The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAO Foundation, AO Spine
About this trial
This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics/hospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \[MRI\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \[CT\] or MRI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Postmenopausal women ≥ 50 years old or men \> 60 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Posterior stabilization (pedicle screws)
Procedure/Surgery* Any other type of solely vertebral augmentation (stents, etc.), specify * Posterior stabilization (pedicle screws) * Posterior stabilization (pedicle screws) with kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with screw augmentation * Posterior stabilization (pedicle screws) with screw augmentation and kyphoplasty/vertebroplasty * Posterior stabilization (pedicle screws) with vertebral osteotomy (pedicle subtraction osteotomy or similar) * Combined posterior and anterior stabilization
Treatment groups
648 Participants
are divided into 2 treatment groupsGroup A: OF score accordance group1 intervention
Group B: OF score discordance group1 intervention
Trial outcomes
Primary outcomes
1
Return to mobility
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.
Time frame
From day of treatment to the end of the first 3 months after treatment.Secondary outcomes
1
Comparison of return to mobility (categorical scale)
To compare the proportion (in percentage) of patients returning to mobility level (measured in 4 categories: Not at all returned, Partially returned with major restrictions, Partially returned with minor restrictions, and Fully returned) at 3 months (short-term outcome) and 12 months (long-term outcome) between the Accordance and the Discordance group.
Time frame
At all predefined visits from discharge to 12months post treatment2
Comparison of the extent of return to mobility
To compare the extend of return (measured on a continuous scale of 0 to 100, with 0 representing no return at all and 100 representing full return) at 3 months (short-term outcome) and 12 months (long-term outcome) between the Accordance and the Discordance group.
Time frame
3 months post-operative and 12-months postoperative3
Comparison of clinical outcome
To compare the clinical outcome at 3 and 12 months between the Accordance and the Discordance groups, between patients whose initial and subsequent treatment decisions adhere to the OF score recommendations and those whose treatment decisions do not completely adhere to the OF score recommendations, between patients with symptomatic osteoporotic TL fracture treated non-surgically and those treated surgically and between nonsurgical and surgical treatments (as determined by a blinded expert group). Clinical outcome defined as any of the following events occurring: New or adjacent vertebral fracture, crossover to surgery or additional surgery, use of analgesic, fracture- or treatment-related adverse events.
Time frame
3 months post-operative and 12-months postoperative4
Comparison of the proportion return to mobility
To compare the proportion of patients returning to pre-injury mobility level at 3 and 12 months between the Accordance and the Discordance groups, between patients whose initial and subsequent treatment decisions adhere to the OF score recommendations and those whose treatment decisions do not completely adhere to the OF score recommendations, between patients with symptomatic osteoporotic TL fracture treated non-surgically and those treated surgically and between nonsurgical and surgical treatments (as determined by a blinded expert group).
Time frame
3 months post-operative and 12-months postoperativeSponsors and contacts
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Source ClinicalTrials.gov