FREE study compares outcomes of vertebral fracture treatments

Acute vertebral fractures are commonly treated with conservative measures aimed at reducing pain. But according to the results of a study sponsored by Kyphon and presented at the AAOS 2010 Annual Meeting, the key to restoring good quality of life and functionality in patients with vertebral compression fractures lies not in bed rest, back bracing, physical therapy, or analgesia, but in stabilization and surgical correction of the deformity.

“Our study compared the results of nonsurgical treatment to balloon kyphoplasty, a minimally invasive procedure that restores and stabilizes acute vertebral fractures,” said co-author Jan Van Meirhaeghe, MD. “We found that kyphoplasty improved quality of life and reduced back pain and disability.”

According to Dr. Van Meirhaeghe, the study’s previously published 1-year follow-up results—as well as the 2-year follow-up results he presented at the meeting—indicate that kyphoplasty should be considered as an early treatment option for acute vertebral fractures.

Conducting the FREE Study
The Fracture Reduction and Evaluation (FREE) study—a multicenter, randomized, controlled trial conducted at 21 centers throughout the European Union—included 300 patients. All patients were stratified according to gender, bisphosphonate or corticosteroid usage, and etiology of the fracture (primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors).

Patients were randomly assigned to the balloon kyphoplasty group (n = 149) or the nonsurgical management group (n = 151). Both groups had 77 percent females and 23 percent males, with a mean age of 74 years in the nonsurgical group and a mean age of 72.2 years in the balloon kyphoplasty group.

Patients had up to three vertebral fractures (at least one considered acute based on the presence of edema detected via magnetic resonance imaging scan and at least one fracture with vertebral height loss of 15 percent or more) in the T5-L5 region. Fractures that scored 4 or higher on the visual analog scale (VAS) for back pain were diagnosed as painful. Bisphosphonate and corticosteroid usage were comparable in both groups.

“Nonsurgical treatment followed the hospital protocol of pain medication, bed rest, bracing, physiotherapy, and walking aids,” said Dr. Van Meirhaeghe. “Both treatment groups received calcium and vitamin D supplements and antiresorptive or anabolic treatment for osteoporosis.”

Patients in the balloon kyphoplasty group were treated at one level (67.1 percent), two levels (19.5 percent), or three levels (6.7 percent).

Results point to kyphoplasty
From baseline to 1 month, the mean Short Form 36 Physical Component Summary (PCS) score improved 5.1 points (p < 0.0001) more in the kyphoplasty group than in the nonsurgical group. In addition, the mean PCS score improved by an average of 3.0 points more (p = 0.002) in the kyphoplasty group than in the nonsurgical group during the course of the 2-year study.

Dr. Van Meirhaeghe pointed out that the treatment effect was not uniform during the follow-up period. Although the balloon kyphoplasty group showed more early improvement, the nonsurgical group showed more incremental improvement over time.

“As indicated by VAS scores,” said Dr. Van Meirhaeghe, “patients treated with balloon kyphoplasty showed statistically significant and clinically meaningful improvement regarding pain reduction as early as in 7 days. This improvement was also sustained throughout the 2-year study.”

Based on patient self-assessment scores, patients in the balloon kyphoplasty group showed a statistically significant average improvement over those in the nonsurgical group during the 2-year follow-up study. The percentage of patients who needed narcotic medication was significantly lower in the balloon kyphoplasty group for the first 6 months, and balloon kyphoplasty resulted in less disability as measured by the Roland-Morris Back Disability Index when averaged over 2 years (p < 0.0001).

“This improvement in back disability is reflected in the number of limited activity days and bed rest days due to back pain for kyphoplasty patients,” said Dr. Van Meirhaeghe. “When averaged over the 2 year follow-up, kyphoplasty resulted in 2.2 fewer days (p < 0.0001, range 0.9 to 3.4 days) of limited activity within a 2-week period. Thus, it is estimated that balloon kyphoplasty patients have approximately 112 fewer days of limited activity within 2 years compared to their nonsurgical counterparts.”

No difference in the number of patients with adverse events was found between the two groups. Although most patients used bisphosphonates or other osteoporosis treatments, the rate of new radiographic fractures (most of which occurred within 12 months) in both groups was high and not significantly different. At 24 months’ follow-up, 43 of 112 patients in the kyphoplasty group and 30 of 92 patients in the nonsurgical group had new fractures (6 percent difference; p = 0.46).

“We concluded that balloon kyphoplasty is superior to nonsurgical care for this patient population,” he said.

Dr. Van Meirhaeghe’s coauthors for, “Balloon Kyphoplasty vs Non-surgical Care: 2 Year Outcome of a Randomised Controlled Trial (FREE)” include Douglas Wardlaw, MB, ChB, ChM, FRCSEd (lead author); Steven Boonen, MD, PhD; and Leonard Bastian, MD. Dr. Van Meirhaeghe reports the following conflicts: Kyphon, Inc.; Medtronic; Synthes; and Stryker. The study was sponsored by Kyphon, Inc.

Dr. Boonen—Medtronic; Dr. Bastian—Kyphon, Inc., Medtronic, and Zimmer; Mr. Wardlaw—Medtronic and Zimmer.

Jennie McKee is a staff writer for AAOS Now. She can be reached at mckee@aaos.org

Bottom line

• Patients with acute vertebral fractures treated with balloon kyphoplasty showed more early improvement (reduced pain), which was sustained over time.
• Patients treated nonsurgically had incremental improvement over time.
• Patients treated with balloon kyphoplasty had fewer days of limited activity over 2 years.