Multicentre prospective randomised controlled non-inferiority trial on the efficacy and safety of minimally invasive SAIF vertebral reconstruction technique versus spinal fixation in unstable osteoporotic vertebral compression fractures: a protocol

Introduction Osteoporotic vertebral fractures (OVFs) significantly impact morbidity, mortality, function and quality of life. Stable fractures with controllable pain can be managed conservatively. Those that remain painful can be treated with minimally invasive measures of vertebral augmentation (VA). In contrast, severe and unstable OVFs risk collapse, progressive kyphosis and neurological damage. Conventional VA is considered insufficient for these unstable fractures, making surgical stabilisation necessary to restore spinal load-bearing capacity, and allow fast and painless mobilisation. However, spinal surgery in elderly osteoporotic patients is challenging due to tissue fragility and common comorbidities. In addition, poor bone quality increases the risk of surgical implant failure, new fractures, complications and re-intervention. This trial aims to assess the non-inferiority of a novel minimally invasive interventional technique, called stent-screw assisted internal fixation (SAIF), compared with multilevel surgical stabilisation in terms of quality of life and radiological outcomes such as vertebral height restoration and kyphotic correction in patients with unstable OVFs.Introduction Osteoporotic vertebral fractures (OVFs) significantly impact morbidity, mortality, function and quality of life. Stable fractures with controllable pain can be managed conservatively. Those that remain painful can be treated with minimally invasive measures of vertebral augmentation (VA). In contrast, severe and unstable OVFs risk collapse, progressive kyphosis and neurological damage. Conventional VA is considered insufficient for these unstable fractures, making surgical stabilisation necessary to restore spinal load-bearing capacity, and allow fast and painless mobilisation. However, spinal surgery in elderly osteoporotic patients is challenging due to tissue fragility and common comorbidities. In addition, poor bone quality increases the risk of surgical implant failure, new fractures, complications and re-intervention. This trial aims to assess the non-inferiority of a novel minimally invasive interventional technique, called stent-screw assisted internal fixation (SAIF), compared with multilevel surgical stabilisation in terms of quality of life and radiological outcomes such as vertebral height restoration and kyphotic correction in patients with unstable OVFs.Methods and analysis This is a multicentre, parallel-group, randomised controlled non-inferiority trial that will be conducted in four European centres. A total of 140 patients with type Osteoporotic Fracture (OF) 3-5 OVFs (according to the AO Spine-DGOU Osteoporotic Fracture Classification System) will be randomised 1:1 to receive either SAIF intervention or surgical stabilisation. The primary outcome is to determine whether the effect of SAIF intervention is not inferior to surgical stabilisation on pain and quality of life at 1-year follow-up. The principal secondary outcomes are to evaluate whether the effect of the SAIF intervention is not inferior to surgical stabilisation in terms of radiological outcome and cost-effectiveness.Methods and analysis This is a multicentre, parallel-group, randomised controlled non-inferiority trial that will be conducted in four European centres. A total of 140 patients with type Osteoporotic Fracture (OF) 3-5 OVFs (according to the AO Spine-DGOU Osteoporotic Fracture Classification System) will be randomised 1:1 to receive either SAIF intervention or surgical stabilisation.The primary outcome is to determine whether the effect of SAIF intervention is not inferior to surgical stabilisation on pain and quality of life at 1-year follow-up. The principal secondary outcomes are to evaluate whether the effect of the SAIF intervention is not inferior to surgical stabilisation in terms of radiological outcome and cost-effectiveness.Methods and analysis This is a multicentre, parallel-group, randomised controlled non-inferiority trial that will be conducted in four European centres. A total of 140 patients with type Osteoporotic Fracture (OF) 3-5 OVFs (according to the AO Spine-DGOU Osteoporotic Fracture Classification System) will be randomised 1:1 to receive either SAIF intervention or surgical stabilisation. The primary outcome is to determine whether the effect of SAIF intervention is not inferior to surgical stabilisation on pain and quality of life at 1-year follow-up. The principal secondary outcomes are to evaluate whether the effect of the SAIF intervention is not inferior to surgical stabilisation in terms of radiological outcome and cost-effectiveness.Methods and analysis This is a multicentre, parallel-group, randomised controlled non-inferiority trial that will be conducted in four European centres. A total of 140 patients with type Osteoporotic Fracture (OF) 3-5 OVFs (according to the AO Spine-DGOU Osteoporotic Fracture Classification System) will be randomised 1:1 to receive either SAIF intervention or surgical stabilisation. The primary outcome is to determine whether the effect of SAIF intervention is not inferior to surgical stabilisation on pain and quality of life at 1-year follow-up. The principal secondary outcomes are to evaluate whether the effect of the SAIF intervention is not inferior to surgical stabilisation in terms of radiological outcome and cost-effectiveness.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE 4004). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.Trial registration number NCT07071870.