Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients

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.

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Instability
• Intervention / Treatment: Procedure: Latarjet; Procedure: Bankart

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Mika Paavola, MD PhD
  • Jyväskylä, Finland
    • Recruiting
    • Keski-Suomen Keskussairaala
    • Contact: Juha Paloneva, MD PhD
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Antti Joukainen, MD PhD
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Tapio Flinkkilä, Adjunct Professor
  • Pori, Finland
    • Recruiting
    • Satakunnan Keskussairaala
    • Contact: Juha Kukkonen, MD PhD
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Vesa Lepola, MD PhD
  • Tampere, Finland
    • Recruiting
    • Hatanpään sairaala
    • Contact: Janne Lehtinen, Adjunct Professor
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Sami Elamo, MD; Email: spelam@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence of instability	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.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
shoulder state	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.	5 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Ville Äärimaa, Adjunct Professor, Turku University Hospital

Publications and helpful links

General Publications

• Kukkonen J, Elamo S, Flinkkila T, Paloneva J, Mantysaari M, Joukainen A, Lehtinen J, Lepola V, Holstila M, Kauko T, Aarimaa V; FINNISH (Finnish Instability Shoulder Study) Investigators. Arthroscopic Bankart versus open Latarjet as a primary operative treatment for traumatic anteroinferior instability in young males: a randomised controlled trial with 2-year follow-up. Br J Sports Med. 2022 Mar;56(6):327-332. doi: 10.1136/bjsports-2021-104028. Epub 2021 Sep 22.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: November 24, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 24, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: surgical treatment; Latarjet; Bankart; redislocation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: FINNISH