Joint InstabilityLatarjetNCT02505932
Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
An observational study of Joint Instability, run by Hospital Ambroise Paré Paris at 2 sites in France.
Trial summary
To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Instability
- What is being tested?
- Arthroscopic Latarjet procedure and Mini-open Latarjet procedure
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2012to Dec 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 with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Who may be able to join
- chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Who cannot join
- Patient refusal
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital Ambroise Paré Paris
Boulogne-Billancourt, 92000
Clinique des Maussins
Paris
About this study
To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.
Read the detailed description
This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).
- Conditions
- Joint Instability
- Being tested
- Arthroscopic Latarjet procedure, Mini-open Latarjet procedure
- Keywords
- Shoulder instability
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Latarjet procedureProcedure or surgery
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
Mini-open Latarjet procedureProcedure or surgery
mini-open approach (set Arthrex, Naples, FL)
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Latarjet procedure | arthroscopic approach (set Depuy-Mitek, Raynham, MA) Receives: Procedure: Arthroscopic Latarjet procedure | |
| Mini-open Latarjet procedure | mini-open approach (set Arthrex, Naples, FL) Receives: Procedure: Mini-open Latarjet procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Measured: Average during the first week
Secondary outcomes (6)
Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Measured: Daily from day1 to day7
analgesic consumption (Number of pills)
Measured: Daily from day1 to day7
presence of postoperative discomfort symptoms (yes/no)
The presence (yes/no) of incision site pain, nausea, vomiting, vertigo, anxiety
Measured: Daily from day1 to day7
coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan
Measured: Between 3 to 6 months follow-up
Recurrence rate of shoulder instability (number of recurrence/total number of patients)
Measured: 2-year minimal follow-up
Functional evaluation of patients
Western Ontario Score Index (WOSI)
Measured: 2-year minimal follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InstabilityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
- Investigators
- Shahnaz Klouche, MD, Study director, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505932
- Sponsor's protocol ID
- APR012012
- Acronym
- Latarjet
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
- ClinicalTrials.gov ID
- NCT02505932
- Acronym / sponsor ID
- Latarjet / APR012012
- Conditions
- Joint Instability
- Keywords
- Shoulder instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jul 2015 (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.
To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.
Detailed description
This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Latarjet procedure | – | Procedure: Arthroscopic Latarjet procedurearthroscopic approach (set Depuy-Mitek, Raynham, MA) |
| Mini-open Latarjet procedure | – | Procedure: Mini-open Latarjet proceduremini-open approach (set Arthrex, Naples, FL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Key inclusion criteria (1 listed)
- chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| Arthroscopic Latarjet procedurearthroscopic approach (set Depuy-Mitek, Raynham, MA) | Procedure or surgery | Arthroscopic Latarjet procedure |
| Mini-open Latarjet proceduremini-open approach (set Arthrex, Naples, FL) | Procedure or surgery | Mini-open Latarjet procedure |
Primary outcome
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Time frame: Average during the first week
6 secondary outcomes
Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Time frame: Daily from day1 to day7
analgesic consumption (Number of pills)
Time frame: Daily from day1 to day7
presence of postoperative discomfort symptoms (yes/no)
Time frame: Daily from day1 to day7
coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan
Time frame: Between 3 to 6 months follow-up
Recurrence rate of shoulder instability (number of recurrence/total number of patients)
Time frame: 2-year minimal follow-up
Functional evaluation of patients
Time frame: 2-year minimal follow-up
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 Jul 2015.
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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.
Shahnaz Klouche, MD study director
Hospital Ambroise Paré Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Instability, run by Hospital Ambroise Paré Paris 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 1 inclusion and 1 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 Jul 2015. 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 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?
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain) (time frame: Average during the first week). 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 Jul 2015.