Rheumatoid Arthritis - Hand JointNCT03626116
Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty
An observational study of Rheumatoid Arthritis - Hand Joint, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis - Hand Joint
- What is being tested?
- silicone metacarpophalangeal arthroplasty (SMPA)
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jul 2018to 19 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA
Who may be able to join
- Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- Informed Consent as documented by signature
Who cannot join
- Major surgery at another joint at the hand (e.g. 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
Official title: What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty
The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.
Read the detailed description
This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.
Participants fulfilling all of the following inclusion criteria are eligible for the project:
- Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- Informed Consent as documented by signature
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
- Conditions
- Rheumatoid Arthritis - Hand Joint
- Being tested
- silicone metacarpophalangeal arthroplasty (SMPA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone metacarpophalangeal arthroplasty (SMPA)Procedure or surgery
Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the treatment result assessed on a 5-point Likert Scale
The primary outcome is the satisfaction with the treatment result at least one year after surgery and its determinants.
It will be quantified using this question: How satisfied are you with the overall result of the SMPA surgery? The response options are: Very satisfied (score 1), somewhat satisfied (score 2), neither satisfied nor unsatisfied (score 3), somewhat unsatisfied (score 4), very unsatisfied (score 5).
For further analyses, this question can be dichotomized into the categories of "satisfied patients" (very satisfied / satisfied) and "unsatisfied patients" (neither satisfied nor dissatisfied or worse).
Measured: at least one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start18 Jul 2018
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis - Hand 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Schindele, MD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626116
- Sponsor's protocol ID
- MCP Arthroplasty RA patients
- Status last verified
- Apr 2019
- First submitted
- 19 Jul 2018
- Last updated
- 5 Apr 2019
- 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty
- ClinicalTrials.gov ID
- NCT03626116
- Acronym / sponsor ID
- MCP Arthroplasty RA patients
- Conditions
- Rheumatoid Arthritis - Hand Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 10 Aug 2018 (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 primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.
Detailed description
This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.
Participants fulfilling all of the following inclusion criteria are eligible for the project:
- Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- Informed Consent as documented by signature
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA
Key inclusion criteria (2 listed)
- Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- Informed Consent as documented by signature
Key exclusion criteria (3 listed)
- Major surgery at another joint at the hand (e.g. PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
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 metacarpophalangeal arthroplasty (SMPA)Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty | Procedure or surgery | – |
Primary outcome
Satisfaction with the treatment result assessed on a 5-point Likert Scale
Time frame: at least one year after surgery
The primary outcome is the satisfaction with the treatment result at least one year after surgery and its determinants. It will be quantified using this question: How satisfied are you with the overall result of the SMPA surgery? The response options are: Very satisfied (score 1), somewhat satisfied (score 2), neither satisfied nor unsatisfied (score 3), somewhat unsatisfied (score 4), very unsatisfied (score 5). For further analyses, this question can be dichotomized into the categories of "satisfied patients" (very satisfied / satisfied) and "unsatisfied patients" (neither satisfied nor dissatisfied or worse).
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 5 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis - Hand Joint
Active, not recruitingObservational study
Neuropathic Hand Pain in Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruiting
Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA
Active, not recruiting
Is a Standard Hand Rehabilitation Program Sufficient in Rheumatoid Arthritis Patients With Central Sensitization
Hand Exercises for Rheumatoid Arthritis
Not yet recruiting
Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis
Arthritis, Arthritis/Arthrosis
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.
Stephan Schindele, MD principal investigator
Schulthess Klinik
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 Rheumatoid Arthritis - Hand Joint, 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 2 inclusion and 3 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 5 Apr 2019. 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 assessed on a 5-point Likert Scale (time frame: at least one year after surgery). 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 5 Apr 2019.