Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral

Status Completed

Clinical Trial Summary

This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.

Clinical Trial Description

This is a single arm, post market surveillance pilot study of an FDA cleared product, to evaluate the procedural and clinical profile of an ultra high viscosity cement vertebral augmentation system for the treatment of vertebral compression vertebral fractures due to osteoporosis.

Twenty (20) consenting evaluable adult male and female patients between the ages of 50 and 90 who meet the inclusion criteria for the study and are treated using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement as part of their standard treatment for osteoporotic vertebral compression fractures will be enrolled in the study.

The participants will be followed after the procedure for 3 months by telephone and/or mailed questionnaire by an IRB certified member of the research team. Information collected will include the patient's ability to ambulate independently and activity level pre and post-treatment, decrease or increase in pain level compared to pre-treatment, and monitoring adverse events. Data will be collected at enrollment, procedure, discharge (or 1 day post procedure), 1 week, 1 month and 3 months post procedure using the Visual Analog Scale (VAS) for pain score, Oswestry Disability Index. Standard of care radiographs and MRI or CT/bone scan are evaluated by a board certified radiologist. The data collected will be compared to measure outcomes. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01839682
Study type	Observational
Source	Cedars-Sinai Medical Center
Contact
Status	Completed
Phase	N/A
Start date	June 2009
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06287502` - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis	N/A
Completed	`NCT03822078` - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women	Phase 1
Recruiting	`NCT05845021` - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04736693` - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting	`NCT06431867` - Primary Care Management of Osteoporosis in Older Women
Completed	`NCT02922478` - Role of Comorbidities in Chronic Heart Failure Study
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting	`NCT02616627` - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Active, not recruiting	`NCT02617303` - Prevention of Falls and Its Consequences in Elderly People	N/A
Completed	`NCT02566655` - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis	Phase 1
Not yet recruiting	`NCT02223572` - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture	N/A
Completed	`NCT02559648` - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis	Phase 2
Completed	`NCT03420716` - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women	N/A
Completed	`NCT02003716` - DeFRA Questionnaire as an Anamnestic Form	N/A
Unknown status	`NCT01913834` - Nasally and sc Administered Teriparatide in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT01854086` - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday	N/A
Completed	`NCT01757340` - Calorie Restriction With Leucine Supplementation	N/A
Completed	`NCT01401556` - C-STOP Fracture Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms