Finger JointNCT02425319
CapFlex-PIP© Motion
An observational study of Finger Joint and Arthroplasty, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Finger Joint, Arthroplasty, Replacement
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2017to 18 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or patient with one untreated healthy hand without joint osteoarthritis
Who may be able to join
- Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
- Patient with one untreated healthy hand without joint osteoarthritis
- Patient aged 50 years and over
- Patient willing and able to give written informed consent to participate in the study
Who cannot join
- Inflammatory disease (e.g. rheumatoid arthritis)
- Pregnant women
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Legal incompetence
- Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motion Analysis of the Proximal Interphalangeal Joint in Healthy Hands, as Well as in Osteoarthritis Hands Following Implantation With the New CapFlex-PIP© Implant Compared With Silicone Implants
The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.
- Conditions
- Finger Joint, Arthroplasty, Replacement, Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with CapFlex-PIP© implant | Not described | |
| patients with silicone implant | Not described | |
| patients with healthy PIP joints | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active PIP joint range of motion (flexion and extension lag) during motion analysis
Measured: 1-5 years postoperative
Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
Measured: 1-5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start14 Nov 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger JointStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Schindele, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425319
- Sponsor's protocol ID
- CapMotion
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Analysis of the Proximal Interphalangeal Joint in Healthy Hands, as Well as in Osteoarthritis Hands Following Implantation With the New CapFlex-PIP© Implant Compared With Silicone Implants
- ClinicalTrials.gov ID
- NCT02425319
- Acronym / sponsor ID
- CapMotion
- Conditions
- Finger Joint, Arthroplasty, Replacement, Motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with CapFlex-PIP© implant | – | – |
| patients with silicone implant | – | – |
| patients with healthy PIP joints | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or patient with one untreated healthy hand without joint osteoarthritis
Key inclusion criteria (4 listed)
- Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
- Patient with one untreated healthy hand without joint osteoarthritis
- Patient aged 50 years and over
- Patient willing and able to give written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Inflammatory disease (e.g. rheumatoid arthritis)
- Pregnant women
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Legal incompetence
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
Active PIP joint range of motion (flexion and extension lag) during motion analysis
Time frame: 1-5 years postoperative
Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
Time frame: 1-5 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Finger Joint and Arthroplasty, run by Schulthess Klinik at 1 site in Switzerland.
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 4 inclusion and 6 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 26 Apr 2018. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Active PIP joint range of motion (flexion and extension lag) during motion analysis (time frame: 1-5 years postoperative). The study lists 2 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 26 Apr 2018.