Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Not Applicable

• Conditions: Thumb Carpometacarpal Osteoarthritis; Trapeziometacarpal Osteoarthritis
• Interventions: Procedure: Trapeziectomy; Procedure: Total Joint Arthroplasty

• Registration Number: NCT02204488
• Lead Sponsor: Isala

Brief Summary

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.

We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Study Start: 2014-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05
• Primary Completion: 2017-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Women.
• 40 years of age or more.
• Symptomatic trapeziometacarpal osteoarthritis.
• Eaton & Glickel stage 2 and 3.

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Exclusion Criteria

• An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
• Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
• Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
• Symptomatic carpal tunnel syndrome in same hand.
• Symptomatic Quervain's tenosynovitis in same hand.
• Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
• Insufficient knowledge of Dutch language.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trapeziectomy	Trapeziectomy	Trapeziectomy
Total Joint Arthroplasty	Total Joint Arthroplasty	Total Joint Arthroplasty

Primary Outcome Measures

Name	Time	Method
Michigan Hand Outcomes Questionnaire (MHOQ)	1 year after surgery	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?

Secondary Outcome Measures

Name	Time	Method
Disabilities of Arm Shoulder and Hand (DASH)	1 and 5 years after surgery	Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
Thumb mobility	1 and 5 years after surgery	Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Michigan Hand Outcomes Questionnaire (MHOQ)	1 and 5 years after surgery	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Complications	1 and 5 years after surgery	Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Grip strength	1 and 5 years after surgery	Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Return to work	1 and 5 years after surgery	Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?

Trial Locations

Locations (1)

Isala Hospital; 🇳🇱 Zwolle, Overijssel, Netherlands