Sat., 10/18/08 Upper Extremity, Paper #67, 3:57 pm OTA-2008
Δ Is Surgery for Displaced, Midshaft Clavicle Fractures in Adults Cost-Effective? Results from a Multicenter Randomized Controlled Trial
Adam M. Pearson, MD1 (n); Anna Tosteson, PhD1 (n);
Kenneth J. Koval, MD1 (b-Lippincott; b,c,e-Biomet; b,e-Stryker)
Michael D. McKee, MD2 (a-OTA, Zimmer; b-Biotech; b,e-Stryker);
Robert V. Cantu, MD1 (n); John E. Bell, MD1 (n); Andrew Crapser1 (n); Milena Vicente, RN2 (n);
1Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA;
2St. Michael’s Hospital, Toronto, Ontario, Canada
Purpose: Open reduction and internal fixation (ORIF) of displaced, midshaft clavicle fractures in adults has been shown to improve shoulder function compared to nonoperative treatment. However, it is unclear if the cost of ORIF justifies this relatively small functional benefit. This study evaluates the cost-effectiveness of ORIF compared to nonoperative treatment using data from a multicenter randomized controlled trial (RCT).
Methods: Decision analysis was used to model both short- and long-term outcomes for ORIF and nonoperative treatment of a displaced clavicle fracture in a 33-year-old individual. Base-case model parameters were obtained from a large, multicenter RCT that demonstrated better shoulder function at 1 year with ORIF compared to nonoperative treatment. Costs were based on national average Medicare reimbursements, adjusted to account for the higher reimbursement by private payers. Utilities (ie, impact of complications on quality of life) were determined from RCT participants’ Short Form-6D scores. Nonoperative treatment has been shown to result in functional deficits at 4.4 years, so the benefit of ORIF was assumed to persist for this long in the base case. The duration of benefit was varied from 1 year to permanent in sensitivity analyses. An incremental cost-effectiveness analysis estimated the mean added cost per quality-adjusted life year (QALY) gained for ORIF relative to nonoperative care. Sensitivity analyses were used to determine which parameters reduced the estimated cost per QALY gained to $50,000 (an accepted threshold for cost-effectiveness).
Results: The base-case cost per QALY gained for ORIF was $65,000. Cost-effectiveness improved to $28,150/QALY gained when ORIF’s functional benefit was assumed to be permanent, with cost per QALY gained falling below $50,000 when functional advantage persisted for 9.3 years or more. In other sensitivity analyses, the cost per QALY gained for ORIF fell below $50,000 when ORIF cost less than $10,465 (base-case cost, $13,668) or the long-term utility difference between nonoperative treatment and ORIF was greater than 0.034 (base-case utility difference, 0.014). Short-term disutility associated with fracture healing also affected ORIF’s cost-effectiveness, with the cost per QALY gained for ORIF falling below $50,000 when the utility of an unhealed fracture treated nonoperatively was less than 0.617 (base-case utility, 0.706) or when nonoperative treatment increased the time to union by 20 weeks (base-case difference, 12 weeks).
Conclusion: The cost-effectiveness of ORIF depends on the durability of functional advantage for ORIF compared to nonoperative treatment. When functional benefits persist for more than 9 years, ORIF has favorable value compared with many commonly accepted health interventions. Operative treatment is most appropriate for patients who are intolerant of mild functional deficits and highly value a more rapid return to normal function, especially in a low-cost environment.
Significance: This study highlights the need for a long-term follow-up comparing clavicle ORIF versus nonoperative treatment to determine if the functional benefit associated with surgery persists. The cost-effectiveness of ORIF will remain uncertain until these data become available.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.