ClinicalTrials.Veeva

Menu

Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

I

Isala

Status

Unknown

Conditions

Trapeziometacarpal Osteoarthritis
Thumb Carpometacarpal Osteoarthritis

Treatments

Procedure: Trapeziectomy
Procedure: Trapeziectomy with LRTI

Study type

Interventional

Funder types

Other

Identifiers

NCT02204995
NL48197.075.14 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

62 estimated patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Trapeziectomy with LRTI
Active Comparator group
Description:
Trapeziectomy with Ligament Reconstruction and Tendon Interposition
Treatment:
Procedure: Trapeziectomy with LRTI
Trapeziectomy
Active Comparator group
Description:
Trapeziectomy
Treatment:
Procedure: Trapeziectomy

Trial contacts and locations

1

Loading...

Central trial contact

Ramon P. de Wildt, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems