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

NCT07486440 | Not Yet Recruiting

• 1 other identifier: 24/07976
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Shoulder Dislocation; First Time Shoulder Dislocation; Shoulder Instability; Hill Sach Lesion; Bankart Lesion; Shoulder Dislocation Closed Traumatic

Keywords

First time shoulder dislocation; Shoulder instability; Primary shoulder dislocation; Recurrence; Bone loss; traumatic anterior shoulder dislocation; prospective

Outcome Measures

Primary Outcomes (3)

• Epidemiology of first time shoulder dislocations in Oslo, Norway

  Incidence of first-time anterior shoulder dislocations in the Oslo region and prevalence of bipolar bone loss and soft tissue injuries assessed by CT and MRI

  From enrollment through completion of inclusion, an average of 2 years

• Prevalence of bipolar bone loss assessed by CT

  Presence and extent of bipolar bone loss (glenoid bone loss and Hill-Sachs lesion) assessed using computed tomography (CT)

  Baseline

• Prevalence of soft tissue injury assessed by MRI

  Presence of soft tissue injuries (e.g., Bankart lesion, ALPSA lesion, HAGL lesion, SLAP lesion, rotator cuff injury) assessed using magnetic resonance imaging (MRI).

  Baseline

Secondary Outcomes (8)

• Recurrence of instability after first time shoulder dislocation

  From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years

• Patient reported outcomes and shoulder function (WOSI)

  3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation

• Glenohumeral osteoarthritis after first time shoulder dislocation

  10 years after first time shoulder dislocation

• Health-related quality of life (EQ-5D-5L)

  3 months, 1, 2, 5 years and 10 years

• Shoulder pain intensity

  3 months, 1 year, 2 years, 5 years and 10 years

Study Arms (1)

Traumatic first time anterior shoulder dislocators

All eligible patients presenting with first-time anterior shoulder dislocation at Oslo Accident and Emergency Outpatient Clinic (Oslo University Hospital, OUS) during the inclusion period will be asked to participate and followed longitudinally.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients presenting with first-time anterior shoulder dislocation at Oslo Accident and Emergency Outpatient Clinic (Oslo University Hospital, OUS) during the inclusion period will be asked to participate.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (11)

• Wasserstein DN, Sheth U, Colbenson K, et al. The True Recurrence Rate and Factors Predicting Recurrent Instability After Nonsurgical Management of Traumatic Primary Anterior Shoulder Dislocation: A Systematic Review. Arthroscopy. 2016;32(12):2616-2625.

  BACKGROUND

• Rutgers C, Verweij LPE, Priester-Vink S, et al. 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;30(6):2130-2140.

  BACKGROUND

• 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;49(14):913-922.

  BACKGROUND

• 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;47(3):695-703.

  BACKGROUND

• Liavaag S, Svenningsen S, Reikerås O, et al. The epidemiology of shoulder dislocations in Oslo. Scand J Med Sci Sports. 2011;21(6):e334-340.

  BACKGROUND

• Hurley ET, Manjunath AK, Bloom DA, et al. Arthroscopic Bankart Repair Versus Conservative Management for First-Time Traumatic Anterior Shoulder Instability: A Systematic Review and Meta-analysis. Arthroscopy. 2020;36(9):2526-2532.

  BACKGROUND

• Enger M, Skjaker SA, Nordsletten L, et al. Sports-related acute shoulder injuries in an urban population. BMJ Open Sport Exerc Med. 2019;5(1):e000551.

  BACKGROUND

• Dickens JF, Slaven SE, Cameron KL, et al. Prospective Evaluation of Glenoid Bone Loss After First-time and Recurrent Anterior Glenohumeral Instability Events. Am J Sports Med. 2019;47(5):1082-1089.

  BACKGROUND

• Di Giacomo G, Itoi E, Burkhart SS. Evolving concept of bipolar bone loss and the Hill-Sachs lesion: from "engaging/non-engaging" lesion to "on-track/off-track" lesion. Arthroscopy. 2014;30(1):90-98.

  BACKGROUND

• Delage Royle A, Balg F, Bouliane MJ, et al. Indication for Computed Tomography Scan in Shoulder Instability: Sensitivity and Specificity of Standard Radiographs to Predict Bone Defects After Traumatic Anterior Glenohumeral Instability. Orthop J Sports Med. 2017;5(10):2325967117733660.

  BACKGROUND

• Belk JW, Wharton BR, Houck DA, et al. Shoulder Stabilization Versus Immobilization for First-Time Anterior Shoulder Dislocation: A Systematic Review and Meta-analysis of Level 1 Randomized Controlled Trials. Am J Sports Med. 2023;51(6):1634-1643.

  BACKGROUND

MeSH Terms

Conditions

Bankart Lesions; Recurrence; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Tea Berge

CONTACT

+47 95751146; teaberge@gmail.com

Martine Enger

CONTACT

+ 47 93035414; uxrten@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopaedic surgeon

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): April 1, 2037
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

NO (1)