Percutaneous kyphoplasty versus conservative treatment in acute and subacute osteoporotic vertebral compression fractures (OVCF): A double-blinded, randomized controlled clinical trial (RCT) in the population of Western China

BACKGROUND CONTEXT:

Vertebral compression fracture (VCF) is one of the most common causes of osteoporosis fractures. There are over 700,000 VCF patients yearly. Percutaneous kyphoplasty (PKP) is a minimally invasive surgical approach that uses interventional radiology technique and involves the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. In China, with no randomized controlled study reported in this regard, it is still controversial to choose between PKP and conservative treatment for VCF patients. In this study, we treated 164 osteoporotic VCF (OVCF) patients with either PKP or CT method under a double-blinded, randomized controlled study between July 2007 and July 2010. In China, this study was Level I evidence according to US Preventive Services Task Force. The results were reported below.

PURPOSE:

Clinical efficacy comparisons between percutaneous kyphoplasty (PKP) and conservative treatment (CT) for osteoporotic vertebral compression fractures (OVCF) are reported.

SUMMARY OF BACKGROUND DATA:

This is the first RCT to compare percutaneous kyphoplasty with conservative treatment in acute and subacute osteoporotic vertebral compression fractures (OVCF) in Chinese population.

STUDY DESIGN/SETTING:

Double-blinded randomized controlled clinical trial (RCT).

PATIENT SAMPLE:

Between July 2007 and July 2010, 164 patients with acute (within 2 weeks) or sub-acute (2 to 8 weeks) OVCF were enrolled in this study.

OUTCOME MEASURES:

Visual analog scale (VAS), SF-36 form and the Dallas questionnaire were used to evaluate the physiological and psychological changes of patients.

METHODS:

Patients were randomly assigned to CT and PKP. In the PKP group, there were 47 men and 30 women, aged from 57 to 77 years (average, 67 years). In the CT group, there were 43 men and 44 women, aged from 60 to 82 years (average, 67 years). Improvement of symptoms, restoration of vertebral body height, correction of kyphosis, bone cement leakage, pain, physical and psychological outcomes were reported. VAS, SF-36 form and the Dallas questionnaire were used to evaluate the physiological and psychological changes of patients.

RESULTS:

The patients had an average follow-up of 9 months (from ± to 12 months). A considerable degree of pain relief was obtained in both groups at postoperation and 3-month follow-up (P<0.05). There was no significant difference between the 2 groups in terms of VAS scores at either preoperation or the last follow-up (P>0.05). However, a significant difference of VAS scores was observed at 24-hours postop (P<0.05). In the PKP group, the average anterior vertebral body height was restored by 27.9% (P<0.05) and the average vertebral kyphosis correction was 12.6° (P<0.05). There were no significant differences between the 2 groups in postoperative scores in Health Survey Short Form (standard physical components and standard psychological components), Dallas Pain Questionnaire (activities of daily living, work and play, anxiety and depression, social interests), Barthel index, Mini-Mental State Examination (P>0.05).

CONCLUSIONS:

Compared to the CT, application of PKP for acute and sub-acute PVCF has advantages such as immediate pain relief, early return to active lifestyle, restoration of the vertebral body height, correction of the kyphosis, and reduction of complication. Although CT could also improve the symptoms after 3 to ± months treatment, the restoration of vertebral body height and vertebral kyphosis correction is not ideal.