Predictive Model for 1-Year Pain and Function Outcomes After Thumb Joint Surgery in Osteoarthritic Patients

NCT06740851 | Active Not Recruiting

• 1 other identifier: 2019-02096
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a predictive model to help doctors better understand expected outcomes one year after thumb joint surgery for osteoarthritis. By analyzing clinical and patient-reported data from individuals who underwent surgery with the Touch® implant, the study seeks to predict pain levels and hand function 1-year after surgery. This information can support shared decision-making, set realistic expectations, and improve personalized treatment planning.

Conditions

Osteoarthritis; Thumb Arthritis; Arthroplasty of the MCP Joint

Keywords

prediction; xgboost; thumb arthroplasty; osteoarthritis; pain; function

Outcome Measures

Primary Outcomes (2)

• Pain During Activities at 1-Year Post-Surgery

  Pain during activities will be measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (maximum pain). Participants rate the level of pain experienced during typical daily activities.

  1 year after surgery

• Hand Function at 1-Year Post-Surgery

  Hand function will be assessed using the brief Michigan Hand Outcomes Questionnaire (bMHQ), which evaluates hand performance in various activities. Scores range from 0 to 100, with higher scores indicating better function.

  1 year after surgery

Study Arms (1)

Touch® patients

Patients who were treated with a primary trapeziometacarpal joint (TMJ) arthroplasty using the Touch® prosthesis for TMJ OA in our single-center prospective registry. Patients had usually received treatments with splints, hand therapy and 1-3 steroid injections before undergoing surgery. Specific indications for primary TMJ implant arthroplasty included good trapezial bone stock without cysts, a trapezial height of at least 8 mm, no clinically relevant scaphotrapezoidal OA and no severe instability of the metacarpophalangeal joint.

Procedure: Touch® Trapeziometacarpal Joint Arthroplasty

Interventions

Touch® Trapeziometacarpal Joint Arthroplasty PROCEDURE

The intervention involves primary trapeziometacarpal joint (TMJ) arthroplasty using the Touch® prosthesis, a dual-mobility implant designed for the treatment of osteoarthritis in the thumb.

Also known as: Primary Trapeziometacarpal Joint Replacement, Thumb Joint Replacement with Touch® Implant

Touch® patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from a single-center prospective registry of patients treated at a specialized orthopedic hospital in Zurich, Switzerland. The population consists of individuals diagnosed with primary trapeziometacarpal joint (TMJ) osteoarthritis who underwent primary TMJ arthroplasty using the Touch® prosthesis. This population represents a mix of patients with varying severities of TMJ osteoarthritis who had failed conservative treatments such as splints, hand therapy, or corticosteroid injections before undergoing surgery.

You may qualify if:

• Patients who were treated with a primary TMJ arthroplasty using the Touch® prosthesis for TMJ OA in our single-center prospective registry.
• Patients who had completed their 1-year follow-up questionnaire

You may not qualify if:

• Revision surgery,
• Not treated for primary osteoarthritis (i.e., secondary osteoarthritis or rheumatoid arthritis or other),
• Did not sign the consent form

Sponsors & Collaborators

• Michael Oyewale: lead
• Erasmus Medical Center: collaborator
• University of Rotterdam, The Netherlands: collaborator

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (12)

• Hamasaki T, Harris PG, Bureau NJ, Gaudreault N, Ziegler D, Choiniere M. Efficacy of Surgical Interventions for Trapeziometacarpal (Thumb Base) Osteoarthritis: A Systematic Review. J Hand Surg Glob Online. 2021 Mar 23;3(3):139-148. doi: 10.1016/j.jhsg.2021.02.003. eCollection 2021 May.

  PMID: 35415551 BACKGROUND

• Vermeulen GM, Slijper H, Feitz R, Hovius SE, Moojen TM, Selles RW. Surgical management of primary thumb carpometacarpal osteoarthritis: a systematic review. J Hand Surg Am. 2011 Jan;36(1):157-69. doi: 10.1016/j.jhsa.2010.10.028.

  PMID: 21193136 BACKGROUND

• Falkner F, Tumkaya AM, Thomas B, Panzram B, Bickert B, Harhaus L. Dual mobility prosthesis for trapeziometacarpal osteoarthritis: results from a prospective study of 55 prostheses. J Hand Surg Eur Vol. 2023 Jun;48(6):566-574. doi: 10.1177/17531934231156280. Epub 2023 Feb 28.

  PMID: 36855785 BACKGROUND

• Herren DB, Marks M, Neumeister S, Schindele S. Low complication rate and high implant survival at 2 years after Touch(R) trapeziometacarpal joint arthroplasty. J Hand Surg Eur Vol. 2023 Oct;48(9):877-883. doi: 10.1177/17531934231179581. Epub 2023 Jun 13.

  PMID: 37310049 BACKGROUND

• Bertozzi L, Valdes K, Vanti C, Negrini S, Pillastrini P, Villafane JH. Investigation of the effect of conservative interventions in thumb carpometacarpal osteoarthritis: systematic review and meta-analysis. Disabil Rehabil. 2015;37(22):2025-43. doi: 10.3109/09638288.2014.996299. Epub 2015 Jan 5.

  PMID: 25559974 BACKGROUND

• Esteban Lopez LMJ, Hoogendam L, Vermeulen GM, Tsehaie J, Slijper HP, Selles RW, Wouters RM; The Hand-Wrist Study Group. Long-Term Outcomes of Nonsurgical Treatment of Thumb Carpometacarpal Osteoarthritis: A Cohort Study. J Bone Joint Surg Am. 2023 Dec 6;105(23):1837-1845. doi: 10.2106/JBJS.22.01116. Epub 2023 Oct 30.

  PMID: 37903291 BACKGROUND

• Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M. Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis. 2010 Mar;69(3):585-7. doi: 10.1136/ard.2009.104562. Epub 2010 Feb 2.

  PMID: 20124359 BACKGROUND

• Gehrmann SV, Tang J, Li ZM, Goitz RJ, Windolf J, Kaufmann RA. Motion deficit of the thumb in CMC joint arthritis. J Hand Surg Am. 2010 Sep;35(9):1449-53. doi: 10.1016/j.jhsa.2010.05.026.

  PMID: 20807622 BACKGROUND

• Bakri K, Moran SL. Thumb carpometacarpal arthritis. Plast Reconstr Surg. 2015 Feb;135(2):508-520. doi: 10.1097/PRS.0000000000000916.

  PMID: 25626796 BACKGROUND

• van der Oest MJW, Duraku LS, Andrinopoulou ER, Wouters RM, Bierma-Zeinstra SMA, Selles RW, Zuidam JM. The prevalence of radiographic thumb base osteoarthritis: a meta-analysis. Osteoarthritis Cartilage. 2021 Jun;29(6):785-792. doi: 10.1016/j.joca.2021.03.004. Epub 2021 Mar 17.

  PMID: 33744429 BACKGROUND

• Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.

  PMID: 21622766 BACKGROUND

• Kloppenburg M, van Beest S, Kroon FPB. Thumb base osteoarthritis: A hand osteoarthritis subset requiring a distinct approach. Best Pract Res Clin Rheumatol. 2017 Oct;31(5):649-660. doi: 10.1016/j.berh.2018.08.007. Epub 2018 Sep 26.

  PMID: 30509411 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Touch

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: February 8, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)