Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

NCT02204995 | Unknown

• 1 other identifier: NL48197.075.14
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Trapeziometacarpal Osteoarthritis; Thumb Carpometacarpal Osteoarthritis

Keywords

Osteoarthritis; Thumb; LRTI; Trapeziectomy

Outcome Measures

Primary Outcomes (1)

• Michigan Hand Outcomes Questionnaire (MHOQ)

  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)?

  1 year after surgery

Secondary Outcomes (7)

• Michigan Hand Outcomes Questionnaire (MHOQ)

  5 years after surgery

• Michigan Hand Outcomes Questionnaire (MHOQ)

  1 and 5 years after surgery

• Disabilities of Arm Shoulder and Hand (DASH)

  1 and 5 years after surgery

• Grip strength

  1 and 5 years after surgery

• Thumb mobility

  1 and 5 years after surgery

Study Arms (2)

Trapeziectomy with LRTI

ACTIVE COMPARATOR

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

Procedure: Trapeziectomy with LRTI

Trapeziectomy

ACTIVE COMPARATOR

Trapeziectomy

Procedure: Trapeziectomy

Interventions

Trapeziectomy with LRTI PROCEDURE

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

Trapeziectomy with LRTI

Trapeziectomy PROCEDURE

Trapeziectomy

Trapeziectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• years of age or more
• Symptomatic trapeziometacarpal osteoarthritis
• Eaton \& Glickel stage 4

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Hospital

Zwolle, Overijssel, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jeroen H. van Uchelen, MD

  Isala

  STUDY CHAIR

Central Study Contacts

Ramon P. de Wildt, MD

CONTACT

r.p.de.wildt@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2021
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

NL (1)