Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumer... | NCT01805050

Studies
Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumeral Ligament)

NCT01805050

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Shoulder Injuries and Disorders

Interventions

Arthroscopically repair of the anterior shoulder instability

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 4, 2013

First Submission Date that Met QC Criteria

Mar 4, 2013

First Posted Date

Mar 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 22, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess KlinikPrincipal Investigator

Lead Sponsor

Schulthess KlinikOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New Technique		All patients who underwent surgical repair of the anterior instability due an HAGL lesion.	Procedure: Arthroscopically repair of the anterior shoulder instability

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arthroscopically repair of the anterior shoulder instability	Procedure	Arthroscopically repair of the anterior shoulder instability	New Technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOSI-Score		expected average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Sociodemographic Dates		expected average of 2 years
x-ray images		expected average of 2 years
Constant-Murley Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Flury, Dr	Upper Extremities Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schulthess Klinik		Zurich	Canton of Zürich		Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D000070599	Shoulder Injuries
D004194	Disease

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided