Osteoporotic FracturesNCT07027306
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
An observational study of Osteoporotic Fractures and Osteoporosis, run by AO Foundation, AO Spine at 15 sites in 14 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures, Osteoporosis
- What is being tested?
- Posterior stabilization (pedicle screws)
- Type of treatment
- Surgery or procedure
- How many people
- 648 participants
- Where
- 15 sitesin 14 countries
- Study dates
- 19 Mar 2026to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women ≥ 50 years old or men > 60 years old
Who may be able to join
- 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]:
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 14 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107-4216
Alexander R Vaccaro, MD, alex.vaccaro@rothmaninstitute.com
- Not yet recruiting
University of California San Francisco (USCF) Department of Orthopaedic Surgery
San Francisco, California, 94143-0728
Ashraf El Naga, MD, ashraf.elnaga@ucsf.edu
Argentina1 site, 1 recruiting
- Not yet recruiting
Sanatorio Güemes
Buenos Aires, 1240
Guillermo Ricciardi, MD, guillermoricciardi@gmail.com
Brazil1 site, 1 recruiting
- Not yet recruiting
Cajuru University Hospital
Curitiba, 80050-50
Emiliano Vialle, MD, evialle@hotmail.com
Chile1 site, 1 recruiting
- Not yet recruiting
Department of Orthopedic Surgery, Clinica Alemana de Santiago
Santiago, 5951
Ratko Yurac, MD, ryurac@gmail.com
Egypt1 site, 1 recruiting
- Not yet recruiting
Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine
Asyut, 71526
Mohammad El-Sharkawi, MD, sharkoran@aun.edu.eg
Finland1 site, 1 recruiting
- Not yet recruiting
Tampere University Hospital
Tampere, 33521
Marko Neva, MD, marko_neva@yahoo.com
Germany1 site, 1 recruiting
- Not yet recruiting
Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien
Erlangen, 91054
Klaus Schnake, MD, Klaus.Schnake@waldkrankenhaus.de
India1 site, 1 recruiting
- Not yet recruiting
PGIMER - Postgraduate Institute of Medical Education and Research
Chandigarh, 160 012
Vishal Kumar, MD, drkumarvishal@gmail.com
Japan1 site, 1 recruiting
- Not yet recruiting
Dokkyo Medical University Hospital
Tochigi, 321-0293
Masahito Takahata, MD, takahiroshm@yahoo.co.jp
Malaysia1 site, 1 recruiting
- Recruiting
Island Hospital Spine Centre
George Town, 10450
Kim Soon Oh, MD, ohkimsoon@utar.edu.my
Romania1 site, 1 recruiting
- Recruiting
Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu"
Iași, 700309
Eugen Cezar Popescu, MD, ciepopescu@yahoo.com
Saudi Arabia1 site, 1 recruiting
- Recruiting
Security Force Hospital
Riyāḑ, 11564
Ahmed Alzahrani, MD, ahmed_alzahrani_4@hotmail.com
Switzerland1 site, 1 recruiting
- Not yet recruiting
Spital Emmental - Orthopädie Sonnenhof
Burgdorf, 3400
Sebastian Bigdon, MD, sebastian.bigdon@insel.ch
United Kingdom1 site, 1 recruiting
- Not yet recruiting
King's College Hospital
London, SE5 9RS
Gordan Grahovac, MD, gordan.grahovac@nhs.net
About this study
Official title: The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
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).
Read the detailed description
This is an international multicenter prospective observational study. Postmenopausal women ≥ 50 years old and men > 60 years old 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).
All osteoporotic TL fractures will be classified using the OF classification system (OF 1 to OF 5). Only the most severe fracture will be used to calculate the OF score. The OF score will be subsequently calculated to aid the surgeons' decision making on the initial treatment plan, which is categorized as either nonsurgical or surgical treatment.
