- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912027
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
October 9, 2013 updated by: Fenglong Li, MD
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: F Li, MD
- Phone Number: 0086-010-58516202
- Email: long_bmu@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100035
- Recruiting
- Beijing Jishuitan Hospital
-
Contact:
- LI
- Email: long_bmu@163.com
-
Beijng, Beijing, China, 0086
- Active, not recruiting
- Beijing Jishuitan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arthroscopic Latarjet technique
|
|
Active Comparator: Open Latarjet technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chunyan Jiang, MD, Beijing Jishuitan Hospitial
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
March 1, 2014
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
July 18, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
October 11, 2013
Last Update Submitted That Met QC Criteria
October 9, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- JST1307A2
- JST130701 (Other Identifier: Beijing Jishuitan Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Instability
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Ottawa Hospital Research InstituteActive, not recruiting
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Izmir Democracy UniversityNot yet recruitingSurgery | Anterior Shoulder Instability
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Society of Military Orthopedic SurgeonsCompleted
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Clinical Trials on Arthroscopic Latarjet techniques
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-
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-
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-
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-
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-
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