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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01912027
Other study ID # JST1307A2
Secondary ID JST130701
Status Recruiting
Phase N/A
First received July 18, 2013
Last updated October 9, 2013
Start date January 2013
Est. completion date May 2014

Study information

Verified date October 2013
Source Beijing Jishuitan Hospital
Contact F Li, MD
Phone 0086-010-58516202
Email long_bmu@163.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical 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. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Open Latarjet technique

Arthroscopic Latarjet techniques


Locations

Country Name City State
China Beijing Jishuitan Hospital Beijing Beijing
China Beijing Jishuitan Hospital Beijng Beijing

Sponsors (1)

Lead Sponsor Collaborator
Fenglong Li, MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . up to 3 years Yes
See also
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