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

NCT02204488 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-09-05

No results posted yet for this study

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.

Conditions

  • Trapeziometacarpal Osteoarthritis
  • Thumb Carpometacarpal Osteoarthritis

Interventions

PROCEDURE

Total Joint Arthroplasty

Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France

PROCEDURE

Trapeziectomy

Trapeziectomy

Sponsors & Collaborators

  • Isala

    lead OTHER

Principal Investigators

  • Jeroen H. van Uchelen, MD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2021-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02204488 on ClinicalTrials.gov