NCT01805050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

March 4, 2013

Last Update Submit

March 20, 2017

Conditions

Shoulder Injuries and Disorders

Keywords

HAGLShoulder instability

Outcome Measures

Primary Outcomes (1)

  • WOSI-Score

    expected average of 2 years

Secondary Outcomes (8)

  • Sociodemographic Dates

    expected average of 2 years

  • x-ray images

    expected average of 2 years

  • Constant-Murley Score

    expected average of 2 years

  • Rowe - Score

    expected average of 2 years

  • SSV (Simple Shoulder Value)

    expected average of 2 years

  • +3 more secondary outcomes

Study Arms (1)

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

Arthroscopically repair of the anterior shoulder instabilityPROCEDURE

Arthroscopically repair of the anterior shoulder instability

New Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zürich, Switzerland

Location

MeSH Terms

Conditions

Shoulder InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Flury, Dr

    Upper Extremities Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Department of Upper Extremity)

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

CH(1)