AzTrials
AzTrials

Shoulder DislocationIACE ScanNCT02426996

The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation

A study testing Scan of shoulder in people with Shoulder Dislocation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Shoulder Dislocation
What is being tested?
Scan of shoulder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesFrance
Study dates
May 2016to 4 May 2017
Phase
Interventional
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 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient was operated for chronic anterior shoulder instability (defined by a history of at least two true dislocations and an ISIS score> 2) 6 weeks ago (+/- 5 days)

Who cannot join

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Clinique Saint Jean

    Montpellier, 34093

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Treatment of Chronic Anterior Shoulder Instability by a Latarjet-type Bone Block Procedure Using the SEM (Science Et Medecine) Positioning Tool: Using a Scan to Assess Consolidation and Return to Normal Activity at 3 Months

The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.

Read the detailed description

The secondary objectives of this study are to assess:

  1. the position of the block according to a shoulder scan at 3 months post-surgery
  2. functional scores (Constant, Walch-Duplay) at 6 weeks, 3 and 6 months post surgery.
  3. Complications: osteoarthritis, lysis of the block.
  4. pain.
  5. date of return to full activity.
  6. patient satisfaction concerning care (visual analog scale at 6 months post-surgery).
Being tested
Scan of shoulder
Medical subject headings
Shoulder Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scan of shoulderProcedure or surgery

    A scan (no injection) of the concerned shoulder will be performed at 3 months post-surgery. Cuts in three planes of space, including all of the glenoid. 3D reconstructions.

Study groups in NCT02426996
Study groupRoleWhat they receive
Study populationExperimentalThe patients included have been operated for chronic anterior shoulder instability by a Latarjet-type bone block procedure using the SEM (Science Et Medecine) positioning tool within the past 3 months. Intervention: Scan of shoulder
Receives: Procedure: Scan of shoulder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Did the patient return to activity at 3 months? yes/no

    Measured: Week 6 after inclusion, which = 3 months after surgery

Secondary outcomes (16)

  1. Constant score

    Measured: week -6

  2. Constant score

    Measured: day 0 (study inclusion)

  3. Constant score

    Measured: week 6

  4. Constant score

    Measured: week 18

  5. Walch-Duplay score

    Measured: week -6

  6. Walch-Duplay score

    Measured: day 0 (study inclusion)

  7. Walch-Duplay score

    Measured: week 6

  8. Walch-Duplay score

    Measured: week 18

  9. Presence/absence of complications

    Measured: day 0 (study inclusion)

  10. Presence/absence of complications

    Measured: week 6

  11. Presence/absence of complications

    Measured: week 18

  12. Visual analog scale for pain

    Measured: day 0 (study inclusion)

  13. Visual analog scale for pain

    Measured: week 6

  14. Visual analog scale for pain

    Measured: week 18

  15. Date of return to total activity

    Measured: week 18

  16. Visual analog scale for satisfaction

    Measured: week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2015 (estimated)
  2. Study startMay 2016
  3. Primary completion4 May 2017
  4. Study completion4 May 2017

Why it stopped: Recruiting patients difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02426996
Sponsor's protocol ID
LOCAL/2014/OM-01
Other IDs
2015-A00155-44
Acronym
IACE Scan
Status last verified
Aug 2017
First submitted
15 Apr 2015
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Scan of shoulder in people with Shoulder Dislocation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

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 6 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: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 was stopped early (reason given: Recruiting patients difficulties). Results are not available in the source record.

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?

Did the patient return to activity at 3 months? yes/no (time frame: Week 6 after inclusion, which = 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02426996.

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 3 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in