NCT01904019|CompletedResults
Comparison of ARPE Prosthesis With the Literature
Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
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Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
Sponsor study identifier
observational
100
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2020
Actual (reported)Study Completion
May 2021
Actual (reported)This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 19, 2013
Actual (reported)July 19, 2013
Actual (reported)October 2020
Actual (reported)May 2021
Actual (reported)August 23, 2021
Actual (reported)Grip Strength
Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.
Pre-operative, 1, 3 and 5 years follow-up
Key Pinch Strength
Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
Pre-operative, 1, 3 and 5 years follow-up
Tip Pinch Strength
Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
Pre-operative, 1, 3 and 5 years follow-up
VAS Pain
Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain).
Pre-operative, 1, 3 and 5 years follow-up
Motion - ROM Measurement - Radial Abduction
Pre-operative, 1, 3 and 5 years follow-up
Motion - ROM Measurement - Palmar Abduction
Pre-operative, 1, 3 and 5 years follow-up
EQ-5D - Health Status Score
Pre-operative, 1, 3 and 5 years follow-up
EQ-5D - VAS Score
Pre-operative, 1, 3 and 5 years follow-up
Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis
1, 3 and 5 years follow-up
Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.
SPM Deurne
Deurne, 2100, Belgium
Frederik VERSTREKEN, PhD
SPM Deurne
100 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2013
First Posted
July 19, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2020
Actual (reported)Study Completion
May 2021
Actual (reported)Last Updated
October 18, 2021
Results First Posted
August 23, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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