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Open Access 01-12-2024 | Trapeziectomy | Study protocol

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

Authors: Serafín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan, Eduardo Sánchez-Iriso

Published in: Trials | Issue 1/2024

Abstract

Background

Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction.

Methods

A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial’s eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests.

A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial’s primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider’s and society perspective using direct and indirect medical costs.

Discussion

This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA.

Trial registration

ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.

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Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, et al. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011;70(9):1581–6. Available from: http://ard.bmj.com/cgi/doi/10.1136/ard.2011.150078.CrossRefPubMed

Swigart CR, Eaton RG, Glickel SZ, Johnson C. Splinting in the treatment of arthritis of the first carpometacarpal joint. J Hand Surg Am. 1999;24(1):86–91. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502399837770.CrossRefPubMed

Gay A-M, Cerlier A, Iniesta A, Legré R. Surgery for trapeziometacarpal osteoarthritis. Hand Surg Rehabil. 2016;35(4):238–49. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2468122916300615.CrossRefPubMed

Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2017 Apr 3;2015(4). Available from: http://doi.wiley.com/10.1002/14651858.CD004631.pub5.

Parker WL. Evidence-Based Medicine: Thumb Carpometacarpal Arthroplasty. Plast Reconstr Surg. 2013;132(6):1706–19. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00006534-201312000-00051.CrossRefPubMed

Vermeulen GM, Slijper H, Feitz R, Hovius SER, Moojen TM, Selles RW. Surgical Management of Primary Thumb Carpometacarpal Osteoarthritis: A Systematic Review. J Hand Surg Am. 2011;36(1):157–69. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502310013298.CrossRefPubMed

Copeland A, Gallo L, Weber C, Moltaji S, Gallo M, Murphy J, et al. Reporting outcomes and outcome measures in thumb carpometacarpal joint osteoarthritis: a systematic review. J Hand Surg Am. 2020;1–11. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502320303385.

Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004;114(2):421–32. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00006534-200408000-00019.CrossRefPubMed

Wolf JM, Delaronde S. Current Trends in Nonoperative and Operative Treatment of Trapeziometacarpal Osteoarthritis: A Survey of US Hand Surgeons. J Hand Surg Am. 2012;37(1):77–82. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502311012883.CrossRefPubMed

10.

Aliu O, Davis MM, DeMonner S, Chung KC. The Influence of Evidence in the Surgical Treatment of Thumb Basilar Joint Arthritis. Plast Reconstr Surg. 2013;131(4):816–28. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00006534-201304000-00028.CrossRefPubMedPubMedCentral

11.

Deutch Z, Niedermeier SR, Awan HM. Surgeon preference, influence, and treatment of thumb carpometacarpal arthritis. Hand. 2018;13(4):403–11.CrossRefPubMed

12.

Brunton LM, Wilgis EFS. A Survey to Determine Current Practice Patterns in the Surgical Treatment of Advanced Thumb Carpometacarpal Osteoarthrosis. HAND. 2010;5(4):415–22. Available from: http://journals.sagepub.com/doi/10.1007/s11552-010-9275-7.CrossRefPubMedPubMedCentral

13.

Salem H, Davis TRC. Six year outcome excision of the trapezium for trapeziometacarpal joint osteoarthritis: is it improved by ligament reconstruction and temporary Kirschner wire insertion? J Hand Surg (European Vol). 2012Mar 24;37(3):211–9. Available from: http://journals.sagepub.com/doi/10.1177/1753193411414516.CrossRef

14.

Ulrich-Vinther M, Puggaard H, Lange B. Prospective 1-year follow-up study comparing joint prosthesis with tendon interposition arthroplasty in treatment of trapeziometacarpal osteoarthritis. J Hand Surg Am. 2008;33(8):1369–77. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502308004012.CrossRefPubMed

15.

Vadstrup LS, Schou L, Boeckstyns MEH. Basal joint osteoarthritis of the thumb treated with weilby arthroplasty: a prospective study on the early postoperative course of 106 consecutive cases. J Hand Surg (European Vol). 2009;34(4):503–5. Available from: http://journals.sagepub.com/doi/10.1177/1753193409105084.CrossRef

16.

Giddins G. Editorial. J Hand Surg (European Vol). 2015;40(3):233–233. Available from: http://journals.sagepub.com/doi/10.1177/1753193415570814.CrossRef

17.

Huang K, Hollevoet N, Giddins G. Thumb carpometacarpal joint total arthroplasty: a systematic review. J Hand Surg (European Vol). 2015May 19;40(4):338–50. Available from: http://journals.sagepub.com/doi/10.1177/1753193414563243.CrossRef

18.

