Shoulder InstabilityNCT01912027
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
A study testing Open Latarjet technique and Arthroscopic Latarjet techniques in people with Shoulder Instability, run by Fenglong Li, MD at 2 sites in China.
Trial summary
The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Instability
- What is being tested?
- Open Latarjet technique and Arthroscopic Latarjet techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2013to May 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 15 years
- Traumatic anterior shoulder instability
- Recurrent instability
- Glenoid defects larger than 25%
- Clinical and radiographic data at pre-operation and follow-up
Who cannot join
- Younger than 18 years
- Non-traumatic shoulder instability
- Primary episode of instability
- Glenoid defects less than 25%
- Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
LI, long_bmu@163.com
- Active, not recruiting
Beijing Jishuitan Hospital
Beijng, Beijing Municipality, 0086
About this study
The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.
- Conditions
- Shoulder Instability
- Being tested
- Open Latarjet technique, Arthroscopic Latarjet techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Latarjet techniqueProcedure or surgery
Arthroscopic Latarjet techniquesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Latarjet technique | Experimental | Arthroscopic Latarjet technique Receives: Procedure: Arthroscopic Latarjet techniques |
| Open Latarjet technique | Active comparator | Open Latarjet technique Receives: Procedure: Open Latarjet technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film .
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenglong Li, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fenglong Li, MD, Beijing Jishuitan Hospital
- Investigators
- Chunyan Jiang, MD, Principal investigator, Beijing Jishuitan Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912027
- Sponsor's protocol ID
- JST1307A2
- Other IDs
- JST130701
- Status last verified
- Oct 2013
- First submitted
- 18 Jul 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT01912027
- Acronym / sponsor ID
- JST1307A2
- Conditions
- Shoulder Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fenglong Li, MDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 30 Jul 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.
The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Latarjet technique | Experimental | Procedure: Arthroscopic Latarjet techniquesArthroscopic Latarjet technique |
| Open Latarjet technique | Active comparator | Procedure: Open Latarjet techniqueOpen Latarjet technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age older than 15 years
- Traumatic anterior shoulder instability
- Recurrent instability
- Glenoid defects larger than 25%
- Clinical and radiographic data at pre-operation and follow-up
Key exclusion criteria (5 listed)
- Younger than 18 years
- Non-traumatic shoulder instability
- Primary episode of instability
- Glenoid defects less than 25%
- Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear
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 |
|---|---|---|
| Open Latarjet technique | Procedure or surgery | Open Latarjet technique |
| Arthroscopic Latarjet techniques | Procedure or surgery | Arthroscopic Latarjet technique |
Primary outcome
The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film .
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
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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.
Chunyan Jiang, MD principal investigator
Beijing Jishuitan Hospitial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Latarjet technique and Arthroscopic Latarjet techniques in people with Shoulder Instability, run by Fenglong Li, MD at 2 sites in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Oct 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact F Li, MD (0086-010-58516202, long_bmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film . (time frame: up to 3 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 11 Oct 2013.