Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis
NCT ID: NCT04588961
Last Updated: 2021-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-06-01
2024-12-31
Brief Summary
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Detailed Description
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In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis
Trapeziectomy with suspensionplasty
Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
Study group
Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis
Joint alloplasty
Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
Interventions
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Trapeziectomy with suspensionplasty
Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
Joint alloplasty
Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptoms that do not respond to non-operative treatment for 8 weeks
* no counterindications for anaesthesia
* signed agreement for taking a part into trial
Exclusion Criteria
* problems with communication with patient
* unstable cardiac disease
* reoperations
* previous surgical interventions in hand
* neuro-muscular diseases
* rheumatological background of disease
* diagnosed cervical spine disorders
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Piotr Stępiński, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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References
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Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.
Deiler S. [Basal joint osteoarthritis of the thumb]. Orthopade. 2019 Apr;48(4):351-366. doi: 10.1007/s00132-019-03707-8. German.
Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374.
Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.
Mahoney JD, Meals RA. Trapeziectomy. Hand Clin. 2006 May;22(2):165-9. doi: 10.1016/j.hcl.2006.02.003.
Naram A, Lyons K, Rothkopf DM, Calkins ER, Breen T, Jones M, Shufflebarger JV. Increased Complications in Trapeziectomy With Ligament Reconstruction and Tendon Interposition Compared With Trapeziectomy Alone. Hand (N Y). 2016 Mar;11(1):78-82. doi: 10.1177/1558944715617215. Epub 2016 Jan 14.
Sivakumar BS, Graham DJ. APL Lasso Suspensionplasty for Trapeziectomy. Tech Hand Up Extrem Surg. 2020 Sep;24(3):108-113. doi: 10.1097/BTH.0000000000000276.
Wang T, Zhao G, Rui YJ, Mi JY. Outcomes of modified trapeziectomy with ligament reconstruction tendon interposition for the treatment of advanced thumb carpometacarpal arthritis: Two-year follow-up. Medicine (Baltimore). 2018 Mar;97(13):e0235. doi: 10.1097/MD.0000000000010235.
Robles-Molina MJ, Lopez-Caba F, Gomez-Sanchez RC, Cardenas-Grande E, Pajares-Lopez M, Hernandez-Cortes P. Trapeziectomy With Ligament Reconstruction and Tendon Interposition Versus a Trapeziometacarpal Prosthesis for the Treatment of Thumb Basal Joint Osteoarthritis. Orthopedics. 2017 Jul 1;40(4):e681-e686. doi: 10.3928/01477447-20170503-03. Epub 2017 May 8.
Degeorge B, Dagneaux L, Andrin J, Lazerges C, Coulet B, Chammas M. Do trapeziometacarpal prosthesis provide better metacarpophalangeal stability than trapeziectomy and ligamentoplasty? Orthop Traumatol Surg Res. 2018 Nov;104(7):1095-1100. doi: 10.1016/j.otsr.2018.07.008. Epub 2018 Aug 11.
Lane JCE, Rodrigues JN, Furniss D, Burn E, Poulter R, Gardiner MD. Basal thumb osteoarthritis surgery improves health state utility irrespective of technique: a study of UK Hand Registry data. J Hand Surg Eur Vol. 2020 Jun;45(5):436-442. doi: 10.1177/1753193420909753. Epub 2020 Mar 12.
Parker S, Riley N, Dean B; Oxford Upper Limb Collaborative. Management of osteoarthritis at the base of the thumb. Bone Joint J. 2020 May;102-B(5):600-605. doi: 10.1302/0301-620X.102B5.BJJ-2019-1464.R2.
Al-Qattan MM, Al Mohrij SA. Mid-Term Results of Partial Trapeziectomy and Simple FCR Tendon Graft Interposition in a Selected Group of Patients with Thumb Carpometacarpal Joint Arthritis. J Hand Microsurg. 2020 Apr;12(1):43-46. doi: 10.1055/s-0039-1698356. Epub 2019 Nov 22.
Shah DS, Middleton C, Gurdezi S, Horwitz MD, Kedgley AE. The Effect of Surgical Treatments for Trapeziometacarpal Osteoarthritis on Wrist Biomechanics: A Cadaver Study. J Hand Surg Am. 2020 May;45(5):389-398. doi: 10.1016/j.jhsa.2019.10.003. Epub 2019 Nov 14.
Chug M, Williams N, Benn D, Brindley S. Outcome of uncemented trapeziometacarpal prosthesis for treatment of thumb carpometacarpal joint arthritis. Indian J Orthop. 2014 Jul;48(4):394-8. doi: 10.4103/0019-5413.136270.
Wajngarten D, Campos JADB, Garcia PPNS. The Disabilities of the Arm, Shoulder and Hand scale in the evaluation of disability - A literature review. Med Lav. 2017 Aug 28;108(4):314-323. doi: 10.23749/mdl.v108i4.6336.
Kroon FPB, Boersma A, Boonen A, van Beest S, Damman W, van der Heijde D, Rosendaal FR, Kloppenburg M. Performance of the Michigan Hand Outcomes Questionnaire in hand osteoarthritis. Osteoarthritis Cartilage. 2018 Dec;26(12):1627-1635. doi: 10.1016/j.joca.2018.07.018. Epub 2018 Aug 9.
Rosales RS, Garcia-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 Aug 24;15(1):169. doi: 10.1186/s12955-017-0745-2.
Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
Other Identifiers
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WarsawMU/thumb
Identifier Type: -
Identifier Source: org_study_id
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