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

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ClinicalTrials.gov Identifier: NCT02204488
Recruitment Status : Recruiting
First Posted : July 30, 2014
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Ramon de Wildt, 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. 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.


Condition or disease Intervention/treatment Phase
Trapeziometacarpal Osteoarthritis Thumb Carpometacarpal Osteoarthritis Procedure: Total Joint Arthroplasty Procedure: Trapeziectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Total Joint Arthroplasty
Total Joint Arthroplasty
Procedure: Total Joint Arthroplasty
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France

Active Comparator: Trapeziectomy
Trapeziectomy
Procedure: Trapeziectomy
Trapeziectomy




Primary Outcome Measures :
  1. Michigan Hand Outcomes Questionnaire (MHOQ) [ Time Frame: 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 :
  1. Michigan Hand Outcomes Questionnaire (MHOQ) [ Time Frame: 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 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?

  2. Michigan Hand Outcomes Questionnaire (MHOQ) [ Time Frame: 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)?

  3. Disabilities of Arm Shoulder and Hand (DASH) [ Time Frame: 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)?

  4. Grip strength [ Time Frame: 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?

  5. Thumb mobility [ Time Frame: 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?

  6. Complications [ Time Frame: 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?

  7. Return to work [ Time Frame: 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?



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204488


Contacts
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Contact: Ramon P. de Wildt, MD r.p.de.wildt@isala.nl

Locations
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Netherlands
Isala Hospital Recruiting
Zwolle, Overijssel, Netherlands
Contact: Ramon P. de Wildt, MD       r.p.de.wildt@isala.nl   
Principal Investigator: Ramon P. de Wildt, MD         
Sponsors and Collaborators
Isala
Investigators
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Study Director: Jeroen H. van Uchelen, MD Isala

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Responsible Party: Ramon de Wildt, MD, Isala
ClinicalTrials.gov Identifier: NCT02204488     History of Changes
Other Study ID Numbers: NL47755.075.14
NL47755.075.14 ( Registry Identifier: METC Isala )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Keywords provided by Ramon de Wildt, Isala:
Osteoarthritis
Thumb
Total joint arthroplasty
Trapeziectomy

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases