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

Official title

The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study

Overview

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).

Interventions

• Procedure Posterior stabilization (pedicle screws)
  * 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 anterio

Primary outcome measures

• Return to mobility [Time frame: From day of treatment to the end of the first 3 months after treatment.]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• University of California San Francisco (USCF) Department of Orthopaedic Surgery — San Francisco
• Thomas Jefferson University Hospital — Philadelphia

Argentina · 1 center

• Sanatorio Güemes — Buenos Aires

Brazil · 1 center

• Cajuru University Hospital — Curitiba

Chile · 1 center

• Department of Orthopedic Surgery, Clinica Alemana de Santiago — Santiago

Egypt · 1 center

• Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine — Asyut

Finland · 1 center

• Tampere University Hospital — Tampere

Germany · 1 center

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

India · 1 center

• PGIMER - Postgraduate Institute of Medical Education and Research — Chandigarh

Japan · 1 center

• Dokkyo Medical University Hospital — Tochigi

Malaysia · 1 center

• Island Hospital Spine Centre — George Town

Romania · 1 center

• Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu" — Iași

Saudi Arabia · 1 center

• Security Force Hospital — Riyāḑ

Switzerland · 1 center

• Spital Emmental - Orthopädie Sonnenhof — Burgdorf

United Kingdom · 1 center

• King's College Hospital — London

Identifiers

NCT: NCT07027306 · TL-OF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