Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)

Официальное название

SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations

Обзор

The goal of this prospective observational cohort study is to provide epidemiological and prognostic data from a defined urban population and to improve understanding of risk factors and long-term outcomes following first-time anterior shoulder dislocation in patients aged 16 years and older presenting to the Oslo Accident and Emergency Outpatient Clinic. The main questions the study aims to answer are: * What is the incidence of first-time anterior shoulder dislocations in the Oslo region? * What is the prevalence and extent of bipolar bone loss and soft tissue injuries measured by CT and MR after a first-time shoulder dislocation? * Does bone loss increase the risk of recurrent shoulder instability? * How do imaging findings and recurrence influence long-term shoulder function and quality of life? Participants will: * Undergo standard clinical evaluation and conventional radiographs as part of routine care and asked to participate and followed longitudinally * Be offered additional CT and MRI imaging to assess glenoid and humeral bone loss and to evaluate soft tissue injuries. * Complete electronic questionnaires (WOSI, EQ-5D-5L, pain score, Rowe score, return to sport/work) at 3 months, 1 year, 5 years, and 10 years. * Be invited to long-term follow-up, including radiographs at 10 years to evaluate signs of osteoarthritis.

Подробное описание

Traumatic anterior shoulder dislocation is a common injury, particularly among young and active individuals. Recurrence after a first-time anterior dislocation is frequent and varies substantially depending on age, activity level, and structural injury. Established risk factors include young age, male sex, hyperlaxity, participation in contact or overhead sports and concomitant bony or soft tissue injury. Despite the high recurrence risk in selected patient groups, most first-time dislocators are treated non-operatively in current Norwegian practice.

Subtle bony defects may be underdiagnosed on plain radiographs. Approximately one-third of patients sustain a bony Bankart lesion, and more than 70% present with a Hill-Sachs lesion. The size and location of the Hill-Sachs lesion, as well as its on-track/off-track classification, have implications for treatment strategy. CT with three-dimensional reconstruction is considered the most reliable method for assessing glenoid and humeral bone loss, while MRI enables detailed evaluation of associated soft tissue injuries, including labral and capsuloligamentous lesions.

The SALTO study is a prospective observational cohort including all eligible patients aged ≥16 years presenting with first-time anterior shoulder dislocation at a defined urban emergency clinic. The study will systematically assess bone loss using CT and characterize soft tissue injuries using MRI. Patients will be followed longitudinally with clinical data and patient-reported outcome measures to evaluate recurrence, shoulder function, and long-term shoulder function.

By correlating imaging findings with recurrent instability and long-term outcomes, the study aims to improve risk stratification after first-time anterior shoulder dislocation and identify patients who may benefit from early surgical intervention.

Первичные конечные точки

• Epidemiology of first time shoulder dislocations in Oslo, Norway [Срок оценки: From enrollment through completion of inclusion, an average of 2 years]
• Prevalence of bipolar bone loss assessed by CT [Срок оценки: Baseline]
• Prevalence of soft tissue injury assessed by MRI [Срок оценки: Baseline]

Вторичные конечные точки (8)

• Recurrence of instability after first time shoulder dislocation [Срок оценки: From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years]
• Patient reported outcomes and shoulder function (WOSI) [Срок оценки: 3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation]
• Glenohumeral osteoarthritis after first time shoulder dislocation [Срок оценки: 10 years after first time shoulder dislocation]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: 3 months, 1, 2, 5 years and 10 years]
• Shoulder pain intensity [Срок оценки: 3 months, 1 year, 2 years, 5 years and 10 years]
• Shoulder function (Rowe Score) [Срок оценки: 3 months and 10 years]
• Return to sport [Срок оценки: 3 months, 1 year, 2, 5 years and 10 years]
• EQ-VAS [Срок оценки: 3 months, 1,2,5 and 10 years]

Критерии участия

Критерии включения

• Age ≥16 years
• Diagnosis of first-time traumatic anterior shoulder dislocation
• Resident in the Oslo region who presents to Oslo Accident and Emergency Outpatient Clinic for treatment or follow-up within two weeks after initial injury
• Ability to provide informed consent

Критерии исключения

• Previous shoulder dislocation requiring reduction (Patients uncertain about prior dislocation are excluded)
• Age < 16 years
• Chronic substance abuse affecting compliance
• Inability to understand Norwegian or English
• Adult not able to provide consent or severe medical or psychiatric condition precluding follow-up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Публикации

• Wasserstein DN, Sheth U, Colbenson K, Henry PD, Chahal J, Dwyer T, Kuhn JE. The True Recurrence Rate and Factors Predicting Recurrent Instability After Nonsurgical Management of Traumatic Primary Anterior Shoulder Dislocation: A Systematic Review. Arthroscopy. 2016 Dec;32(12):2616-2625. doi: 10.1016/j.arthro.2016.05.039. Epub 2016 Jul 31. PMID 27487737
• Rutgers C, Verweij LPE, Priester-Vink S, van Deurzen DFP, Maas M, van den Bekerom MPJ. Recurrence in traumatic anterior shoulder dislocations increases the prevalence of Hill-Sachs and Bankart lesions: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):2130-2140. doi: 10.1007/s00167-021-06847-7. Epub 2022 Jan 6. PMID 34988633
• Olds M, Ellis R, Donaldson K, Parmar P, Kersten P. Risk factors which predispose first-time traumatic anterior shoulder dislocations to recurrent instability in adults: a systematic review and meta-analysis. Br J Sports Med. 2015 Jul;49(14):913-22. doi: 10.1136/bjsports-2014-094342. Epub 2015 Apr 21. PMID 25900943
• Nakagawa S, Iuchi R, Hanai H, Hirose T, Mae T. The Development Process of Bipolar Bone Defects From Primary to Recurrent Instability in Shoulders With Traumatic Anterior Instability. Am J Sports Med. 2019 Mar;47(3):695-703. doi: 10.1177/0363546518819471. Epub 2019 Jan 23. PMID 30673556
• Liavaag S, Svenningsen S, Reikeras O, Enger M, Fjalestad T, Pripp AH, Brox JI. The epidemiology of shoulder dislocations in Oslo. Scand J Med Sci Sports. 2011 Dec;21(6):e334-40. doi: 10.1111/j.1600-0838.2011.01300.x. Epub 2011 Apr 21. PMID 21507063
• Hurley ET, Manjunath AK, Bloom DA, Pauzenberger L, Mullett H, Alaia MJ, Strauss EJ. Arthroscopic Bankart Repair Versus Conservative Management for First-Time Traumatic Anterior Shoulder Instability: A Systematic Review and Meta-analysis. Arthroscopy. 2020 Sep;36(9):2526-2532. doi: 10.1016/j.arthro.2020.04.046. Epub 2020 May 8. PMID 32389771
• Enger M, Skjaker SA, Nordsletten L, Pripp AH, Melhuus K, Moosmayer S, Brox JI. Sports-related acute shoulder injuries in an urban population. BMJ Open Sport Exerc Med. 2019 Aug 12;5(1):e000551. doi: 10.1136/bmjsem-2019-000551. eCollection 2019. PMID 31548901
• Dickens JF, Slaven SE, Cameron KL, Pickett AM, Posner M, Campbell SE, Owens BD. Prospective Evaluation of Glenoid Bone Loss After First-time and Recurrent Anterior Glenohumeral Instability Events. Am J Sports Med. 2019 Apr;47(5):1082-1089. doi: 10.1177/0363546519831286. PMID 30943084

Идентификаторы

NCT: NCT07486440 · 24/07976

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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