- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05102357
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability
October 31, 2021 updated by: Banu Karaalioglu, MD, Istanbul Medipol University Hospital
Retrospective Trial, Scapholunate Ligament Partial Tears in Stable Wrist
The purpose of this study is to investigate scapholunate ligament partial tears regarding tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to scrutinize conservative treatment response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients admitted with radial sided wrist pain without carpal instability were retrospectively evaluated.
Scapholunate interosseous ligament (SLIOL) tear localization, grade of injury and associated extrinsic ligament injuries were examined on MRI.
Patients treated conservatively and recalled at their first year for re-evaluation.
Study Type
Observational
Enrollment (Actual)
104
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
-
-
Istanbul
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Başakşehi̇r, Istanbul, Turkey
- Banu Karaalioğlu
-
-
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
12 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
109 of 311 patients admitted with radial sided wrist pain had SLL and/or extrinsic ligament injury on MRI, 49,5% (n:55) were female, 50,5% (n:56) male with mean age 34 ± 10 (age range, 12-67 years).
Description
Inclusion Criteria:
- Scapholunate ligament Injury
- Wrist Extrinsic Ligament Injury
Exclusion Criteria:
- Scapholunate Dissociation
- Radiological and clinical instable wrist
- Carpal bone fracture
- MRI imaging artefact
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: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in visual analog scale for pain, disabilities of the arm, shoulder and hand questionnaire and Patient-Rated Wrist Evaluation scores from baseline and at first year
Time Frame: Baseline and 1 year
|
Visual analog scale for pain scored from 0 to 10, disabilities of the arm, shoulder and hand questionnaire scored and Patient-Rated Wrist Evaluation scores from from 0 to 100 were scaled at initial admission, before treatment and at their first year recruitment after treatment for assessment conservative treatment success.
|
Baseline and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Adnan Kara, Medipol University Hospital Department of Orthopedics
- Principal Investigator: Banu Karaalioğlu, Medipol University Hospital Department of Radiology
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)
January 1, 2019
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
October 20, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2021
Last Update Submitted That Met QC Criteria
October 31, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Scapholunate Ligament Tear
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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