Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

Not Applicable

• Conditions: Thumb Carpometacarpal Osteoarthritis; Trapeziometacarpal Osteoarthritis
• Interventions: Procedure: Trapeziectomy; Procedure: Trapeziectomy with LRTI

• Registration Number: NCT02204995
• 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. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.

The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• 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 4

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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
Trapeziectomy with LRTI	Trapeziectomy with LRTI	Trapeziectomy with Ligament Reconstruction and Tendon Interposition

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
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)?
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)?
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?
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?
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?
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