RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures

NCT07071870 | Not Yet Recruiting

• 1 other identifier: 2021-02396
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporotic vertebral fractures (OVF) represent a significant cause of morbidity, mortality, decreased level of function and quality of life. The most severe OVFs are unstable and in these cases surgical stabilization, with various techniques, is considered necessary to restore the physiological loading capacity of the spine, and allow fast and painless mobilization. Unfortunately, the elderly, osteoporotic patient population poses serious challenges to spinal surgery, due to tissue frailty and frequent comorbidities. The purpose of this study is to evaluate the effectiveness and safety of the SAIF intervention in comparison with multilevel surgical stabilization in participants with unstable OVFs.

Conditions

Unstable Osteoporotic Vertebral Compression Fractures

Keywords

Stent-screw Assisted Internal Fixation (SAIF); Surgical stabilization

Outcome Measures

Primary Outcomes (1)

• Change in the Quality of Life questionnaire of the European Foundation of Osteoporosis (QUALEFFO) score.

  The QUALEFFO score is patient-reported and comprises 41 items on five domains: pain, physical function, social function, general health perception, and mental function. All answers are standardized so that 1 represents the best and 5 (or 3, or 4) represents the worst quality of life. The total score is calculated by summing all answers of questions 1-41. The raw total score ranges from 41 to 205 and this is transformed to scores from 0 to 100. A high score indicates a poor quality of life.

  at 12 months from baseline.

Secondary Outcomes (11)

• restoration of angular kyphosis at index level

  pre-operative and at 1, 6 and 12 months follow up

• vertebral body height restoration

  Baseline and 1 day after the intervention

• global kyphosis/lordosis

  pre-operative and at 1, 6 and 12 months follow up

• Global Sagittal Balance

  pre-operative and at 1, 6 and 12 months follow up

• length of operation

  Perioperative

Other Outcomes (1)

• Safety outcomes

  up to 12 months.

Study Arms (2)

Stent-screw Assisted Internal Fixation (SAIF)

EXPERIMENTAL

SAIF technique, performed by percutaneous access, consists of, implanting vertebral body stents (VBS) under fluoroscopic guidance, followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws that act as anchors to the posterior elements for the cement/stent complex. The screws reduce the risk of stent mobilization in a non-intact vertebral body (VB) cortical shell and bridge middle column and pedicular fractures.

Procedure: Stent-screw Assisted Internal Fixation (SAIF)

Surgical stabilization

ACTIVE COMPARATOR

Spinal stabilization with augmented or non-augmented pedicle screws bridging the fractured vertebra, with or without (percutaneous) cement augmentation of the fractured vertebra, with or without reconstruction of the anterior column via anterior or lateral approach.

Procedure: Surgical stabilization

Interventions

Stent-screw Assisted Internal Fixation (SAIF) PROCEDURE

Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws

Also known as: SAIF

Stent-screw Assisted Internal Fixation (SAIF)

Surgical stabilization PROCEDURE

Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra

Surgical stabilization

Eligibility Criteria

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

You may qualify if:

• one to two unstable OVFs\* type OF 3-5\*\* as assessed on CT scan, located between T2 and L5, of age \<3 months or with persistent edema on STIR, or with pseudarthrosis, at the index level
• patients reporting pain upon mobilization
• a diagnosis of osteoporosis, based on a DEXA T-score ≤ -2.5, or on a spontaneous thoracolumbar vertebral fracture or a vertebral fracture caused by minor trauma
• able to read and speak the official language of the region of the site,
• informed consent
• additional OVF without unstable features (OF 1-2) allowed \*\* OF-Classification

You may not qualify if:

• compressive neurologic symptoms such as myelopathy or radiculopathy with motor deficit
• acute infection
• spinal malignancy
• comorbid severe psychiatric conditions
• known or suspected non-compliance, drug or alcohol abuse
• known hypersensitivity or allergy to the investigational product
• inability to follow the procedures of the study

Sponsors & Collaborators

• Eva Koetsier MD PhD: lead
• Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC): collaborator

Study Sites (1)

EOC Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

Central Study Contacts

Eva Koetsier, MD PhD LLM

CONTACT

0041(0)783388933; Eva.Koetsier@eoc.ch

Alessandro Cianfoni, MD PhD

CONTACT

0041 (0)918116027; Alessandro.Cianfoni@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD LLM

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 17, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months following publication and available for up to 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. Data will be shared after approval and signing of a data access agreement.

Locations

CH (1)