Assessing New Technologies in Surgery: Case Example of Acute Primary Repair of the Thumb Ulnar Collateral Ligament.

PURPOSE: Health technology assessment provides a means to assess the technical properties, safety, efficacy, cost-effectiveness, and ethical/legal/social impact of a novel technology. An important component of health technology assessment is the cost-effectiveness analysis (CEA), which can be performed using model-based CEA. This study used the CEA model to compare the cost-effectiveness of a novel ligament augmentation device with the standard technique for primary repair of complete ulnar collateral ligament (UCL) tears. METHODS: A model was developed for complete UCL tear requiring acute surgical repair, comparing the cost-effectiveness of standard technique primary repair and repair using a ligament augmentation device from a societal perspective. Primary outcomes included quality-adjusted life years (QALYs), cost, net monetary benefit (NMB) and incremental NMB. A cost-effectiveness threshold of CAD $50,000/QALY was used to compare the 2 techniques. Sensitivity analyses were conducted to assess the parameter uncertainty, specifically the impact of device cost, time off work, probability of complication, and postoperative outcome. RESULTS: The NMB for the standard technique was CAD $42,598, and the NMB for repair using the ligament augmentation device was CAD $41,818. The standard technique was the preferred strategy for primary repair of complete UCL tears. One-way sensitivity analyses demonstrated that the ligament augmentation device became cost-effective if individuals return to work in <18 days (base case 23 days). The device was also favored when the cost was less than CAD $50 and the difference in time to return to work was at least 1 day. CONCLUSIONS: Our model demonstrates that there may be significant costs associated with the introduction of novel health technologies, and certain conditions, such as an earlier return to work, must be met for some devices to be a cost-effective option. This study provides an example of how model-based CEA is a useful tool to assess the cost-effectiveness of a novel device. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/Decision Analysis II.

Comparative Cost-Effectiveness of Cranioplasty Implants.

PURPOSE: The aim of this study was to compare operative duration and total hospital costs incurred for patients undergoing elective cranioplasty with a variety of materials, including manually shaped autogenous bone graft and titanium mesh, custom patient-specific titanium mesh, polymethyl methacrylate (PMMA) acrylic, and polyetheretherketone (PEEK) implants. METHODS: A single-centre retrospective chart review was used. Patient demographics, defect characteristics, total operative time, and length of hospital stay were obtained. Total costs were sourced from Sunnybrook and standardized to the 2014 to 2015 year. Bivariate and age-controlled multivariate analyses were performed with (n = 119) and without (n = 101) outliers. RESULTS: When outliers were removed, an age-controlled analysis revealed that autogenous implants resulted in an operative time of 178 ± 37 minutes longer than manually shaped titanium implants (P < .01). The average cost of cranioplasty was CAD$18 335 ± CAD$10 265 for manually shaped titanium implants, CAD$31 956 ± CAD$31 206 for custom patient-specific titanium implants, CAD$20 786 ± CAD$13 075 for PMMA, CAD$14 291 ± CAD$5562 for autogenous implants, and CAD$27 379 ± CAD$4945 for PEEK implants (P = .013). When outliers were removed, cranioplasty with PMMA and PEEK incurred greater costs, CAD$4442 ± CAD$2100 and CAD$13 372 ± CAD$2728, respectively, more than manually shaped titanium implants (P < .01). CONCLUSIONS: Manually shaped titanium mesh is the most cost-effective implant choice for small cranial defects. Large unknown defects and frontal paranasal sinus defects are most effectively treated with autogenous bone or titanium mesh. Despite prolonged operative duration and inpatient admission, total costs were not significantly increased. Both PMMA and PEEK implants were significantly more costly, which may be a result of higher complications necessitating reoperation.

OBJECTIF: La présente étude visait à comparer la durée de l'opération et les coûts hospitaliers totaux engagés pour les patients qui subissaient une cranioplastie non urgente faisant appel à divers matériaux : greffon osseux autologue et treillis de titane façonnés à la main, implant PMMA et implant PEEK. MÉTHODOLOGIE: Les chercheurs ont réalisé une analyse rétrospective monocentrique des dossiers. Ils ont colligé les renseignements démographiques sur les patients, les caractéristiques de l'anomalie, la durée totale de l'opération et la durée du séjour hospitalier. Ils ont extrait les coûts totaux de Sunnybrook et les ont standardisés pour l'année 2014-2015. Ils ont effectué des analyses bivariées et multivariées contrôlées selon l'âge en incluant (n=119) et en excluant (n=101) les valeurs aberrantes. RÉSULTATS: Après l'élimination des valeurs aberrantes, une analyse contrôlée selon l'âge a révélé que les implants autologues s'associaient à une opération plus longue de 178 ± 37 min que les implants de titane façonnés à la main (p<0,01). Le coût moyen de la cranioplastie s'élevait à 18 335 CAD$ ± 10 265 CAD$ pour les implants de titane façonnés à la main, à 31 956 CAD$ ± 31 206 CAD$ pour les implants de titane adaptés aux patients, à 20 786 CAD$ ± 13 075 CAD$ pour les implants en PMMA, à 14 291 CAD$ ± 5 562 CAD$ pour les implants autologues et à 27 379 CAD$ ± 4 945 CAD$ pour les implants en PEEK (p=0,013). Une fois les valeurs aberrantes éliminées, la cranioplastie par PMMA ou PEEK étaient les plus coûteuses, à 4 442 CAD$ ± 2 100 CAD$ et 13 372 CAD$ ± 2 728 CAD$ de plus que les implants de titane façonnés à la main (p<0,01). CONCLUSIONS: Les treillis de titane façonnés à la main présentent le meilleur rapport coût-efficacité en cas d'anomalies crâniennes bénignes. Le traitement des graves anomalies d'origine inconnue et des anomalies des sinus paranasaux frontaux les plus efficaces sont l'os autologue ou le treillis de titane. Malgré une opération et un séjour hospitalier prolongés, les coûts totaux n'augmentaient pas de manière significative. Les implants de PMMA et de PEEK étaient considérablement plus cher, peut-être à cause du plus fort taux de complications donnant lieu à une réopération.