Scapholunate Ligament Partial TearsNCT05102357
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability
An observational study of Scapholunate Ligament Partial Tears, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Scapholunate Ligament Partial Tears
- What is being tested?
- Conservative Treatment (splint)
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Sep 2021
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Scapholunate ligament Injury
- Wrist Extrinsic Ligament Injury
Who cannot join
- Scapholunate Dissociation
- Radiological and clinical instable wrist
- Carpal bone fracture
- MRI imaging artefact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scapholunate Ligament Partial Tears
- Being tested
- Conservative Treatment (splint)
- Keywords
- Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Treatment (splint)Procedure or surgery
splint 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jan 2019
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate Ligament Partial TearsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Karaalioglu, MD, Istanbul Medipol University Hospital
- Investigators
- Adnan Kara, Study director, Medipol University Hospital Department of OrthopedicsBanu Karaalioğlu, Principal investigator, Medipol University Hospital Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102357
- Sponsor's protocol ID
- Scapholunate Ligament Tear
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Trial, Scapholunate Ligament Partial Tears in Stable Wrist
- ClinicalTrials.gov ID
- NCT05102357
- Acronym / sponsor ID
- Scapholunate Ligament Tear
- Conditions
- Scapholunate Ligament Partial Tears
- Keywords
- Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Nov 2021 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Scapholunate ligament Injury
- Wrist Extrinsic Ligament Injury
Key exclusion criteria (4 listed)
- Scapholunate Dissociation
- Radiological and clinical instable wrist
- Carpal bone fracture
- MRI imaging artefact
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 |
|---|---|---|
| Conservative Treatment (splint)splint 6 weeks | Procedure or surgery | – |
Primary outcome
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.
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 8 Nov 2021.
- Individual participant dataSharing planned: No
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.
Adnan Kara study director
Medipol University Hospital Department of Orthopedics
Banu Karaalioğlu principal investigator
Medipol University Hospital Department of Radiology
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 Scapholunate Ligament Partial Tears, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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 8 Nov 2021. 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 Turkey (Türkiye). 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?
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). 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 8 Nov 2021.