- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03556527
Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch
June 4, 2018 updated by: Taipei Veterans General Hospital, Taiwan
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- Taipei Veterans General Hospital
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Contact:
- Jung-Pan Wang, M.D.,Ph.D.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Vertebral impingement due to wrist ulnar pain, patients who have undergone ulnar shortening surgery.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2018
Primary Completion (Anticipated)
April 26, 2019
Study Completion (Anticipated)
April 26, 2019
Study Registration Dates
First Submitted
June 4, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 14, 2018
Study Record Updates
Last Update Posted (Actual)
June 14, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-05-005CC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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