To address the primary study objective, depending on whether the treating surgeons' eventual initial treatment decisions agree with the OF score recommendations, patients will be divided into two groups: 1) patients whose initial treatment is in accordance with the OF score recommendations (the Accordance group), and 2) patients whose initial treatment is in discordance with the OF score recommendations (the Discordance group). Accordance refers to 1) when the OF score is > 6, surgical treatment is prescribed by the treating surgeons, 2) when the OF score is < 6, nonsurgical treatment only is prescribed by the treating surgeons, and 3) when the OF score is 6, either surgical or nonsurgical treatment is prescribed (Note: any surgeons' decision is deemed in accordance with the OF score as the system leaves the decision to the surgeons' discretion in this situation).
Accordance/Discordance group assignment is based on the agreement/discrepancy between the eventual treatment and the recommendations from the OF score that is obtained up to Day 0, although OF scores may be calculated at follow-ups (FUs) for subsequent treatment decision making (eg, whether the treatment plan needs to be modified).
Depending on the actual initial treatment assigned to the patients by the treating surgeons, patients will be divided into two groups: 1) patients assigned to receive nonsurgical treatment (the Nonsurgical group), and 2) patients assigned to receive surgery (the Surgical group).
Day 0 refers to the day when the initial treatment is decided and starts (categorized as nonsurgical or surgical treatment). Subsequent FUs will be calculated in reference to Day 0. Patients will be followed up clinically at discharge, 6 weeks, 3 months, 6 months, and 12 months.
The primary outcome of the study is the return to the mobility level before the injury or symptom onset (as reported by the patient). The FU period for the primary endpoint of the study is 3 months (short-term), and 12 months for the secondary endpoints (long-term).
- Conditions
- Osteoporotic Fractures, Osteoporosis
- Being tested
- Posterior stabilization (pedicle screws)
- Medical subject headings
- Osteoporotic Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior stabilization (pedicle screws)Procedure or surgery
Also called Kyphoplasty, Vertebroplasty
- 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
| Study group | Role | What they receive |
|---|---|---|
| OF score accordance group | Initial treatment decision in accordance with the OF score recommendations Receives: Procedure: Posterior stabilization (pedicle screws) | |
| OF score discordance group | Initial treatment decision in discordance with the OF score recommendations Receives: Procedure: Posterior stabilization (pedicle screws) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of treatment to the end of the first 3 months after treatment.
Secondary outcomes (19)
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.
Measured: At all predefined visits from discharge to 12months post treatment
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.
Measured: 3 months post-operative and 12-months postoperative
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.
Measured: 3 months post-operative and 12-months postoperative
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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of Timed Up & Go test
To compare timed Up \& Go in seconds 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of daily activities
To compare the score of the Barthel Index (ranging from 0 to 100, with higher scores indicating greater functional independence) 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of pain NRS (Numeric Rate Scale)
To compare the score of pain Numeric Rate Scale (ranging from 0 to 10, with 0 representing no pain and 10 the worst imaginable pain) 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of ODI (Oswestry Disability Index)
To compare the score of ODI (ranging from 0 to 100%, with higher scores indicating greater disability) 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of quality of live
To compare the score of EQ-5D-5L (ranging from 0 to 1, with 0 representing death and 1 perfect health) 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of the AO Spine PROST
To compare the score of AO Spine PROST (ranging from 0 to 100, with higher score indicating better recovery of functional level before trauma) 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).
Measured: 3 months post-operative and 12-months postoperative
Comparison of the overall satisfaction
To compare the proportion of overall satisfaction (measured on a 7-point Likert scale (Extremely satisfied, Very satisfied, Somewhat satisfied, Mixed, Somewhat dissatisfied, Very dissatisfied, Extremely dissatisfied) of patients 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).
