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Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients

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ClinicalTrials.gov Identifier: NCT01998048
Recruitment Status : Unknown
Verified May 2015 by Ville Aarimaa, Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Ville Aarimaa, Turku University Hospital

Brief Summary:
Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of shoulder instability aims at restoration of shoulder stability. The purpose of this trial is to investigate the difference in outcome after arthroscopic Bankart operation compared with open Latarjet operation in the treatment of a residual instability after a traumatic primary dislocation in young males.

Condition or disease Intervention/treatment Phase
Shoulder Instability Procedure: Latarjet Procedure: Bankart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients. The Outcome of Arthroscopic Bankart vs. Open Latarjet Stabilization Surgery, a Randomized Controlled Trial.
Study Start Date : November 2013
Estimated Primary Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Latarjet
60 patients treated with open Latarjet operation
Procedure: Latarjet
A diagnostic arthroscopy is performed before the Latarjet operation in general anaesthesia. In case of a significant Hill-Sachs defect an additional remplissage procedure may be performed according to surgeons' decision by inserting 1 to 2 more suture anchors according to surgeon's preference into the deepest portion of the Hill-Sachs defect and tying the infraspinatus tendon down to fill the bony defect. Thereafter an open Latarjet operation is performed using standard techniques described by Walch or de Beer. A deltopectoral incision is used. The coracoid process is osteotomized and ventrally prepared to bleeding bone. The coracoid process is then transferred through the middle of the subscapularis and re-attached on to the freshened neck of the glenoid, just medial to the joint line with two screws and washers, according to the surgeon's preference.

Active Comparator: Bankart
60 patients treated with arthroscopic Bankart operation
Procedure: Bankart
An arthroscopic Bankart operation is performed in general anaesthesia according to current practise (Provencher 2010). The intra-articular findings are recorded and the anteroinferior labrum and the IGHL are mobilized until subscapular muscle fibers can be seen. The IGHL complex is then re-attached to the freshened neck of the glenoid with 2 to 3 suture anchors according to surgeon's preference to re-create labral bumper and capsular tension. In case of a significant Hill-Sachs defect an additional remplissage procedure may be performed according to surgeon's decision by inserting 1 to 2 more suture anchors, according to surgeon's preference into the deepest portion of the Hill-Sachs defect and tying the infraspinatus tendon down to fill the bony defect.




Primary Outcome Measures :
  1. recurrence of instability [ Time Frame: 5 years ]
    The recurrence of instability (re-dislocation, subluxation, positive apprehension) is used as a primary outcome measure together with WOSI score two and five years postoperatively.


Other Outcome Measures:
  1. shoulder state [ Time Frame: 5 years ]
    Secondary outcome measures include: level and intensity to perform sports activities, subjective visual analogue estimation of the shoulder condition, Constant score, Oxford score, and SSV.



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subluxation or fear of shoulder dislocation after a previous, reduced and primarily conservatively treated (for more than 3 months) traumatic anteroinferior shoulder dislocation, or redislocation after a primary shoulder dislocation.
  2. Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
  3. X-ray (true ap, 30 degrees oblique ap, Y- and axillary projections), 2- and 3-dimensional computed tomography (2D and 3D CT) and magnetic resonance imaging arthrography (MRA) documentation of the joint.
  4. Congruency of the shoulder joint on imaging investigations.
  5. Young adult male patient 16-25 years of age (15 years < patient < 26 years ).
  6. Patient's willingness for operative treatment.
  7. Written informed consent from participating subject.

Exclusion Criteria:

  1. Non-congruency of the glenohumeral joint on imaging investigations.
  2. Concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than Hill-Sachs lesion or bony Bankart lesion)
  3. Severe grade 2 or above (Samilson et Prieto) osteoarthrosis of the glenohumeral joint detected in X-ray investigation.
  4. A humeral avulsion of glenohumeral ligaments (HAGL) detected in MRA investigation.
  5. Concomitant ipsilateral plexus or axillar nerve injury affecting motor function.
  6. Life threatening other concomitant injuries (i.e. multitrauma patient).
  7. Stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side).
  8. Age under 16 or above 25 years.
  9. Open physis with significant growth expectation.
  10. Intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998048


Contacts
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Contact: Sami Elamo, MD +35823130000 spelam@utu.fi
Contact: Ville Äärimaa, Adjunct professor +35823130000 vilaari@utu.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Mika Paavola, MD PhD         
Keski-Suomen keskussairaala Recruiting
Jyväskylä, Finland
Contact: Juha Paloneva, MD PhD         
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Antti Joukainen, MD PhD         
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Tapio Flinkkilä, Adjunct Professor         
Satakunnan keskussairaala Recruiting
Pori, Finland
Contact: Juha Kukkonen, MD PhD         
Hatanpään sairaala Recruiting
Tampere, Finland
Contact: Janne Lehtinen, Adjunct Professor         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Vesa Lepola, MD PhD         
Turku University Hospital Recruiting
Turku, Finland
Contact: Sami Elamo, MD       spelam@utu.fi   
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Ville Äärimaa, Adjunct Professor Turku University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ville Aarimaa, adjunct professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01998048    
Other Study ID Numbers: FINNISH
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Ville Aarimaa, Turku University Hospital:
surgical treatment
Bankart
Latarjet
redislocation
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases