Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial
Sponsor study identifier
Secondary identifiers
REGISTRY · METC Isala
interventional
62
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2014
Actual (reported)July 30, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Total Joint Arthroplasty
Trapeziectomy
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
Trapeziectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Isala Hospital
Zwolle, Overijssel, Netherlands
Jeroen H. van Uchelen, MD
Isala
First Submitted
July 29, 2014
First Posted
July 30, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 5, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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