ArthritisNCT01904019
Comparison of ARPE Prosthesis With the Literature
An observational study of Arthritis, run by Zimmer Biomet at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.
Who may be able to join
- patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
- patients willing to return for follow up evaluation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis
- Keywords
- arthroplasty, trapezio-metacarpial
- Medical subject headings
- Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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).
Measured: Pre-operative, 1, 3 and 5 years follow-up
Secondary outcomes (8)
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
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).
Measured: Pre-operative, 1, 3 and 5 years follow-up
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.
Measured: 1, 3 and 5 years follow-up
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
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.
Measured: Pre-operative, 1, 3 and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet Belgium BVBA
- Responsible party
- Sponsor
- Investigators
- Frederik VERSTREKEN, PhD, Principal investigator, SPM Deurne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904019
- Sponsor's protocol ID
- ORTHO.CR.E16
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2013
- Last updated
- 18 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
- ClinicalTrials.gov ID
- NCT01904019
- Acronym / sponsor ID
- ORTHO.CR.E16
- Conditions
- Arthritis
- Keywords
- arthroplasty, trapezio-metacarpial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet Belgium BVBA
- Study start
- Apr 2013
- Primary completion
- Oct 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.
Key inclusion criteria (2 listed)
- patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
- patients willing to return for follow up evaluation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
8 secondary outcomes
Motion - ROM Measurement - Radial Abduction
Time frame: 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
EQ-5D - Health Status Score
Time frame: Pre-operative, 1, 3 and 5 years follow-up
EQ-5D - VAS Score
Time frame: 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
Hand Function: DASH Questionnaire - Disability
Time frame: 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
Hand Function: DASH Questionnaire - Sport
Time frame: Pre-operative, 1, 3 and 5 years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik VERSTREKEN, PhD principal investigator
SPM Deurne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Zimmer Biomet at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Pre-operative, 1, 3 and 5 years follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.