Background

Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally used in patients with painful vertebral compression fractures (VCF). In this multicenter Swedish RCT, we evaluated the cost-effectiveness of BKP compared with standard medical treatment, Control, in osteoporotic patients with acute/sub-acute VCF (<3 months). In a multicenter European clinical study (FREE trial) including 300 patients and FU after one year, BKP was suggested to be a safe and effective procedure in selected patients. The current study includes the Swedish patients in the FREE trial Method: Hospitalized patients with a back pain level of at least 4/10 on a visual analogue scale due to of VCF between Th5–L5 (confirmed by MRI) were randomized to either BKP or Control treatment (standard medical treatment with pain medication and functional support). All VCF-associated costs (hospital, primary care, rehabilitation, community care, private care, pharmaceuticals, assistance by relatives, work absenteeism) were identified and reported from the perspectives of cost to society, and costs to the healthcare system. Primary outcome was quality of life change (QoL) measured with the preference based EQ-5D instrument. The accumulated quality adjusted life years gained (QALYs) and costs per QALY gained was assessed. Willingness to pay (WTP) for a QALY gained in Sweden was estimated at approximately SEK 600,000 (EURO 62,500). Sensitivity analyses were performed.

Introduction: Many patients eligible for hip arthroplasty suffer from bilateral hip disease with indication for bilateral total hip replacement (BTHR). Traditionally two-stage BTHR is far more common than one-stage procedure due to the risk of complications. However, most studies are in favour of one-stage BTHR in the healthy and young people. This study was designed to further analyse mortality, outcome, complications and cost-effectiveness after one-stage BTHR surgery.

Patients and Methods: In this prospective matched control study we examined 32 patients with BTHR hybrid surgery. The control group of 32 patients with unilateral hybrid THR was derived from Sahlgrenska University hospital. The follow up time was 1 year. Medical records, cost per patient database, records from Swedish Social Insurance Administration and HRQoL outcome measurements from the Swedish Hip Arthroplasty Register were used for the analyses.

Mortality data from the Register regarding all 950 patients with one-stage BTHR surgery during the period 1992 until 2005 were compared to those 2577 who had had a twostage procedure with less than six months between the operations.

Preliminary Results: There were no major differences in complications. The intraoperative bleeding was higher in the BTHR patients and they required more blood transfusion. Length of hospital stay was in average 10,2 days for the one-stage BTHR group and 7,6 days for the unilateral group. Preoperative EQ-5D index was 0,14 in the BTHR group and 0,31 in the control group. Mean EQ-5D gain after 1 year was 0,77 and 0,40 respectively. Hospital costs were only 60% higher in the one-stage BTHR group. Among the employed patients there were no differences in days of sick pay and cost of sick pay in the two groups. Among the 950 subjects with one-stage BTHR surgery, the 90 day mortality was 0,32% compared to 0,42% in the group of 2577 patients with two-stage procedure.

Discussion: In healthy patients with bilateral hip disease requiring bilateral arthroplasty one-stage BTHR is highly cost-effective and safe. There is even lower 90 day mortality for the onestage operated subjects in the register but this is probably due to a natural selection of younger and healthier patients. The one-stage procedure reduces the total time of rehabilitation which is of particular importance for people in working age. Cautiously estimated, performing another 100 one-stage BTHR per year instead of two-stage procedure would save 16–20 million SEK yearly in Sweden.