Comparison of ARPE Prosthesis With the Literature

September 21, 2021 updated by: Zimmer Biomet

Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 analysis will be used.

The 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 post-operative HR QOL
  • Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used,

Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Deurne, Belgium, 2100
        • SPM Deurne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.

Description

Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.

Inclusion Criteria:

  • patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
  • patients willing to return for follow up evaluation.

Exclusion Criteria:

  • local or systemic infections
  • severe muscular, neurological or vascular deficiencies of the extremity involved
  • bone destruction or poor bone to affect implant stability
  • allergy to any of the components of the implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
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
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
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
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
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
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motion - ROM Measurement - Radial Abduction
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm.
Pre-operative, 1, 3 and 5 years follow-up
Motion - ROM Measurement - Palmar Abduction
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm.
Pre-operative, 1, 3 and 5 years follow-up
EQ-5D - Health Status Score
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Pre-operative, 1, 3 and 5 years follow-up
EQ-5D - VAS Score
Time Frame: Pre-operative, 1, 3 and 5 years follow-up
The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Pre-operative, 1, 3 and 5 years follow-up
Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis
Time Frame: 1, 3 and 5 years follow-up
Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported.
1, 3 and 5 years follow-up
Hand Function: DASH Questionnaire - Disability
Time Frame: Pre-operative, 1, 3 and 5 years follow-up

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
Pre-operative, 1, 3 and 5 years follow-up
Hand Function: DASH Questionnaire - Work
Time Frame: Pre-operative, 1, 3 and 5 years follow-up

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
Pre-operative, 1, 3 and 5 years follow-up
Hand Function: DASH Questionnaire - Sport
Time Frame: Pre-operative, 1, 3 and 5 years follow-up

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
Pre-operative, 1, 3 and 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Biomet Belgium BVBA

Investigators

  • Principal Investigator: Frederik VERSTREKEN, PhD, SPM Deurne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (ESTIMATE)

July 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.E16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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