Thumb Osteoarthritis Clinical Trial
Official title:
Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists - 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: - patient do not agree to take a part into study - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Othopedics and Rehabilitation, Medical University of Warsaw | Warszawa | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
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. — View Citation
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. — View Citation
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. — View Citation
Deiler S. [Basal joint osteoarthritis of the thumb]. Orthopade. 2019 Apr;48(4):351-366. doi: 10.1007/s00132-019-03707-8. German. — View Citation
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. — View Citation
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. — View Citation
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. eCollection 2016. Review. — View Citation
Mahoney JD, Meals RA. Trapeziectomy. Hand Clin. 2006 May;22(2):165-9. Review. — View Citation
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. — View Citation
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. — View Citation
Robles-Molina MJ, López-Caba F, Gómez-Sánchez RC, Cárdenas-Grande E, Pajares-López M, Hernández-Cortés 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. — View Citation
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 Aug 24;15(1):169. doi: 10.1186/s12955-017-0745-2. — View Citation
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. — View Citation
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. — View Citation
Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-8. — View Citation
Wajngarten D, Campos JÁDB, 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. Review. — View Citation
Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;(2):CD004631. doi: 10.1002/14651858.CD004631.pub4. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 03;4:CD004631. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand) | To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation) | To measure wrist pain and disability in activities of daily living. Results range from 0 to 50, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire | To explore differences in higher levels of activity at work and social participation. Results range from 0 to 100, with higher scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in patients reported outcomes - SF-36 (Short Form 36) | To explore differences in quality of life. Results range from 0 to 100, with higher scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in patients reported outcome measures - VAS (Visual Analogue Score) | To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in carpometacarpal, carpophalangeal and wrist range of motion | To explore differences in range of motion. This parameter will be measured with goniometer in flexion, extension, adduction and abduction in all thumb joints. Outcomes would be numers of degrees ranging from 0-360, with higher number corresponding with better outcomes | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Changes in usage of painkillers | To asses evolution of post-operative thumb pain. Dosage, frequency of utilisation and type of medicines will be measured in self-designed questionnaire, with lower dosage, lower frequency and less powerful medicines corresponding with better results | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Operation related complications | To count and asses all complications that may occur during surgery and in postoperative period | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Arthroplasty revision surgeries | To count and asses the reason of all revision surgeries that may occur during postoperative period | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Biomechanical 3D motion analysis | Movements in whole range are measured using 3D motion analysis, using a special software. With more physiological movement patterns corresponding with better results | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Radiological outcome on x-rays | To asses any changes in alignment of implants with would be measured with degrees (angles) with more degrees of change after operation corresponding with worse outcome | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | Muscle strength outcomes | Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC) | at baseline, 6 weeks and 6 months postoperatively | |
Secondary | EMG measured bioelectrical potentials | Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture | at baseline, 6 weeks and 6 months postoperatively |
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