Cebrian-Gomez R, Lizaur-Utrilla A, Sebastia-Forcada E, Lopez-Prats FA. Outcomes of cementless joint prosthesis versus tendon interposition for trapeziometacarpal osteoarthritis: a prospective study. J Hand Surg (European Vol). 2019;44(2):151–8. Available from: http://journals.sagepub.com/doi/https://doi.org/10.1177/1753193418787151.CrossRef

19.

Martin-Ferrero M, Simón-Pérez C, Coco-Martín MB, Vega-Castrillo A, Aguado-Hernández H, Mayo-Iscar A. Trapeziometacarpal total joint arthroplasty for osteoarthritis: 199 patients with a minimum of 10 years follow-up. J Hand Surg Eur. 2020;45(5):443–51.CrossRef

20.

Martin-Ferrero M. Ten-year long-term results of total joint arthroplasties with ARPE ® implant in the treatment of trapeziometacarpal osteoarthritis. J Hand Surg (European Vol). 2014;39(8):826–32. Available from: http://journals.sagepub.com/doi/10.1177/1753193413516244.CrossRef

21.

Toffoli A, Teissier J. MAÏA Trapeziometacarpal joint arthroplasty: clinical and radiological outcomes of 80 patients with more than 6 years of follow-up. J Hand Surg Am. 2017;42:838.e1–838.e8.CrossRefPubMed

22.

Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672–7.CrossRefPubMed

23.

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. Available from: https://www.bmj.com/lookup/doi/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

24.

Spaans AJ, van Minnen LP, Kon M, Schuurman AH, Schreuders AR (Ton), Vermeulen GM. Conservative treatment of thumb base osteoarthritis: a systematic review. J Hand Surg Am. 2015;40(1):16–21.e6. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502314014336.CrossRefPubMed

25.

Vissers G, Goorens CK, Vanmierlo B, Bonte F, Mermuys K, Fils JF, et al. Ivory arthroplasty for trapeziometacarpal osteoarthritis: 10-year follow-up. J Hand Surg Eur. 2019;44(2):138–45. Available from: http://journals.sagepub.com/doi/10.1177/1753193418797890.CrossRef

26.

Goubau JF, Goorens CK, Van Hoonacker P, Berghs B, Kerckhove D, Scheerlinck T. Clinical and radiological outcomes of the Ivory arthroplasty for trapeziometacarpal joint osteoarthritis with a minimum of 5 years of follow-up: A prospective single-centre cohort study. J Hand Surg Eur. 2013;38:866–74.CrossRef

27.

Model Z, Liu AY, Kang L, Wolfe SW, Burket JC, Lee SK. Evaluation of Physical Examination Tests for Thumb Basal Joint Osteoarthritis. HAND. 2016;11(1):108–12. Available from: http://journals.sagepub.com/doi/10.1177/1558944715616951.CrossRefPubMedPubMedCentral

28.

Sela Y, Seftchick J, Wang WL, Baratz ME. The diagnostic clinical value of thumb metacarpal grind, pressure-shear, flexion, and extension tests for carpometacarpal osteoarthritis. J Hand Ther. 2019;32(1):35–40. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0894113017301400.CrossRefPubMed

29.

Kennedy CD, Manske MC, Huang JI. Classifications in Brief: The Eaton-Littler Classification of Thumb Carpometacarpal Joint Arthrosis. Clin Orthop Relat Res. 2016;474(12):2729–33.CrossRefPubMedPubMedCentral

30.

Eaton RG, Lane LB, Littler JW, Keyser JJ. Ligament reconstruction for the painful thumb carpometacarpal joint: a long-term assessment. J Hand Surg Am. 1984;9(5):692–9. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502384800155.CrossRefPubMed

31.

O’Callaghan CA. OxMaR: Open source free software for online minimization and randomization for clinical trials. Añel JA, editor. PLoS One. 2014;9(10):e110761. Available from: https://dx.plos.org/10.1371/journal.pone.0110761. [cited 2023 May 22]CrossRefPubMedPubMedCentral

32.

Harenberg PS, Jakubietz MG, Jakubietz RG, Schmidt K, Meffert RH. Treatment of osteoarthritis of the first carpometacarpal joint by resection–suspension–interposition arthoplasty using the split abductor pollicis longus tendon. Oper Orthop Traumatol. 2013;25(1):95–103. Available from: http://link.springer.com/10.1007/s00064-011-0082-2.CrossRefPubMed

33.

Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1–2):9–19.CrossRefPubMed

34.

