Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis

NCT04588961 | Unknown

• 1 other identifier: WarsawMU/thumb
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpometacarpal Osteoarthritis; Rhizarthrosis; Thumb Osteoarthritis

Keywords

Thumb; Osteoarthritis; Trapeziectomy; Alloplasty; Biomechanics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)

  at baseline, 6 weeks and 6 months postoperatively

• Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire

  at baseline, 6 weeks and 6 months postoperatively

• Changes in patients reported outcomes - SF-36 (Short Form 36)

  at baseline, 6 weeks and 6 months postoperatively

• Changes in patients reported outcome measures - VAS (Visual Analogue Score)

  at baseline, 6 weeks and 6 months postoperatively

• Changes in carpometacarpal, carpophalangeal and wrist range of motion

  at baseline, 6 weeks and 6 months postoperatively

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis

Procedure: Trapeziectomy with suspensionplasty

Study group

ACTIVE COMPARATOR

Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis

Procedure: Joint alloplasty

Interventions

Trapeziectomy with suspensionplasty PROCEDURE

Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon

Control group

Joint alloplasty PROCEDURE

Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis

Also known as: Joint replacement

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-984, Poland

Location

Related Publications (19)

• 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.

  PMID: 16322609 BACKGROUND

• Deiler S. [Basal joint osteoarthritis of the thumb]. Orthopade. 2019 Apr;48(4):351-366. doi: 10.1007/s00132-019-03707-8. German.

  PMID: 30843103 BACKGROUND

• 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.

  PMID: 29969109 BACKGROUND

• 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.

  PMID: 25702783 BACKGROUND

• Mahoney JD, Meals RA. Trapeziectomy. Hand Clin. 2006 May;22(2):165-9. doi: 10.1016/j.hcl.2006.02.003.

  PMID: 16701128 BACKGROUND

• 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.

  PMID: 27418894 BACKGROUND

• 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.

  PMID: 31876776 BACKGROUND

• 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.

  PMID: 29595674 BACKGROUND

• 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.

  PMID: 28481387 BACKGROUND

• 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.

  PMID: 30107277 BACKGROUND

• 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.

  PMID: 32162998 BACKGROUND

• 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.

  PMID: 32349588 BACKGROUND

• 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.

  PMID: 32280181 BACKGROUND

• 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.

  PMID: 31733980 BACKGROUND

• 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.

  PMID: 25143644 BACKGROUND

• 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.

  PMID: 28853432 BACKGROUND

• 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.

  PMID: 30099114 BACKGROUND

• 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.

  PMID: 28836994 BACKGROUND

• 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.

  PMID: 27757230 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Piotr Stępiński, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Stępiński, MD

CONTACT

607 190 402; piotr.stepinski01@gmail.com

Bartosz M. Maciąg, MD

CONTACT

881 568 144; bartosz.maciag94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients would be assigned randomly to 2 different groups

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 19, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2024
• Last Updated: January 6, 2021

Record last verified: 2020-09

Locations

PL (1)