Anterior Shoulder DislocationNCT03424421
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
A study testing subscapular sling in people with Anterior Shoulder Dislocation and Joint Instability, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
The arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be tested clinically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Shoulder Dislocation, Joint Instability
- What is being tested?
- subscapular sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 20 Dec 2017to 30 Aug 2032
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical anterior instability of the shoulder and/or previous failed Bankart repair or arthroscopic findings concluding with too weak anterior structures to perform capsulolabral or labrum repair
- Be able to understand oral and written Norwegian /English
Who cannot join
- Cuff injury or previous cuff repair
- Surgical fracture treatment of the glenoid or humeral head
- Other instability procedures in the shoulder except Bankart repair and anterior capsular plications
- Previous infections in the shoulder
- MRI detectable fatty infiltration of the subscapularis or partial/total tendon rupture
- Severe glenohumeral arthrosis
- Multidirectional or posterior instability
- Not able to comply fully with the protocol due to psychosocial and physical conditions
Trial locations and contacts
1 site in 1 country.
Norway1 site
Aalesund Hospital Møre and Romsdal Hospital Trust
Ålesund, Ålesund, 6013
About this study
Official title: Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure
The arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be tested clinically. The procedure stabilizes the shoulder by using a semitendinosus graft that makes a new labrum and a sling around the subscapular tendon. Extensive biomechanical robotic testing of the procedure shows significant less translation and thus better stability of the humeral head with the sling compared to a normal Bankart repair. The investigators consider the biomechanical results after robotic testing sufficient to advocate a planned pilot study in humans. In this pilot study the clinical and radiological results of the sling will be investigated in a small number of cases. The safety of the subscapular sling procedure will be assessed. This studies results are expected to be a further step towards implementation of the sling procedure as a surgical option for shoulder instability.
- Conditions
- Anterior Shoulder Dislocation, Joint Instability
- Being tested
- subscapular sling
- Keywords
- Shoulder Joint, Orthopedics, Arthroscopy
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subscapular slingProcedure or surgery
semitendinosus subscapular sling procedure
| Study group | Role | What they receive |
|---|---|---|
| subscapular sling | Experimental | semitendinosus subscapular sling procedure Receives: Procedure: subscapular sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of shoulder dislocation after the subscapular sling
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations
Measured: 2 , 5 and 10 years follow up.
Secondary outcomes (2)
Changes in the Western Ontario Shoulder Instability index (WOSI) score
Changes in the WOSI score, comparing results preoperatively
Measured: 2, 5 and 10 years follow up.
Changes in the range of motions
Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder
Measured: 2, 5 and 10 years follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start20 Dec 2017
- Primary completion5 Feb 2024
- Study completion30 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Shoulder DislocationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jon Olav Drogset, MD PhD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424421
- Sponsor's protocol ID
- 2017/1292
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klungsoyr PJ, Guldal F, Vagstad T, Klungsoyr JA. A new subscapular sling operation to stabilize the shoulder. A cadaver study. J Exp Orthop. 2015 Dec;2(1):12. doi: 10.1186/s40634-015-0028-y. Epub 2015 Jun 2.
PubMed 26914880
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure
- ClinicalTrials.gov ID
- NCT03424421
- Acronym / sponsor ID
- 2017/1292
- Conditions
- Anterior Shoulder Dislocation, Joint Instability
- Keywords
- Shoulder Joint, Orthopedics, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Norwegian University of Science and Technology, Oslo University Hospital
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 30 Aug 2032 (estimated)
- First posted
- 7 Feb 2018 (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 arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be tested clinically. The procedure stabilizes the shoulder by using a semitendinosus graft that makes a new labrum and a sling around the subscapular tendon. Extensive biomechanical robotic testing of the procedure shows significant less translation and thus better stability of the humeral head with the sling compared to a normal Bankart repair. The investigators consider the biomechanical results after robotic testing sufficient to advocate a planned pilot study in humans. In this pilot study the clinical and radiological results of the sling will be investigated in a small number of cases. The safety of the subscapular sling procedure will be assessed. This studies results are expected to be a further step towards implementation of the sling procedure as a surgical option for shoulder instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| subscapular sling | Experimental | Procedure: subscapular slingsemitendinosus subscapular sling procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical anterior instability of the shoulder and/or previous failed Bankart repair or arthroscopic findings concluding with too weak anterior structures to perform capsulolabral or labrum repair
- Be able to understand oral and written Norwegian /English
Key exclusion criteria (8 listed)
- Cuff injury or previous cuff repair
- Surgical fracture treatment of the glenoid or humeral head
- Other instability procedures in the shoulder except Bankart repair and anterior capsular plications
- Previous infections in the shoulder
- MRI detectable fatty infiltration of the subscapularis or partial/total tendon rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subscapular slingsemitendinosus subscapular sling procedure | Procedure or surgery | subscapular sling |
Primary outcome
The recurrence rate of shoulder dislocation after the subscapular sling
Time frame: 2 , 5 and 10 years follow up.
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations
2 secondary outcomes
Changes in the Western Ontario Shoulder Instability index (WOSI) score
Time frame: 2, 5 and 10 years follow up.
Changes in the range of motions
Time frame: 2, 5 and 10 years follow up.
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 11 Aug 2026.
- Background: PubMed 26914880Klungsoyr PJ, Guldal F, Vagstad T, Klungsoyr JA. A new subscapular sling operation to stabilize the shoulder. A cadaver study. J Exp Orthop. 2015 Dec;2(1):12. doi: 10.1186/s40634-015-0028-y. Epub 2015 Jun 2.
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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. This study is not recruiting at the moment.
Jon Olav Drogset, MD PhD prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subscapular sling in people with Anterior Shoulder Dislocation and Joint Instability, run by Helse Møre og Romsdal HF 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate of shoulder dislocation after the subscapular sling (time frame: 2 , 5 and 10 years follow up.). 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 NCT03424421, which also lists 1 linked publication.
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 11 Aug 2026.