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

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
      • 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

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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