Measured: 3 months post-operative and 12-months postoperative
Complications-determination in relation to surgery
To determine the rate and type of complications in relation to the type of surgery performed
Measured: 1 year post-operative
Complications-determination in relation to OF subtype
To determine the rate and type of complications in relation to the OF subtype
Measured: 1 year post-operative
Determination of type of treatment
To determine the type of treatment in relation to the OF subtype
Measured: 1 year post-operative
Determination of rate and type of surgical treatment
To determine the type of surgical treatment in relation to the OF subtype. The surgery types are:
- Kyphoplasty
- Vertebroplasty
- 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, if yes:
- Open surgery
- Percutaneous/minimal-invasive surgery
- Delete "rate" from 10 only keeping type and list them from above
Measured: 1 year post-operative
Proportion between surgery after initial non-surgery treatment
To determine the proportion of patients who underwent surgery after initial nonsurgical treatment (crossover to surgery).
Measured: 1 year post-operative
Agreement between OF classification and investigators
To determine the proportion of agreement in the OF classification (from OF 1 to OF 5 categories) made by the site investigators and a blinded expert panel.
OF 1: No deformation (vertebral body edema in MRI-STIR) OF 2: Deformation of one endplate without or with only minor posterior wall involvement OF 3: Deformation of one endplate with distinct posterior wall involvement OF 4: Deformation of both endplates with or without posterior wall involvement OF 5: Injuries with anterior or posterior tension band failure
Measured: 1 year post-operative
Validation of AO PROST
To validate the AO Spine Patient-Reported Outcome Spine Trauma (PROST) in terms of interpretability, internal consistency, and responsiveness in patients with symptomatic osteoporotic TL fractures.
The AO Spine PROST consists of 19 questions on broad aspects of functioning. Each item has a 0-100 scale, with 0 indicating no function at all and 100 the functional level before trauma. Total score ranges from 0 to 100, with higher score indicating better recovery of functional level before trauma.
Measured: 1 year post-operative
Health economic analyses
To perform health economic analyses to investigate the cost-effectiveness/cost-utility of a) comparing non-surgical to surgical treatment and b) the effect of adhering to the OF score for treating patients with osteoporotic TL fractures compared with not adhering to the OF score.
The cost-effectiveness will be evaluated using the incremental cost effectiveness ratio.
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start19 Mar 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus Schnake, MD, Principal investigator, Center for Spinal and Scoliosis Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027306
- Sponsor's protocol ID
- TL-OF
- Status last verified
- May 2026
- First submitted
- 2 May 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07027306
- Acronym / sponsor ID
- TL-OF
- Conditions
- Osteoporotic Fractures, Osteoporosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is an international multicenter prospective observational study. Postmenopausal women ≥ 50 years old and men > 60 years old 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).
All osteoporotic TL fractures will be classified using the OF classification system (OF 1 to OF 5). Only the most severe fracture will be used to calculate the OF score. The OF score will be subsequently calculated to aid the surgeons' decision making on the initial treatment plan, which is categorized as either nonsurgical or surgical treatment.
To address the primary study objective, depending on whether the treating surgeons' eventual initial treatment decisions agree with the OF score recommendations, patients will be divided into two groups: 1) patients whose initial treatment is in accordance with the OF score recommendations (the Accordance group), and 2) patients whose initial treatment is in discordance with the OF score recommendations (the Discordance group). Accordance refers to 1) when the OF score is > 6, surgical treatment is prescribed by the treating surgeons, 2) when the OF score is < 6, nonsurgical treatment only is prescribed by the treating surgeons, and 3) when the OF score is 6, either surgical or nonsurgical treatment is prescribed (Note: any surgeons' decision is deemed in accordance with the OF score as the system leaves the decision to the surgeons' discretion in this situation).
Accordance/Discordance group assignment is based on the agreement/discrepancy between the eventual treatment and the recommendations from the OF score that is obtained up to Day 0, although OF scores may be calculated at follow-ups (FUs) for subsequent treatment decision making (eg, whether the treatment plan needs to be modified).
