Distal Radioulnar JointNCT03556527
Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch
An observational study of Distal Radioulnar Joint, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Distal Radioulnar Joint
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Apr 2018to 26 Apr 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vertebral impingement due to wrist ulnar pain, patients who have undergone ulnar shortening surgery.
Who may be able to join
- The distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. Therefore, the ulnar shortening surgery is accepted.
Who cannot join
- Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Jung-Pan Wang, M.D.,Ph.D.
About this study
Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. Some theories have pointed out this Instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. Therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or Reshaping of joints and clinically corresponding changes in results.
- Conditions
- Distal Radioulnar Joint
- Keywords
- osteotomy, reverse oblique sigmoid notch, ulnar impaction syndrome, ulnar shortening
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Item Pain intensity Measure
Each item is scored 0-10(0=no pain;10=pain as bad as can be)
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start26 Apr 2018
- Primary completion26 Apr 2019 (estimated)
- Study completion26 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radioulnar JointStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556527
- Sponsor's protocol ID
- 2018-05-005CC
- Status last verified
- Apr 2018
- First submitted
- 4 Jun 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch
- ClinicalTrials.gov ID
- NCT03556527
- Acronym / sponsor ID
- 2018-05-005CC
- Conditions
- Distal Radioulnar Joint
- Keywords
- osteotomy, reverse oblique sigmoid notch, ulnar impaction syndrome, ulnar shortening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 26 Apr 2019 (estimated)
- Study completion
- 26 Apr 2019 (estimated)
- First posted
- 14 Jun 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.
Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. Some theories have pointed out this Instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. Therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or Reshaping of joints and clinically corresponding changes in results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vertebral impingement due to wrist ulnar pain, patients who have undergone ulnar shortening surgery.
Key inclusion criteria (1 listed)
- The distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. Therefore, the ulnar shortening surgery is accepted.
Key exclusion criteria (1 listed)
- Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.
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
4-Item Pain intensity Measure
Time frame: 5 seconds
Each item is scored 0-10(0=no pain;10=pain as bad as can be)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
Related trials for Distal Radioulnar Joint
Recruiting
Norwegian Distal Ulna Resection - Replacement Study
Osteoarthritis Wrist
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.
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 Radioulnar Joint, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Jung-Pan, M.D.,Ph.D (02-28757557 ext. 1125, jpwang801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-Item Pain intensity Measure (time frame: 5 seconds). 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 14 Jun 2018.