Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic, First Time Shoulder Dislocation, Shoulder Instability. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations
Overview
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.
Detailed description
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.
Primary outcome measures
- Epidemiology of first time shoulder dislocations in Oslo, Norway [Time frame: From enrollment through completion of inclusion, an average of 2 years]
- Prevalence of bipolar bone loss assessed by CT [Time frame: Baseline]
- Prevalence of soft tissue injury assessed by MRI [Time frame: Baseline]
Secondary outcome measures (8)
- Recurrence of instability after first time shoulder dislocation [Time frame: From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years]
- Patient reported outcomes and shoulder function (WOSI) [Time frame: 3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation]
- Glenohumeral osteoarthritis after first time shoulder dislocation [Time frame: 10 years after first time shoulder dislocation]
- Health-related quality of life (EQ-5D-5L) [Time frame: 3 months, 1, 2, 5 years and 10 years]
- Shoulder pain intensity [Time frame: 3 months, 1 year, 2 years, 5 years and 10 years]
- Shoulder function (Rowe Score) [Time frame: 3 months and 10 years]
- Return to sport [Time frame: 3 months, 1 year, 2, 5 years and 10 years]
- EQ-VAS [Time frame: 3 months, 1,2,5 and 10 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Publications
- 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
Identifiers
NCT: NCT07486440 · 24/07976