FRACTURE REDUCTION EVALUATION (FREE) STUDY SUMMARY BALLOON KYPHOPLASTY VS. NON-SURGICAL MANAGEMENT

KEY CLINICAL OUTCOMES AT 12 AND 24 MONTHS

In the largest randomized controlled trial comparing balloon kyphoplasty (BKP) to non-surgical management (NSM) in patients with osteoporosis, balloon kyphoplasty was shown to be more effective than non-surgical management for the treatment of acute vertebral compression fractures (VCFs) at 12 months¹ and 24 months².

GREATER PATIENT SATISFACTION^1,2

BKP patients were significantly more satisfied than those treated non-surgically at all time points through 24 months.

COMPARABLE SAFETY RESULTS

There were similarities in overall frequencies of adverse events and serious adverse events between treatment groups during the 24-month study.²

• The kyphoplasty group had 11 patients (7.4%) with new clinical fractures that the investigator considered possibly or probably related to cement.
• There was no statistically significant difference between BKP and NSM in the number of patients with subsequent radiographic fractures or subsequent radiographic adjacent fractures.
• One hematoma SAE at the surgical site was device-related and one exacerbation of a recurrent urinary tract infection SAE (owing to catheterization) occurred within 2 days of surgery and was considered procedure-related.
• There were two serious adverse events related to bone cement that occurred after 1 year. The patient who had the urinary tract infection (above) also developed spondylitis near the cement in the treated vertebral body 376 days after surgery; biopsy indicated that the bacterium causing the urinary infection was the same as that causing the spondylitis. Another patient had a recurrent fracture of an originally treated level with subsequent anterior migration of the cement. These serious adverse events were uncommon and should be monitored.
• One patient from each treatment group terminated the study early owing to an AE during the 24-month follow-up period.
• There were 23 deaths, 12 in the kyphoplasty group and 11 in the nonsurgical group. All deaths were considered unrelated to treatment.

STUDY DESIGN AND FOLLOW UP

RANDOMIZED CONTROLLED TRIAL

• Patients (300) were randomly assigned by computer-generated sequence to either balloon kyphoplasty (n=149) or non-surgical care* (n=151).
• Investigators referred all participants in both groups for treatment with calcium and vitamin D supplements and antiresorptive or anabolic agents.

PARTICIPATING CENTERS

• 21 European sites
• 8 countries (Germany, France, Sweden, The United Kingdom, Italy, Austria, The Netherlands and Belgium)

PATIENT INCLUSION

• 1-3 vertebral fractures between T5 and L5
• At least 1 fracture with edema on MRI
• At least 1 fracture with ≥ 15% loss of vertebral body height on X-ray
• Fracture(s) caused by osteopenia due to primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors
• Back pain score ≥ 4 (on a scale of 0=no pain to 10=worst pain imaginable)

PATIENT EXCLUSION

• Patient age ≤ 21 years
• Fracture age > than 3 months
• Previous vertebroplasty
• Pedicle fracture
• Neurological deficit
• Radicular pain
• Spinal canal narrowing
• Spinal cord compression
• History of back disability unrelated to VCFs
• Dementia
• Non-ambulatory prior to VCFs
• High-energy traumatic fractures

FOLLOW-UP

• Follow-up at 1, 3, 6, 12, and 24 months

STUDY ENDPOINTS

Balloon kyphoplasty was shown to be more effective than non-surgical management for the treatment of acute VCFs.

PRIMARY ENDPOINT

• SF-36 PCS (Physical Component Summary) (scaled 0-100) 
• The difference in change from baseline at 1 month
• Validated global quality of life measure, weighted on physical abilities
• Normal range for people over the age of 65 is 8-59 points 

SECONDARY ENDPOINTS

• Quality of Life
  • SF-36 subscales (scaled 0-100) [20]
  • EQ-5D (EuroQol-5 Domain) health outcome questionnaire (scaled 0-1) 
• Back Function & Mobility
  • Roland-Morris back function disability questionnaire (scaled 0-24) 
  • Reduced activity days due to back pain during the previous 14 days 
• Back Pain
  • Back pain score (scaled 0-10) 
  • Narcotic analgesic use (percent of patients taking opioids)
• Adverse Events (device- and procedure-related)
  • All adverse events and serious adverse events, defined per IOS 14155, were reported; investigators assessed whether they were device- or procedure-related.
• Radiographicassessments
• Economic data