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Trial record 2 of 4 for:    624747 [PUBMED-IDS]

Does Shoulder Stabilizations Stabilize Shoulders?

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ClinicalTrials.gov Identifier: NCT02725333
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Adrien Schwitzguebel, La Tour Hospital

Brief Summary:

Background: There is no evidence that shoulder stabilization effectively corrects the glenohumeral translation in unstable shoulders, explaining residual apprehension in certain patients. The purpose of this study was to analyze the effect of surgical stabilization on glenohumeral translation.

Methods: Anteroposterior and superoinferior translations were assessed in patients, before and after shoulder stabilization, through a dedicated patient-specific measurement technique based on optical motion capture and computed tomography.


Condition or disease Intervention/treatment Phase
Shoulder Dislocation Shoulder Pain Joint Instability Syndrome Procedure: Shoulder Stabilization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Shoulder Stabilizations Stabilize Shoulders?
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Shoulder Stabilization
Anteroposterior and superoinferior translations were assessed in patients, before and after shoulder stabilization, through a dedicated patient-specific measurement technique based on optical motion capture and computed tomography.
Procedure: Shoulder Stabilization
Open Latarjet was performed as the standard and well-described Latarjet-Patte procedure with subscapularis split and triple locking mechanism.14 The graft was intra-articular in every case, the capsule was systematically reattached to glenoid according to Favard's modification,15 and a capsular shift was added. Arthroscopic Latarjet was carried out in one case according to a modified Lafosse technique.16 In the latter treatment option, no reattachment of the capsule was realized. The arthroscopic Bankart repair consisted in a mobilization of the anteroinferior capsule and the labrum with an arthroscopic elevator. The glenoid rim and neck were then prepared with a mechanical shaver device. Two loaded anchors were inserted at the 5 and 3 o'clock position, and sutures were shuttled across the inferior glenohumeral ligament and labrum, starting at the inferior position and progressing in a superior direction.
Other Names:
  • Open Latarjet
  • Arthroscopic Latarjet
  • Bankart




Primary Outcome Measures :
  1. Comparison of ipsilateral glenohumeral translation (unstable side) pre- and postoperatively. [ Time Frame: 1 year ]
    Percentage of glenohumeral translation.

  2. Comparison of glenohumeral translation between ipsilateral side (unstable side) and contralateral (stable) side. [ Time Frame: 1 year ]
    Percentage of glenohumeral translation


Secondary Outcome Measures :
  1. Prevalence of postoperative apprehension, new dislocation or subluxation in relation to the main outcomes of interest. [ Time Frame: 1 year ]
  2. Range of motion [ Time Frame: 1 year ]
    Comparison of glenohumeral range of motion pre-postoperatively


Other Outcome Measures:
  1. Age, sex, shoulder side, and limb dominance [ Time Frame: 1 year ]
    Baseline characteristics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anteroinferior shoulder stabilization

Exclusion Criteria:

  • Incomplete documentation
  • Follow-up of less than twelve months
  • History of bilateral instability
  • Previous shoulder surgery
  • Contraindications for computed tomography
  • Non-traumatic onset
  • Hyperlaxity. The latter was defined as more than 85° of external rotation at the elbow against the waist{Coudane, 2000 #3124} or hyperabduction by more than 105°.{Gagey, 2001 #1915}

Publications:

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Responsible Party: Adrien Schwitzguebel, MD, La Tour Hospital
ClinicalTrials.gov Identifier: NCT02725333     History of Changes
Other Study ID Numbers: AMG 12-18
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adrien Schwitzguebel, La Tour Hospital:
Glenohumeral stabilization
Computer tomography
Subtle or minor instability
Unstable painful shoulder
Apprehension
Dislocation
Subluxation
Kinematics modeling
Biomechanics
Motion capture
3D simulation
Additional relevant MeSH terms:
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Shoulder Pain
Joint Dislocations
Shoulder Dislocation
Joint Instability
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Shoulder Injuries