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Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients

Primary Purpose

Shoulder Instability

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Latarjet
Bankart
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Instability focused on measuring surgical treatment, Bankart, Latarjet, redislocation

Eligibility Criteria

16 Years - 25 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Helsinki University HospitalRecruiting
  • Keski-Suomen keskussairaalaRecruiting
  • Kuopio University HospitalRecruiting
  • Oulu University HospitalRecruiting
  • Satakunnan keskussairaalaRecruiting
  • Hatanpään sairaalaRecruiting
  • Tampere University HospitalRecruiting
  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Latarjet

Bankart

Arm Description

60 patients treated with open Latarjet operation

60 patients treated with arthroscopic Bankart operation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2013
Last Updated
May 24, 2015
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01998048
Brief Title
Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Instability
Keywords
surgical treatment, Bankart, Latarjet, redislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Latarjet
Arm Type
Active Comparator
Arm Description
60 patients treated with open Latarjet operation
Arm Title
Bankart
Arm Type
Active Comparator
Arm Description
60 patients treated with arthroscopic Bankart operation
Intervention Type
Procedure
Intervention Name(s)
Latarjet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bankart
Intervention Description
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 Measure Information:
Title
recurrence of instability
Description
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.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
shoulder state
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sami Elamo, MD
Phone
+35823130000
Email
spelam@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Ville Äärimaa, Adjunct professor
Phone
+35823130000
Email
vilaari@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Äärimaa, Adjunct Professor
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mika Paavola, MD PhD
Facility Name
Keski-Suomen keskussairaala
City
Jyväskylä
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD PhD
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti Joukainen, MD PhD
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tapio Flinkkilä, Adjunct Professor
Facility Name
Satakunnan keskussairaala
City
Pori
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD PhD
Facility Name
Hatanpään sairaala
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janne Lehtinen, Adjunct Professor
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesa Lepola, MD PhD
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Elamo, MD
Email
spelam@utu.fi

12. IPD Sharing Statement

Citations:
PubMed Identifier
34551902
Citation
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.
Results Reference
derived

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Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients

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