Distal Interphalangeal ArthroplastyNCT03074916
Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint
An observational study of Distal Interphalangeal Arthroplasty and Distal Interphalangeal Arthrodesis, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis. The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up. Read more about this study
- Who is it for?
- Ages 18 to 111 years
- Conditions the study is for
- Distal Interphalangeal Arthroplasty, Distal Interphalangeal Arthrodesis
- What is being tested?
- DIP arthroplasty or arthrodesis
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 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 18 to 111 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP arthrodesis
Who may be able to join
- Arthroplasty group:
- DIP silicone arthroplasty at least one year ago
- Informed consent as documented by signature
- Arthrodesis group:
- Matched patients with an DIP arthrodesis
- Informed consent as documented by signature
Who cannot join
- Arthroplasty group:
- Silicone arthroplasty at the thumb IP joint
- Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
- Arthrodesis group:
Show all 10Show fewer
- Arthroplasty at another DIP joint
- Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.
The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.
- Being tested
- DIP arthroplasty or arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIP arthroplasty or arthrodesisDevice
Arthroplasty of the DIP Joint or arthrodesis of the DIP joint
| Study group | Role | What they receive |
|---|---|---|
| DIP arthroplasty | Not described Receives: Device: DIP arthroplasty or arthrodesis | |
| DIP arthrodesis | Not described Receives: Device: DIP arthroplasty or arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up
Question to be answered on a 5 Point Likert scale
Measured: at least 1 year up to 7 years
Secondary outcomes (1)
Michigan Hand Questionnaire
Questionnaire about Hand function scored 0-100
Measured: at least 1 year up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start8 Mar 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 Distal Interphalangeal ArthroplastyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074916
- Sponsor's protocol ID
- DIP_Silicone_retro
- Status last verified
- Apr 2018
- First submitted
- 23 Feb 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint
- ClinicalTrials.gov ID
- NCT03074916
- Acronym / sponsor ID
- DIP_Silicone_retro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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 objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.
The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIP arthroplasty | – | Device: DIP arthroplasty or arthrodesis |
| DIP arthrodesis | – | Device: DIP arthroplasty or arthrodesis |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP arthrodesis
Key inclusion criteria (6 listed)
- DIP silicone arthroplasty at least one year ago
- Informed consent as documented by signature
- Matched patients with an DIP arthrodesis
- Informed consent as documented by signature
Key exclusion criteria (10 listed)
- Silicone arthroplasty at the thumb IP joint
- Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
- Arthroplasty at another DIP joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIP arthroplasty or arthrodesisArthroplasty of the DIP Joint or arthrodesis of the DIP joint | Device | DIP arthrodesis, DIP arthroplasty |
Primary outcome
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up
Time frame: at least 1 year up to 7 years
Question to be answered on a 5 Point Likert scale
1 secondary outcome
Michigan Hand Questionnaire
Time frame: at least 1 year up to 7 years
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.
- Individual participant dataSharing planned: No
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 Distal Interphalangeal Arthroplasty and Distal Interphalangeal Arthrodesis, 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 6 inclusion and 10 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?
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up (time frame: at least 1 year up to 7 years). 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.