Anterior Shoulder DislocationSALTONCT07486440
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
An observational study of Anterior Shoulder Dislocation and Shoulder Dislocation Closed Traumatic, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic, First Time Shoulder Dislocation
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 15 Apr 2026to Apr 2037
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Oslo University Hospital
Oslo
Martine Enger, +47 93035414, uxrten@ous-hf.no
About this study
Official title: SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations
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:
Read more
- 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.
Read the 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.
- Conditions
- Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic, First Time Shoulder Dislocation, Shoulder Instability, Hill Sach Lesion, Bankart Lesion
- Keywords
- First time shoulder dislocation, Shoulder instability, Primary shoulder dislocation, Recurrence, Bone loss, traumatic anterior shoulder dislocation, prospective
- Medical subject headings
- Bankart Lesions, Recurrence, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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).
Measured: Baseline
Secondary outcomes (8)
Recurrence of instability after first time shoulder dislocation
Prevalence of recurrent instability after first time shoulder dislocation, defined as glenohumeral redislocation requiring reduction. To identify clinical, demographic, and imaging-related risk factors, especially bipolar bone loss, for recurrent instability.
Measured: From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years
Patient reported outcomes and shoulder function (WOSI)
Patient-reported shoulder function measured using the Western Ontario Shoulder Instability Index (WOSI) score. The WOSI score ranges from 0 to 2100, where lower scores indicate better shoulder function and quality of life. Scores may be converted to a percentage scale ranging from 0-100%, where higher scores indicate better shoulder function and quality of life.
Measured: 3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation
Glenohumeral osteoarthritis after first time shoulder dislocation
To evaluate radiographic signs of glenohumeral osteoarthritis at 10-year follow-up and examine their association with recurrence and baseline bone loss
Measured: 10 years after first time shoulder dislocation
Health-related quality of life (EQ-5D-5L)
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Responses from the five dimensions will be converted into an EQ-5D-5L index score using the Norwegian value set. The index score ranges from less than 0 (health states worse than death) to 1 (perfect health), where higher scores indicate better health-related quality of life.
Measured: 3 months, 1, 2, 5 years and 10 years
Shoulder pain intensity
Shoulder pain intensity measured using the Visual Analogue Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.
Measured: 3 months, 1 year, 2 years, 5 years and 10 years
Shoulder function (Rowe Score)
To measure general shoulder function included pain, stability, range and function using the Rowe Score, ranging from 0 to 100, where higher scores indicate better shoulder stability and function.
Measured: 3 months and 10 years
Return to sport
Return to sport after first-time shoulder dislocation assessed using a patient questionnaire evaluating whether the participant has returned to sport and at what level compared with pre-injury activity.
Measured: 3 months, 1 year, 2, 5 years and 10 years
EQ-VAS
EQ-VAS is a self-reported health status measured using the EQ-5D visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: 3 months, 1,2,5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completionApr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anterior Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tea Berge, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486440
- Sponsor's protocol ID
- 24/07976
- Acronym
- SALTO
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data are stored in a secure research database (TSD, University of Oslo) containing sensitive health information. De-identified data may be considered for sharing with other researchers upon reasonable request and subject to approval by the data protection authorities and the study investigators.
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.
PubMed 27487737Rutgers 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.
PubMed 34988633Olds 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.
PubMed 25900943Nakagawa 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.
PubMed 30673556Liavaag 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.
PubMed 21507063Hurley 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.
PubMed 32389771Enger 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.
PubMed 31548901Dickens 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.
PubMed 30943084Di 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 Jan;30(1):90-8. doi: 10.1016/j.arthro.2013.10.004.
PubMed 24384275Delage Royle A, Balg F, Bouliane MJ, Canet-Silvestri F, Garant-Saine L, Sheps DM, Lapner P, Rouleau DM. 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 Oct 30;5(10):2325967117733660. doi: 10.1177/2325967117733660. eCollection 2017 Oct.
PubMed 29119123Belk JW, Wharton BR, Houck DA, Bravman JT, Kraeutler MJ, Mayer B, Noonan TJ, Seidl AJ, Frank RM, McCarty EC. 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 May;51(6):1634-1643. doi: 10.1177/03635465211065403. Epub 2022 Feb 11.
PubMed 35148222
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations
- ClinicalTrials.gov ID
- NCT07486440
- Acronym / sponsor ID
- SALTO / 24/07976
- Conditions
- Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic, First Time Shoulder Dislocation, Shoulder Instability, Hill Sach Lesion, Bankart Lesion
- Keywords
- First time shoulder dislocation, Shoulder instability, Primary shoulder dislocation, Recurrence, Bone loss, traumatic anterior shoulder dislocation, prospective
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of first time shoulder dislocations in Oslo, Norway
Time frame: From enrollment through completion of inclusion, an average of 2 years
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
Prevalence of bipolar bone loss assessed by CT
Time frame: Baseline
Presence and extent of bipolar bone loss (glenoid bone loss and Hill-Sachs lesion) assessed using computed tomography (CT)
Prevalence of soft tissue injury assessed by MRI
Time frame: Baseline
Presence of soft tissue injuries (e.g., Bankart lesion, ALPSA lesion, HAGL lesion, SLAP lesion, rotator cuff injury) assessed using magnetic resonance imaging (MRI).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 27487737Wasserstein 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.
- Background: PubMed 34988633Rutgers 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.
- Background: PubMed 25900943Olds 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.
- Background: PubMed 30673556Nakagawa 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.
- Background: PubMed 21507063Liavaag 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.
- Background: PubMed 32389771Hurley 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.
- Background: PubMed 31548901Enger 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.
- Background: PubMed 30943084Dickens 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.
- Background: PubMed 24384275Di 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 Jan;30(1):90-8. doi: 10.1016/j.arthro.2013.10.004.
- Background: PubMed 29119123Delage Royle A, Balg F, Bouliane MJ, Canet-Silvestri F, Garant-Saine L, Sheps DM, Lapner P, Rouleau DM. 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 Oct 30;5(10):2325967117733660. doi: 10.1177/2325967117733660. eCollection 2017 Oct.
- Background: PubMed 35148222Belk JW, Wharton BR, Houck DA, Bravman JT, Kraeutler MJ, Mayer B, Noonan TJ, Seidl AJ, Frank RM, McCarty EC. 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 May;51(6):1634-1643. doi: 10.1177/03635465211065403. Epub 2022 Feb 11.
- Individual participant dataSharing planned: Undecided. Individual participant data are stored in a secure research database (TSD, University of Oslo) containing sensitive health information. De-identified data may be considered for sharing with other researchers upon reasonable request and subject to approval by the data protection authorities and the study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Shoulder Dislocation and Shoulder Dislocation Closed Traumatic, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tea Berge (+47 95751146, teaberge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of first time shoulder dislocations in Oslo, Norway (time frame: From enrollment through completion of inclusion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07486440, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.