NCT01998048

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.

Trial Health

55
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

8 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

November 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

4.1 years

First QC Date

November 24, 2013

Last Update Submit

May 24, 2015

Conditions

Shoulder Instability

Keywords

surgical treatmentBankartLatarjetredislocation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • shoulder state

    5 years

Study Arms (2)

Latarjet

ACTIVE COMPARATOR

60 patients treated with open Latarjet operation

Procedure: Latarjet

Bankart

ACTIVE COMPARATOR

60 patients treated with arthroscopic Bankart operation

Procedure: Bankart

Interventions

LatarjetPROCEDURE

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.

Latarjet
BankartPROCEDURE

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.

Bankart

Eligibility Criteria

Age16 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
  • 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.
  • Congruency of the shoulder joint on imaging investigations.
  • Young adult male patient 16-25 years of age (15 years \< patient \< 26 years ).
  • Patient's willingness for operative treatment.
  • Written informed consent from participating subject.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Keski-Suomen keskussairaala

Jyväskylä, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Satakunnan keskussairaala

Pori, Finland

RECRUITING

Hatanpään sairaala

Tampere, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34551902DERIVED

Study Officials

  • Ville Äärimaa, Adjunct Professor

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sami Elamo, MD

CONTACT

+35823130000spelam@utu.fi

Ville Äärimaa, Adjunct professor

CONTACT

+35823130000vilaari@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
adjunct professor

Study Record Dates

First Submitted

November 24, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2017

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

FI(8)