Comparison of ARPE Prosthesis With the Literature

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01904019

Enrollment

100

Registered

2013-07-19

Start date

2013-04-30

Completion date

2021-05-31

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

arthroplasty, trapezio-metacarpial

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Grip Strength	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.
Key Pinch Strength	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.
Tip Pinch Strength	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.
VAS Pain	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).

Secondary

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

Countries

Belgium

Participant flow

Pre-assignment details

According to the protocol, 100 subjects were to be enrolled. Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study.

Participants by arm

Arm	Count
ARPE Prosthesis Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.	95
ARPE Prosthesis Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.	100
Total	195

Withdrawals & dropouts

Period	Reason	FG000
1 Year Follow-up	Impossibility to contact patient	5
1 Year Follow-up	Withdrawal by Subject	4
3 Year Follow-up	Impossibility to contact patient	14
3 Year Follow-up	Withdrawal by Subject	1
5 Year Follow-up	Impossibility to contact patient	4
5 Year Follow-up	Withdrawal by Subject	2

Baseline characteristics

Characteristic	ARPE Prosthesis
Age, Continuous	62.3 years STANDARD_DEVIATION 7.2
Height Distribution	165.3 cm STANDARD_DEVIATION 7.4
Other Joint Involvement of the Hand No	31 implants
Other Joint Involvement of the Hand Yes	69 implants
Previous Hand Surgeries/Treatments on Affected Hand No	77 implants
Previous Hand Surgeries/Treatments on Affected Hand Yes	23 implants
Sex: Female, Male Female	87 implants
Sex: Female, Male Male	13 implants
Surgery Side Distribution Left	59 implants
Surgery Side Distribution Right	41 implants
Trapezio Metacarpal Arthritis Disease Stage Stage II	26 implants
Trapezio Metacarpal Arthritis Disease Stage Stage III	68 implants
Trapezio Metacarpal Arthritis Disease Stage Stage IV	6 implants
Weight Distribution	70.4 kg STANDARD_DEVIATION 14.5

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 95
other Total, other adverse events	19 / 95
serious Total, serious adverse events	17 / 95

Outcome results

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.