Rosales RS, De La Lastra ID, McCabe S, Ortega Martinez JI, Hidalgo YM. The relative responsiveness and construct validity of the spanish version of the dash instrument for outcomes assessment in open carpal tunnel release. J Hand Surg (European Vol). 2009;34(1):72–5. Available from: http://journals.sagepub.com/doi/10.1177/1753193408094156.CrossRef

35.

Beaton DE, Wright JG, Katz JN. Development of the QuickDASH. J Bone Jt Surg. 2005;87(5):1038–46. Available from: http://journals.lww.com/00004623-200505000-00015.

36.

Rosales RS, García-Gutierrez R, Reboso-Morales L, Atroshi I. The Spanish version of the Patient-Rated Wrist Evaluation outcome measure: Cross-cultural adaptation process, reliability, measurement error and construct validity. Health Qual Life Outcomes. 2017;15(1):1–9.CrossRef

37.

Belcher HJCR, Smith H. Extended dynamometry: reference values. J Hand Surg Eur. 2019;44(2):196–202.CrossRef

38.

McQuillan TJ, Kenney D, Crisco JJ, Weiss AP, Ladd AL. Weaker Functional Pinch Strength Is Associated With Early Thumb Carpometacarpal Osteoarthritis. Clin Orthop Relat Res. 2016;474(2):557–61.CrossRefPubMed

39.

Marti C, Hensler S, Herren DB, Niedermann K, Marks M. Measurement properties of the EuroQoL EQ-5D-5L to assess quality of life in patients undergoing carpal tunnel release. J Hand Surg Eur. 2016;41(9):957–62.CrossRef

40.

Royston P, White IR. Journal of Statistical Software Multiple Imputation by Chained Equations (MICE): Implementation in Stata. J Stat Softw. 2011;45(4):1–20. Available from: http://www.jstatsoft.org/.CrossRef

41.

Montesino-Semper MF, Jimenez-Calvo JM, Cabases JM, Sanchez-Iriso E, Hualde-Alfaro A, García-García D. Cost-effectiveness analysis of the surgical treatment of female urinary incontinence using slings and meshes. Eur J Obstet Gynecol Reprod Biol. 2013Nov;171(1):180–6. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0301211513004302.CrossRefPubMed

42.

Grossman M. The demand for health: a theorical and empirical investigation. New York. Columbia University Press; 1972.

43.

Krol M, Brouwer W. How to estimate productivity costs in economic evaluations. Pharmacoeconomics. 2014;32(4):335–44. Available from: http://link.springer.com/10.1007/s40273-014-0132-3.CrossRefPubMed

44.

Liljas B. How to calculate indirect costs in economic evaluations. Pharmacoeconomics. 1998;13(1):1–7. Available from: http://link.springer.com/10.2165/00019053-199813010-00001.CrossRefPubMed

45.

Oliva J, Rodríguez-sánchez B, Peña- LM, Aranda-reneo I, López-bastida J, Hidalgo-vega Á, et al. Revising the methodological aspects applied to the identification , measurement and valuation of social costs in economic evaluations. Technical Report. Improved methods and actionable tools for enhancing HTA. In: Mimeo. 2021. p. 0–160.

46.

Fenwick E, Claxton K, Sculpher M. Representing uncertainty: The role of cost-effectiveness acceptability curves. Health Econ. 2001;10(8):779–87.CrossRefPubMed

47.

Yuan F, Aliu O, Chung KC, Mahmoudi E. Evidence-Based Practice in the Surgical Treatment of Thumb Carpometacarpal Joint Arthritis. J Hand Surg Am. 2017;42(2):104–112.e1. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0363502316311091.CrossRefPubMedPubMedCentral

48.

49.

Bricout M, Rezzouk J. Complications and failures of the trapeziometacarpal Maia® prosthesis: A series of 156 cases. Hand Surg Rehabil. 2016;35(3):190–8. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2468122916300287.CrossRefPubMed

50.

Marks M, Vliet Vlieland TPM, Audigé L, Herren DB, Nelissen RGHH, van den Hout WB. Healthcare costs and loss of productivity in patients with trapeziometacarpal osteoarthritis. J Hand Surg (European Vol). 2015;40(9):927–34. Available from: http://journals.sagepub.com/doi/10.1177/1753193414568293.CrossRef

Title: Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial
Authors: Serafín Lirola-Palmero
Guillem Salva-Coll
Aina María Yáñez-Juan
Eduardo Sánchez-Iriso
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Trapeziectomy
Trapeziectomy
Osteoarthrosis
Osteoarthrosis
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-08057-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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