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Observational Study for Thoracolumbar Osteoporotic Fractures

This study is looking at how doctors decide to treat fractures in the middle and lower back (thoracolumbar) caused by weak bones (osteoporosis). It's an observational study, meaning researchers will watch and record how patients are treated in real life, rather than testing a new treatment. The study will compare patients whose treatment aligns with a special scoring system (the OF score) to those whose treatment does not. The main goal is to see how quickly patients regain their ability to move around (return to mobility) after treatment. You may be able to join if you are a postmenopausal woman over 50 or a man over 60 with a newly diagnosed fracture in your middle or lower back due to osteoporosis. The study aims to include 648 participants.

Study design
This is an international observational study involving 648 participants. Researchers will observe how doctors treat fractures and compare outcomes based on whether treatment decisions align with a specific scoring system.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the day of treatment until the end of the first three months after treatment to assess their return to mobility.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07027306

The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures

Recruiting
Not specifiedAges 50+Observational
AO Foundation, AO Spine
~648 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Posterior stabilization (pedicle screws)

At a glance

Recruiting sites
3 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Return to mobility
Measured over From day of treatment to the end of the first 3 months after treatment.

Conditions

Osteoporotic Fractures
Osteoporosis

Explore related trials

OsteoporosisThoracolumbar Fracture

Where it's being run

15 sites across 15 states
California1
Pennsylvania1
Argentina1
Brazil1
Chile1
Egypt1
Finland1
Germany1

Study leadership

  • Klaus Schnake, MD · PRINCIPAL_INVESTIGATOR · Center for Spinal and Scoliosis Surgery

Who to contact

Felix Thomas Thomas, PhD
[email protected]
+41 79 671 47 98
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal women ≥ 50 years old or men \> 60 years old
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

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

What this trial measures

  • Return to mobilityFrom day of treatment to the end of the first 3 months after treatment.

    Determination in patients with symptomatic osteoporotic TL fractures whether an initial treatment adhering to the OF score recommendations (the Accordance group) generates better short-term patient outcomes regarding time to return to mobility level before injury or symptom onset within 3 months after treatment compared to an initial treatment decision not adhering to the OF score recommendations (the Discordance group). The primary outcome of the study is return to the mobility level. Patients will be instructed to evaluate their overall mobility level in reference to their pre-injury or pre-symptom mobility status. This primary outcome will be reported by the patient and measured on a continuous scale of 0 to 100 (0 = no return at all, 100 = full return). Primary endpoint of the study is the time (days) to return of pre-injury or pre-symptom mobility level within 3 months after Day 0. Threshold of returning is defined as ≥ 80 on the continuous scale.