NCT01912027

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

1.2 years

First QC Date

July 18, 2013

Last Update Submit

October 9, 2013

Conditions

Shoulder Instability

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arthroscopic Latarjet technique

EXPERIMENTAL

Arthroscopic Latarjet technique

Procedure: Arthroscopic Latarjet techniques

Open Latarjet technique

ACTIVE COMPARATOR

Open Latarjet technique

Procedure: Open Latarjet technique

Interventions

Open Latarjet techniquePROCEDURE
Open Latarjet technique
Arthroscopic Latarjet techniquesPROCEDURE
Arthroscopic Latarjet technique

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

Beijing Jishuitan Hospital

Beijng, Beijing Municipality, 0086, China

ACTIVE NOT RECRUITING

Study Officials

  • Chunyan Jiang, MD

    Beijing Jishuitan Hospitial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

F Li, MD

CONTACT

0086-010-58516202long_bmu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 30, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

CN(2)