Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham control intervention failed to show an advantage of vertebroplasty over placebo for participants with acute, subacute, and chronic fractures or severe pain. In the third RCT, PVP compared to optimal conservative treatment showed significant immediate postoperative pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues, this study is initiated to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

NCT03360383

Spinal Fractures

UNKNOWN NA

VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

NCT01643395

Vertebral Compression Fracture Spinal Trauma

COMPLETED PHASE3

CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation

NCT05071625

Vertebral Fracture Vertebral Trauma

COMPLETED

Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

NCT00635297

Osteoporosis Vertebral Fracture

SUSPENDED NA

Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

NCT00749060

Osteoporotic Vertebral Fracture Between T5 and L5 of Less Than 6 Weeks Duration

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Osteoporotic vertebral fractures (OVCFs) are common in the elderly population, with an estimated 1.4 million new fractures occurring every year worldwide. Patients may present with pain and frequently require hospital admission for analgesia, bed rest, and physical support (bracing). While their back pain may last for 6-12 weeks, complications such as pneumonia, decubitus ulcers, venous thromboembolism, and even death may occur. Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. So this study is to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.

This study is a multicenter randomized controlled trial (RCT), Participants in this study will be allocated randomly to PVP or conservative treatment.All Participants will be asked to fill out standard questionnaires to provide clinical information at baseline (the day of randomization), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment. Cross-over will not be offered before 12 months after randomization. All standard questionnaires (except the 1-day questionnaire) consist of the VAS score, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), EQ-5D, and Roland-Morris Disability (RMD) Questionnaire. Furthermore,additional questions about pain treatment, hospital stay, outpatient visits,medical aids, and medical costs will be completed with the help of a nurse practitioner.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Osteoporotic Spinal Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Percutaneous vertebroplasty

Group Type EXPERIMENTAL

Percutaneous vertebroplasty

Intervention Type PROCEDURE

Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture

Conservative therapy

Group Type ACTIVE_COMPARATOR

Conservative therapy

Intervention Type OTHER

Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous vertebroplasty

Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture

Intervention Type PROCEDURE

Conservative therapy

Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 50 Years and older
* have a confirmed diagnosis of osteoporosis or osteopenia.
* acute, painful OVCFs from T4-L5
* clinical onset \< 6 weeks
* vertebral compression fracture on spine radiograph (minimum 15% height loss)
* Visual Analogue Scale \[VAS\] score ≥ 4 for pain

Exclusion Criteria

* severe cardio-pulmonary condition
* untreatable coagulopathy
* active local or systemic infection
* current malignancy, or radicular or caudal compression syndrome

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No