The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 648
- 试验地点
- 15
- 主要终点
- Return to mobility
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
OF score accordance group
Initial treatment decision in accordance with the OF score recommendations
干预措施: Posterior stabilization (pedicle screws) (Procedure)
OF score discordance group
Initial treatment decision in discordance with the OF score recommendations
干预措施: Posterior stabilization (pedicle screws) (Procedure)
结局指标
主要结局
Return to mobility
时间窗: 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.
次要结局
- Comparison of clinical outcome(3 months post-operative and 12-months postoperative)
- Comparison of the extent of return to mobility(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)
- Comparison of daily activities(3 months post-operative and 12-months postoperative)
- Comparison of pain NRS (Numeric Rate Scale)(3 months post-operative and 12-months postoperative)
- Comparison of ODI (Oswestry Disability Index)(3 months post-operative and 12-months postoperative)
- Comparison of quality of live(3 months post-operative and 12-months postoperative)
- Comparison of the AO Spine PROST(3 months post-operative and 12-months postoperative)
- Comparison of the overall satisfaction(3 months post-operative and 12-months postoperative)
- Complications-determination in relation to surgery(1 year post-operative)
- Complications-determination in relation to OF subtype(1 year post-operative)
- Determination of type of treatment(1 year post-operative)
- Determination of rate and type of surgical treatment(1 year post-operative)
- Proportion between surgery after initial non-surgery treatment(1 year post-operative)
- Agreement between OF classification and investigators(1 year post-operative)
- Validation of AO PROST(1 year post-operative)
- Health economic analyses(1 year post-operative)
- Comparison of return to mobility (categorical scale)(At all predefined visits from discharge to 12months post treatment)