Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProf Nicolas Theumann
About this trial
The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >18 years.
Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
Disqualifiers
Infection
Vertebral body collapse to less than 1/3 (33%) of original height
Vertebral plana (>90% vertebral body collapse)
Spinal stenosis (retro pulsed fragments).
Trial population
Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Vertebroplasty
DeviceVertebral compression fractures treated with CONFIDENCE High Viscosity Cement
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: Vertebroplasty cohort1 intervention
Trial outcomes
Primary outcomes
1
Improvement of sagittal balance
measurement of sagittal vertical axis (SVA)
Time frame
Up to 12 months post index surgerySecondary outcomes
1
Improvement in Back Pain
Measured as NRS scale for back pain
Time frame
Up to 12 months post index surgery2
Quebec Score
Measured as the standard Quebec Score
Time frame
6-12 months post index surgery3
Complications
Time frame
Up to 12 months post-index surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof Nicolas Theumann
Lead sponsor
Hirslanden Clinique Bois-Cerf Lausanne
Sponsor institution
Johnson & Johnson
Collaborator
Dr Danoob Dalili
Collaborator
Source ClinicalTrials.gov