Shoulder Injuries and DisordersNCT01805050
Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumeral Ligament)
An observational study of Shoulder Injuries and Disorders, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries and Disorders
- What is being tested?
- Arthroscopically repair of the anterior shoulder instability
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent surgical repair of the anterior instability due an HAGL lesion at the Schulthess Klinik and have been performed surgery by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey
Who may be able to join
- arthroscopically repair of the anterior instability of the shoulder due an HAGL lesion (performed by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey at the Schulthess Klinik)
- patients ≥18 years
- written informed consent
Who cannot join
- additional surgeries at the affected side after the index surgery (arthroscopically repair of the anterior instability due an HAGL lesion)
- non-compliance
- disorders which handicap or inhibit the patient to follow the orders of the clinical testers
- request of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopically Repair of the Anterior Instability of the Shoulder Due an HAGL - Lesion - A Case Serie
This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion.
Read the detailed description
The aim of the study is to describe and document the results of a case serie after an arthroscopically intervention to correct the anterior instability in the shoulder joint with one primary parameter (WOSI-Score) and several secondary parameters, which are used in the daily clinical routine (e.g.clinical examination, several questionnaires). The results of these parameters will be used to document the mid-term results (> 1 year after surgery).
- Conditions
- Shoulder Injuries and Disorders
- Being tested
- Arthroscopically repair of the anterior shoulder instability
- Keywords
- HAGL, Shoulder instability
- Medical subject headings
- Shoulder Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopically repair of the anterior shoulder instabilityProcedure or surgery
Arthroscopically repair of the anterior shoulder instability
| Study group | Role | What they receive |
|---|---|---|
| New Technique | All patients who underwent surgical repair of the anterior instability due an HAGL lesion. Receives: Procedure: Arthroscopically repair of the anterior shoulder instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOSI-Score
Measured: expected average of 2 years
Secondary outcomes (8)
Sociodemographic Dates
Measured: expected average of 2 years
x-ray images
Measured: expected average of 2 years
Constant-Murley Score
Measured: expected average of 2 years
Rowe - Score
Measured: expected average of 2 years
SSV (Simple Shoulder Value)
Measured: expected average of 2 years
SST (Simple Shoulder Test)
Measured: expected average of 2 years
Measurement of the abduction strength
Measured: expected average of 2 years
Measurement of the external rotation strength
Measured: expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Injuries and DisordersStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Flury, Schulthess Klinik
- Investigators
- Matthias Flury, Dr, Principal investigator, Upper Extremities Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805050
- Sponsor's protocol ID
- HAGL
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopically Repair of the Anterior Instability of the Shoulder Due an HAGL - Lesion - A Case Serie
- ClinicalTrials.gov ID
- NCT01805050
- Acronym / sponsor ID
- HAGL
- Conditions
- Shoulder Injuries and Disorders
- Keywords
- HAGL, Shoulder instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Mar 2013 (estimated)
- 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.
This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion.
Detailed description
The aim of the study is to describe and document the results of a case serie after an arthroscopically intervention to correct the anterior instability in the shoulder joint with one primary parameter (WOSI-Score) and several secondary parameters, which are used in the daily clinical routine (e.g.clinical examination, several questionnaires). The results of these parameters will be used to document the mid-term results (> 1 year after surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Technique | – | Procedure: Arthroscopically repair of the anterior shoulder instabilityAll patients who underwent surgical repair of the anterior instability due an HAGL lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent surgical repair of the anterior instability due an HAGL lesion at the Schulthess Klinik and have been performed surgery by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey
Key inclusion criteria (3 listed)
- arthroscopically repair of the anterior instability of the shoulder due an HAGL lesion (performed by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey at the Schulthess Klinik)
- patients ≥18 years
- written informed consent
Key exclusion criteria (4 listed)
- additional surgeries at the affected side after the index surgery (arthroscopically repair of the anterior instability due an HAGL lesion)
- non-compliance
- disorders which handicap or inhibit the patient to follow the orders of the clinical testers
- request of the patient
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 |
|---|---|---|
| Arthroscopically repair of the anterior shoulder instabilityArthroscopically repair of the anterior shoulder instability | Procedure or surgery | New Technique |
Primary outcome
WOSI-Score
Time frame: expected average of 2 years
8 secondary outcomes
Sociodemographic Dates
Time frame: expected average of 2 years
x-ray images
Time frame: expected average of 2 years
Constant-Murley Score
Time frame: expected average of 2 years
Rowe - Score
Time frame: expected average of 2 years
SSV (Simple Shoulder Value)
Time frame: expected average of 2 years
SST (Simple Shoulder Test)
Time frame: expected average of 2 years
Measurement of the abduction strength
Time frame: expected average of 2 years
Measurement of the external rotation strength
Time frame: expected average of 2 years
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 22 Mar 2017.
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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.
Matthias Flury, Dr principal investigator
Upper Extremities Department
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 Shoulder Injuries and Disorders, run by Schulthess Klinik at 1 site in Switzerland.
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 3 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 22 Mar 2017. 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 Switzerland. 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?
WOSI-Score (time frame: expected average of 2 years). 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 22 Mar 2017.