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

I

Isala

Status

Unknown

Conditions

Trapeziometacarpal Osteoarthritis
Thumb Carpometacarpal Osteoarthritis

Treatments

Procedure: Trapeziectomy
Procedure: Total Joint Arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT02204488
NL47755.075.14 (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. 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.

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 2 and 3.

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

Double Blind

62 participants in 2 patient groups

Total Joint Arthroplasty
Active Comparator group
Description:
Total Joint Arthroplasty
Treatment:
Procedure: Total Joint Arthroplasty
Trapeziectomy
Active Comparator group
Description:
Trapeziectomy
Treatment:
Procedure: Trapeziectomy

Trial contacts and locations

1

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Central trial contact

Ramon P. de Wildt, MD

Data sourced from clinicaltrials.gov

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