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

NCT07027306 | Recruiting

• 1 other identifier: TL-OF
• Study Type: observational
• Target: 648
• Locations: 14 countries
• Sites: 15

Brief 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). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \[MRI\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \[CT\] or MRI).

Conditions

Osteoporotic Fractures; Osteoporosis

Outcome Measures

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.

  From day of treatment to the end of the first 3 months after treatment.

Secondary Outcomes (19)

• Comparison of return to mobility (categorical scale)

  At all predefined visits from discharge to 12months post treatment

• Comparison of the extent of return to mobility

  3 months post-operative and 12-months postoperative

• Comparison of clinical outcome

  3 months post-operative and 12-months postoperative

• Comparison of the proportion return to mobility

  3 months post-operative and 12-months postoperative

• Comparison of Timed Up & Go test

  3 months post-operative and 12-months postoperative

Study Arms (2)

OF score accordance group

Initial treatment decision in accordance with the OF score recommendations

Procedure: Posterior stabilization (pedicle screws)

OF score discordance group

Initial treatment decision in discordance with the OF score recommendations

Procedure: Posterior stabilization (pedicle screws)

Interventions

Posterior stabilization (pedicle screws) PROCEDURE

* 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

Also known as: Kyphoplasty, Vertebroplasty

OF score accordance group; OF score discordance group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Foundation, AO Spine: lead

Study Sites (15)

University of California San Francisco (USCF) Department of Orthopaedic Surgery

San Francisco, California, 94143-0728, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107-4216, United States

NOT YET RECRUITING

Sanatorio Güemes

Buenos Aires, 1240, Argentina

NOT YET RECRUITING

Cajuru University Hospital

Curitiba, 80050-50, Brazil

NOT YET RECRUITING

Department of Orthopedic Surgery, Clinica Alemana de Santiago

Santiago, 5951, Chile

NOT YET RECRUITING

Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine

Asyut, 71526, Egypt

NOT YET RECRUITING

Tampere University Hospital

Tampere, 33521, Finland

NOT YET RECRUITING

Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien

Erlangen, 91054, Germany

NOT YET RECRUITING

PGIMER - Postgraduate Institute of Medical Education and Research

Chandigarh, 160 012, India

NOT YET RECRUITING

Dokkyo Medical University Hospital

Tochigi, 321-0293, Japan

NOT YET RECRUITING

Island Hospital Spine Centre

George Town, 10450, Malaysia

RECRUITING

Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu"

Iași, 700309, Romania

RECRUITING

Security Force Hospital

Riyāḑ, 11564, Saudi Arabia

RECRUITING

Spital Emmental - Orthopädie Sonnenhof

Burgdorf, 3400, Switzerland

NOT YET RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoporotic Fractures; Osteoporosis

Interventions

Pedicle Screws; Kyphoplasty; Vertebroplasty

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Klaus Schnake, MD

  Center for Spinal and Scoliosis Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Thomas Thomas, PhD

CONTACT

+41 79 671 47 98; felix.thomas@aofoundation.org

Maria C Medina Giner

CONTACT

0795456120; maria.medinaginer@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: June 18, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

EG (1); CH (1); US (2); DE (1); IN (1); FI (1); CL (1); BR (1); JP (1); RO (1); MY (1); SA (1); GB (1); AR (1)