Comparison of ARPE Prosthesis With the Literature
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|ClinicalTrials.gov Identifier: NCT01904019|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : July 7, 2020
|Condition or disease|
The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis1 will be used.
Secondary objectives are:
- to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
- to determine pre- and postop HR QOL
- Incidence of RLL at each follow up time point. Literature values from the same meta analysis1 will be used.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Trapezia-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
- Functional outcome [ Time Frame: 3 years follow-up ]Functional outcome: hand function, strength (grip, key pinch & tip pinch)
- pain evaluation [ Time Frame: 5 years follow-up ]Pain level collected on a horizontal line, rated from 0 (no pain) to 100 (very severe pain)
- hand function [ Time Frame: 5 years follow-up ]- functional outcomes at 1 and 5 years follow up after trapezio-metacarpal arthroplasty / trapeziectomy and trapeziectomy with LRTI.
- Motion [ Time Frame: 5 years follow-up ]- ROM (palmar and radial abduction)at 1, 3 & 5 years follow-up
- Quality of life determined by the EQ-5D score [ Time Frame: 5 years follow-up ]
EQ-5D is a standardized instrument for measuring health status. It is made up for two components.
The description part: health status is measured in five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself. Usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have. In anxiety/depression dimension, it asks how anxious or depressed they are.
Visual analogue scale: The patient marks his health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. The bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
- Radiographic assessment [ Time Frame: 5 years follow-up ]- Incidence of Radiolucency lines at 1, 3 & 5 years follow-up
- adverse event [ Time Frame: as requested ]- frequency of postoperative adverse events
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): NCT01904019
|Deurne, Belgium, 2100|
|Principal Investigator:||Frederik VERSTREKEN, PhD||SPM Deurne|