. * The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5: * OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \[STIR\] sequence) * OF 2: Deformation of one endplate * OF 3: Deformation of one endplate with distinct posterior wall involvement * OF 4: Deformation of both endplates with/without posterior wall involvement * OF 5: Injuries with anterior or posterior tension band failure * Ability to provide informed consent according to the EC/IRB defined and approved procedures Exclusion Criteria: * Patients with spinal tumors * Patients with concomitant cervical fractures * Patients showing any signs of spinal infections * Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with \> 100 km/h in cars with airbags, or motor vehicle accident \> 50 km/h without airbags, polytrauma * Patients with concomitant fracture in the pelvis, upper extremities, and/or lower extremities which could affect the main study outcomes (specifically, patient mobility and pain) * Patients for whom no FUs are possible * Previous instrumented surgery in the affected spine levels * Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery * Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection * Patients who are bedridden before the index fracture * Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Where this trial is running
San Francisco, California and 14 other locations
- University of California San Francisco (USCF) Department of Orthopaedic Surgery — San Francisco, California, United States (NOT_YET_RECRUITING)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
- Sanatorio Güemes — Buenos Aires, Argentina (NOT_YET_RECRUITING)
- Cajuru University Hospital — Curitiba, Brazil (NOT_YET_RECRUITING)
- Department of Orthopedic Surgery, Clinica Alemana de Santiago — Santiago, Chile (NOT_YET_RECRUITING)
- Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine — Asyut, Egypt (NOT_YET_RECRUITING)
- Tampere University Hospital — Tampere, Finland (NOT_YET_RECRUITING)
- Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien — Erlangen, Germany (NOT_YET_RECRUITING)
- PGIMER - Postgraduate Institute of Medical Education and Research — Chandigarh, India (NOT_YET_RECRUITING)
- Dokkyo Medical University Hospital — Tochigi, Japan (NOT_YET_RECRUITING)
- Island Hospital Spine Centre — George Town, Malaysia (RECRUITING)
- Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu" — Iași, Romania (RECRUITING)
- Security Force Hospital — Riyāḑ, Saudi Arabia (RECRUITING)
- Spital Emmental - Orthopädie Sonnenhof — Burgdorf, Switzerland (NOT_YET_RECRUITING)
- King's College Hospital — London, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Klaus Schnake, MD — Center for Spinal and Scoliosis Surgery
- Study coordinator: Felix Thomas Thomas, PhD
- Email: felix.thomas@aofoundation.org
- Phone: +41 79 671 47 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporotic Fractures, Osteoporosis