Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.


Clinical Trial Description

Vertebral compression fracture (VCF) is a very common medical problem and describes the collapse of a vertebral body (VB) in the spine. VCF can lead to severe pain, decreased physical function, spinal deformity and in rare cases thoracic or abdominal wall deformities, that can impair pulmonary and gastrointestinal function. A VCF can occur in patients with healthy spines upon severe trauma, in patients suffering from osteoporosis or in patients with metastatic tumors. Currently available therapy for VCF includes medical management, surgical treatments and vertebral augmentation (VA). Medical management consists of bed rest followed by early mobilization and analgesic medications. Surgical options include spinal stabilization with rods and screws. VA procedures attempt to stabilize the spine and reduce vertical compression by adding material to the spine. Kyphoplasty is a commonly performed VA procedure. In kyphoplasty, a surgical instrument is used to reduce the collapsed VB towards its original shape. Reduction of the fractured VB is thought to be beneficial since (1) it may reduce anterior directed compressive forces resulting from kyphosis of the spine due to the fracture, and (2) it may reduce some physiologic abnormalities due to kyphosis, such as restrictive lung disease or abdominal compression. After fracture reduction, bone cement is placed in the VB to stabilize the reduction. Fracture reduction follows the orthopedic general principles of fracture repair: reduction and stabilization. Primary objective of this observational study is to compare the effectiveness of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement for use in VCF reduction, to confirm the performance of those two devices and to investigate potential major adverse events associated with the use of the device in patients treated in a controlled setting when used according to the IFU. Secondary objective is to compare the safety of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04581707
Study type Observational
Source University Hospital Tuebingen
Contact Lisanne Exner
Phone +4970712986646
Email Lisanne.Exner@med.uni-tuebingen.de
Status Recruiting
Phase
Start date March 1, 2020
Completion date October 2021

See also
  Status Clinical Trial Phase
Completed NCT01643395 - VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures Phase 3
Enrolling by invitation NCT05018637 - Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture Phase 2
Completed NCT03523000 - Determining the Prognostic Value of Continuous Intrathecal Infusion Phase 4
Recruiting NCT04835428 - STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures N/A
Recruiting NCT04821739 - RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures N/A
Completed NCT04135755 - The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects
Recruiting NCT05676320 - Investigating Bone Cement With or Without Inossiaâ„¢ Cement Softener for Vertebral Compression Fractures N/A
Completed NCT01383616 - Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures Phase 4
Recruiting NCT05912504 - Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey
Completed NCT06153576 - The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Completed NCT03580434 - The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System N/A
Suspended NCT03651804 - Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures Phase 4