Finger JointNCT01740999
Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint
A study testing silicone arthroplasty and arthrodesis in people with Finger Joint and Arthroplasty, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Finger Joint, Arthroplasty, Replacement
- What is being tested?
- silicone arthroplasty and arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary osteoarthritis in the distal interphalangeal joint
- require surgical treatment
- patient aged 18 years and over
- signed written informed consent
Who cannot join
- posttraumatic osteoarthritis
- rheumatoid disease
- pregnant woman
- any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- legal incompetence
- no knowledge of German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.
The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.
- Conditions
- Finger Joint, Arthroplasty, Replacement
- Being tested
- silicone arthroplasty, arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone arthroplastyProcedure or surgery
silicone arthroplasty
arthrodesisProcedure or surgery
arthrodesis
| Study group | Role | What they receive |
|---|---|---|
| silicone arthroplasty | Experimental | silicone arthroplasty Receives: Procedure: silicone arthroplasty |
| arthrodesis | Active comparator | arthrodesis Receives: Procedure: arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Questionnaire (MHQ)
Comparison of silicone arthroplasty and arthrodesis in respect to MHQ
Measured: 12 months postoperative
Secondary outcomes (1)
Change of Michigan Hand Questionnaire Score
Measured: preoperative, 3mo/6mo/36mo postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Kluge, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740999
- Sponsor's protocol ID
- DIP_01
- Status last verified
- Apr 2016
- First submitted
- 27 Nov 2012
- Last updated
- 18 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
- ClinicalTrials.gov ID
- NCT01740999
- Acronym / sponsor ID
- DIP_01
- Conditions
- Finger Joint, Arthroplasty, Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2012 (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 operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.
The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone arthroplasty | Experimental | Procedure: silicone arthroplastysilicone arthroplasty |
| arthrodesis | Active comparator | Procedure: arthrodesisarthrodesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary osteoarthritis in the distal interphalangeal joint
- require surgical treatment
- patient aged 18 years and over
- signed written informed consent
Key exclusion criteria (6 listed)
- posttraumatic osteoarthritis
- rheumatoid disease
- pregnant woman
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone arthroplastysilicone arthroplasty | Procedure or surgery | silicone arthroplasty |
| arthrodesisarthrodesis | Procedure or surgery | arthrodesis |
Primary outcome
Michigan Hand Questionnaire (MHQ)
Time frame: 12 months postoperative
Comparison of silicone arthroplasty and arthrodesis in respect to MHQ
1 secondary outcome
Change of Michigan Hand Questionnaire Score
Time frame: preoperative, 3mo/6mo/36mo postoperative
Results and safety
The study was stopped early (reason given: Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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?
A study testing silicone arthroplasty and arthrodesis in people with 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: stopped early, as of the sponsor's last update on 18 Apr 2016. 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 was stopped early (reason given: Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.). Results are not available in the source record.
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?
Michigan Hand Questionnaire (MHQ) (time frame: 12 months postoperative). 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 Apr 2016.