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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latarjet | Active Comparator | 60 patients treated with open Latarjet operation |
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| Bankart | Active Comparator | 60 patients treated with arthroscopic Bankart operation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latarjet | Procedure | 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sami Elamo, MD | Contact | +35823130000 | spelam@utu.fi | |
| Ville Äärimaa, Adjunct professor | Contact | +35823130000 | vilaari@utu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Ville Äärimaa, Adjunct Professor | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551902 | Derived | 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. |
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| Bankart | Procedure | 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. |
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| Keski-Suomen keskussairaala | Recruiting | Jyväskylä | Finland |
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| Kuopio University Hospital | Recruiting | Kuopio | Finland |
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| Oulu University Hospital | Recruiting | Oulu | Finland |
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| Satakunnan keskussairaala | Recruiting | Pori | Finland |
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| Hatanpään sairaala | Recruiting | Tampere | Finland |
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| Tampere University Hospital | Recruiting | Tampere | Finland |
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| Turku University Hospital | Recruiting | Turku | Finland |
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