Scheker Total Distal Radioulnar Joint ProsthesisNCT02676999
Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis
An observational study of Scheker Total Distal Radioulnar Joint Prosthesis, run by University of Zurich at 1 site in Switzerland.
Trial summary
This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scheker Total Distal Radioulnar Joint Prosthesis
- What is being tested?
- Implantation of a Scheker total distal radioulnar joint prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Jun 2020
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation, who were willing and able to give written informed consent to participate in the study.
Who may be able to join
- Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation
- 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.
Switzerland1 site
University Hospital Zurich, Center for Reconstructive Surgery
Zurich, Canton of Zurich, 8091
About this study
This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.
- Being tested
- Implantation of a Scheker total distal radioulnar joint prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a Scheker total distal radioulnar joint prosthesisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position.
Measured: Follow-up time between 12-60 months after primary implantation of the Scheker prothesis
Secondary outcomes (1)
Secondary outcomes of this study are radiological parameters, pain level by Visual Analog Scale, objective functional parameters (passive stability, grip strength), subjective functional parameters, and complications affecting the examined wrist.
Measured: Follow- up time between 12-60 months after primary implantation of the Scheker prothesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheker Total Distal Radioulnar Joint ProsthesisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676999
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0369
- Status last verified
- Feb 2016
- First submitted
- 14 Jan 2015
- Last updated
- 10 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis
- ClinicalTrials.gov ID
- NCT02676999
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0369
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 9 Feb 2016 (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.
This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation, who were willing and able to give written informed consent to participate in the study.
Key inclusion criteria (2 listed)
- Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of a Scheker total distal radioulnar joint prosthesis | Procedure or surgery | – |
Primary outcome
Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position.
Time frame: Follow-up time between 12-60 months after primary implantation of the Scheker prothesis
1 secondary outcome
Secondary outcomes of this study are radiological parameters, pain level by Visual Analog Scale, objective functional parameters (passive stability, grip strength), subjective functional parameters, and complications affecting the examined wrist.
Time frame: Follow- up time between 12-60 months after primary implantation of the Scheker prothesis
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 10 Nov 2020.
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 Scheker Total Distal Radioulnar Joint Prosthesis, run by University of Zurich 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 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 10 Nov 2020. 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?
Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position. (time frame: Follow-up time between 12-60 months after primary implantation of the Scheker prothesis). 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 10 Nov 2020.