Using an osteoporotic fracture score to guide treatment for thoracic and lumbar spine fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.