Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

Phase 3

Completed

Conditions: Spinal Fractures
Osteoporosis

Interventions: Device: Percutaneous vertebroplasty
Procedure: Sham vertebroplasty

Registration Number: NCT00068822

Lead Sponsor: Mayo Clinic

Brief Summary: Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.

Detailed Description: Spontaneous, atraumatic compression fractures due to osteoporosis occur in more than 700,000 patients per year. Pain associated with these fractures may be excruciating, but before the advent of percutaneous vertebroplasty, treatment options were limited. Analgesic medications, bed rest, and bracing have been the mainstays of treatment, but each of these therapies has substantial limitations.

Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (medical cement) into the fractured vertebra, has disseminated rapidly. However, evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled, nonblinded, small case studies. Even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case studies have not accounted for numerous important potential biases, including the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. This study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures.

Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure (placebo control group). Participants may have up to 2 spinal levels treated. Participants will be enrolled in the study for 1 year and will have study visits at entry and Months 1 and 12. There will also be phone visits at Days 1, 2, 3, and 14 and Months 3 and 6. After Month 1, crossover from the placebo group to the vertebroplasty group will be allowed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 131

Inclusion Criteria

Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film
Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old
Pain not responsive to standard medical therapy
Current rating for pain intensity of at least 3 on a scale of 0 to 10

Exclusion Criteria

Evidence or suspicion of malignant tumor or spinal canal compromise
Concomitant hip fracture
Local or systemic infection
Uncorrectable bleeding diatheses
Surgery within the previous 60 days
Lack of access to telephone
Inability to communicate in English
Dementia
Pregnancy
Abnormal renal function or anticipated venography
Conscious sedation is contraindicated for subject

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vertebroplasty	Percutaneous vertebroplasty	Participants will receive percutaneous vertebroplasty
Control Group	Sham vertebroplasty	Participants will receive sham vertebroplasty without PMMA

Primary Outcome Measures

Name	Time	Method
Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month	1 month after procedure	Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.
Patient's Rating of Average Pain at 1 Month	1 month	Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.

Secondary Outcome Measures

Name	Time	Method
Patient Well-being at 1 Month	Month 1	Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain). European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL. Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability.