Comparison of ARPE Prosthesis With the Literature

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904019
• Other study ID #: ORTHO.CR.E16
• Status: Completed
• Start date: April 2013
• Est. completion date: May 2021

Study information

• Verified date: September 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Locations

Country	Name	City	State
Belgium	SPM Deurne	Deurne

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Biomet Belgium BVBA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Motion - ROM Measurement - Radial Abduction	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
Secondary	Motion - ROM Measurement - Palmar Abduction	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
Secondary	EQ-5D - Health Status Score	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
Secondary	EQ-5D - VAS Score	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
Secondary	Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis	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
Secondary	Hand Function: DASH Questionnaire - Disability	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
Secondary	Hand Function: DASH Questionnaire - Work	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
Secondary	Hand Function: DASH Questionnaire - Sport	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