Balloon Spacer Implant Is an "Intermediate Value" Innovation Relative to Partial Repair for Full-Thickness Massive Rotator Cuff Repairs: A Cost-Utility Analysis.

ABSTRACT

PURPOSE: To evaluate the cost-utility of a balloon spacer implant relative to partial repair (PR) for the surgical treatment of full-thickness massive rotator cuff tears (MRCTs). METHODS: A decision-analytic model comparing balloon spacer with PR was developed using data from a prospective, randomized, single-blinded, multicenter-controlled trial of 184 randomized patients. Our model was constructed on the basis of the various event pathways a patient could have after the procedure. The probability that each patient progressed to a given outcome and the quality-adjusted life years (QALY) associated with each outcome were derived from the clinical trial data. Incremental cost utility ratio (ICUR) and incremental net monetary benefit were calculated on the basis of a probabilistic sensitivity analysis using Monte Carlo simulations of 1,000 hypothetical patients progressing through the decision-analytic model. One-way sensitivity and threshold analyses were performed by varying cost, event probability, and QALY estimates. RESULTS: The balloon spacer had an ICUR of $106,851 (95% confidence interval $96,317-$119,143) relative to PR for surgical treatment of MRCT. Across all patients, the balloon spacer was associated with greater 2-year QALY gain compared with PR (0.20 ± 0.02 for balloon spacer vs 0.18 ± 0.02 for PR), but with substantially greater total 2-year cost ($9,701 ± $939 for balloon spacer vs $6,315 ± $627 for PR). PR was associated with a positive incremental net monetary benefit of $1,802 (95% confidence interval $1,653-$1,951) over balloon spacer at the $50,000/QALY willingness-to-pay threshold. CONCLUSIONS: Compared with PR, the balloon spacer is an "intermediate-value" innovation for treatment of MRCT over a 2-year postoperative period with an ICUR value that falls within the $50,000 to $150,000 willingness-to-pay threshold. LEVEL OF EVIDENCE Level III, retrospective comparative study.