Depending on the actual initial treatment assigned to the patients by the treating surgeons, patients will be divided into two groups: 1) patients assigned to receive nonsurgical treatment (the Nonsurgical group), and 2) patients assigned to receive surgery (the Surgical group).
Day 0 refers to the day when the initial treatment is decided and starts (categorized as nonsurgical or surgical treatment). Subsequent FUs will be calculated in reference to Day 0. Patients will be followed up clinically at discharge, 6 weeks, 3 months, 6 months, and 12 months.
The primary outcome of the study is the return to the mobility level before the injury or symptom onset (as reported by the patient). The FU period for the primary endpoint of the study is 3 months (short-term), and 12 months for the secondary endpoints (long-term).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OF score accordance group | – | Procedure: Posterior stabilization (pedicle screws)Initial treatment decision in accordance with the OF score recommendations |
| OF score discordance group | – | Procedure: Posterior stabilization (pedicle screws)Initial treatment decision in discordance with the OF score recommendations |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women ≥ 50 years old or men > 60 years old
Key inclusion criteria (15 listed)
- 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).
- 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]:
- The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior stabilization (pedicle screws)Also: Kyphoplasty, Vertebroplasty* 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 | Procedure or surgery | OF score accordance group, OF score discordance group |
Primary outcome
Return to mobility
Time frame: From 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.
19 secondary outcomes
Comparison of return to mobility (categorical scale)
Time frame: At all predefined visits from discharge to 12months post treatment
Comparison of the extent of return to mobility
Time frame: 3 months post-operative and 12-months postoperative
Comparison of clinical outcome
Time frame: 3 months post-operative and 12-months postoperative
Comparison of the proportion return to mobility
Time frame: 3 months post-operative and 12-months postoperative
Comparison of Timed Up & Go test
Time frame: 3 months post-operative and 12-months postoperative
Comparison of daily activities
Time frame: 3 months post-operative and 12-months postoperative
Comparison of pain NRS (Numeric Rate Scale)
Time frame: 3 months post-operative and 12-months postoperative
Comparison of ODI (Oswestry Disability Index)
Time frame: 3 months post-operative and 12-months postoperative
Comparison of quality of live
Time frame: 3 months post-operative and 12-months postoperative
Comparison of the AO Spine PROST
Time frame: 3 months post-operative and 12-months postoperative
Comparison of the overall satisfaction
Time frame: 3 months post-operative and 12-months postoperative
Complications-determination in relation to surgery
Time frame: 1 year post-operative
Complications-determination in relation to OF subtype
Time frame: 1 year post-operative
Determination of type of treatment
Time frame: 1 year post-operative
Determination of rate and type of surgical treatment
Time frame: 1 year post-operative
Proportion between surgery after initial non-surgery treatment
Time frame: 1 year post-operative
Agreement between OF classification and investigators
Time frame: 1 year post-operative
Validation of AO PROST
Time frame: 1 year post-operative
Health economic analyses
Time frame: 1 year post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoporotic Fractures
Active, not recruitingObservational study
Quebec Registry for Atypical Femur Fractures
Atypical Femur Fracture
Not yet recruitingObservational study
Functional Outcomes in Older Adults With Fragility Fractures of the Pelvis: The FFP-France Study
Fragility Fractures of the Pelvis (FFP), Osteoporotic Fractures
Not yet recruiting
Sacroplasty for Sacral Insufficiency Fractures.
Sacral Fracture, Osteoporotic Fracture
Active, not recruitingPhase 1
Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101
Osteoporotic Fracture
Not yet recruiting
Post-osteoporotic Fracture Exercise Program
Osteoporosis, Osteoporotic Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klaus Schnake, MD principal investigator
Center for Spinal and Scoliosis Surgery
15 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Fractures and Osteoporosis, run by AO Foundation, AO Spine at 15 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Argentina, Brazil, Chile, Egypt and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Thomas Thomas, PhD (+41 79 671 47 98, felix.thomas@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to mobility (time frame: From day of treatment to the end of the first 3 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.