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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.

Results

Between February 2003 and December 2005, 70 patients were randomized to BKP (n=35) or to standard medical treatment (n=35). Three patients in the Control group declined to participate in an economic evaluation, and only patients answering EQ-5D at all FU occasions (1-3-6-12-24 months) were included in the analyses, leaving in all 63 patients, BKP=32, Control=31. Baseline data were similar. The mean age in the BKP group was 72 years (71% women) vs. 75 years (78% women) in the Control group. Baseline difference in QoL was adjusted for using statistical methods. There were no cross overs. Four patients in the BKP group and three patients in the Control group died within two years of causes not related to the VCF. Costs were collected using “cost diaries” in mailed questionnaires after 1-3-6-12-18-24 months. Costs and EQ-5D values (0 at FU after death) were carried forward. Total mean societal cost per patient for BKP and Control was SEK 160,017 (SD 151,083) and SEK 84,816 (SD 40,954), respectively. The difference was significant 75,198 (95% CI 16,037 to 120,104). The accumulated mean difference in QALYs was 0.085 (−0.132 to 0.306) units in favour of BKP. Cost per QALY gained using BKP was SEK 884,682 (EURO 92,154) with high uncertainty assessed using the bootstrapping technique, and demonstrated on the cost-effectiveness plane and on the acceptability curve. When the EQ-5D values from all patients in the FREE trials were included in a sensitivity analysis, cost/QALY was SEK 359,146 (EURO 37,411) Conclusion: Costs were significantly higher for BKP compared with standard medical treatment, with no significant difference in QALYs gained. In this selected patient population with vertebral compression fracture due to osteoporosis, BKP could not be concluded as cost-effective after two years


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 310 - 310
1 May 2010
Rolfson O Digas G Herberts P Borgström F Garellick G
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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.