Shoulder InstabilityNCT06920654
Stabilization of the Shoulder Joint Using a Latarjet-like Procedure.
An observational study of Shoulder Instability, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
This retrospective cohort study aims to evaluate the clinical outcomes of patients who underwent arthroscopic shoulder stabilization using a bone block technique for chronic recurrent shoulder dislocations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Instability
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2025to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients who underwent arthroscopic shoulder stabilization with a bone block technique at a single orthopedic center. Approximately 40-50 patients are expected to be included, with a retrospective follow-up period of 1-10 years postoperatively.
Who may be able to join
- Patients who underwent surgery for chronic recurrent shoulder dislocations.
- Surgery performed between 1-10 years before study inclusion.
- Patients aged 18 years or older who provide informed consent.
Who cannot join
- Patients with other concurrent shoulder surgeries unrelated to bone block stabilization.
- Patients with major orthopedic conditions affecting the study outcome.
- Patients with insufficient follow-up data.
- Patients who do not provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This retrospective cohort study aims to evaluate the clinical outcomes of patients who underwent arthroscopic shoulder stabilization using a bone block technique for chronic recurrent shoulder dislocations. The study will assess complications, reoperations, and functional outcomes measured by the Western Ontario Shoulder Instability (WOSI) score. Patients operated on within the past 1-8 years will be included. Data will be collected through structured telephone interviews and medical record reviews.
Read the detailed description
Background Chronic recurrent shoulder dislocation presents a significant challenge in orthopedic surgery, with potential long-term consequences for patients' functionality and quality of life. Arthroscopic stabilization using a bone block harvested from the iliac crest, without screw fixation, is a relatively new technique designed to reduce the risk of recurrence by improving the anatomical integrity of the shoulder joint.
Indications for shoulder stabilization surgery with a bone graft, also known as the bone block procedure, are based on classical criteria considering both anatomical and functional aspects of shoulder instability. These criteria include recurrent anterior shoulder dislocations that do not respond to conservative treatment such as physical therapy, significant glenoid bone loss, Hill-Sachs lesions, or failed previous stabilization surgery, such as a Bankart repair, where patients continue to experience instability or recurrent dislocations. Bone block stabilization may also be indicated in patients with particularly high demands for shoulder function and stability, such as those engaged in activities or occupations with a high risk of shoulder dislocation.
The bone block procedure addresses these issues by transferring a segment of bone from the iliac crest to the glenoid defect, thereby increasing the articular surface area. Simultaneously, the anterior joint capsule is tightened and reinforced, and the infraspinatus tendon is secured into the Hill-Sachs defect (remplissage) to enhance shoulder stability. This procedure is typically performed when more conservative methods have failed to provide adequate stability or when the anatomical conditions of the shoulder suggest that other techniques are unlikely to yield satisfactory results.
This study aims to evaluate the long-term outcomes of this surgical method.
Objective The primary objective of this study is to evaluate the clinical outcomes of patients undergoing arthroscopic shoulder stabilization with a bone block for chronic recurrent shoulder dislocations. The focus will be on complications, reoperations, and functional outcomes assessed using the Western Ontario Shoulder Instability Index (WOSI).
Methods and Study Design This study will be a retrospective cohort study including patients who have undergone arthroscopic shoulder stabilization using the bone block technique.
Recruitment and Informed Consent Eligible patients will be identified through searches in electronic medical records. Patients will first receive an information letter about the study, followed by a phone call 1-2 weeks later, providing an opportunity to ask questions. If the patient consents to participate, a digital consent form will be sent. Once the patient has signed the consent form digitally, a follow-up phone interview will be scheduled to complete a structured questionnaire assessing functional outcomes and quality of life.
Data Collection Data will be collected through structured telephone interviews focusing on postoperative complications, reoperations, and functional outcomes. Additionally, medical records will be reviewed to obtain relevant operative details and preoperative data. Data collection will be conducted by independent observers.
Statistical Analysis Descriptive statistics will summarize patient characteristics, complications, and functional scores.
Paired t-tests or Wilcoxon rank-sum tests will compare pre- and postoperative WOSI and EQ-5D-5L scores.
Chi-square or Fisher's exact test will be used to analyze categorical data such as complication or reoperation rates.
Correlation and regression analyses will examine predictors of functional outcomes.
Statistical significance will be set at p < 0.05.
Ethical Considerations The study will be conducted in compliance with the Declaration of Helsinki and will require approval from the Regional Ethics Committee (REK) and the local institutional review board (PVO). All participants will provide informed consent, and patient data will be anonymized to ensure confidentiality.
Study Timeline The study is expected to commence in Fall 2024 and will run for approximately two years, with data collection and analysis planned from 2024 to 2026. Results will be published in peer-reviewed journals and presented at relevant orthopedic conferences.
- Conditions
- Shoulder Instability
- Keywords
- shoulder instability, recurrence, Latarjet, arthroscopy, bone block
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence of shoulder instability (measured through patient-reported dislocation episodes).
Measured: From the index surgery to the time of the telephone interview, which may be up to 10 years.
Secondary outcomes (3)
Postoperative complications
Postoperative complications (documented in medical records and patient interviews).
Measured: From the index surgery to the time of the telephone interview, which may be up to 10 years.
WOSI score
Functional shoulder outcomes assessed by the WOSI score.
Measured: At the time of the telephone interview, which may be up to 10 years after the index surgery.
HRQoL
Health-related quality of life evaluated using EQ-5D-5L.
Measured: At the time of the telephone interview, which may be up to 10 years after the index surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Reidar Høiness, MD Phd, Principal investigator, Vestre Viken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920654
- Sponsor's protocol ID
- 774617
- Status last verified
- May 2025
- First submitted
- 26 Mar 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization of the Shoulder Joint Using a Latarjet-like Procedure.
- ClinicalTrials.gov ID
- NCT06920654
- Acronym / sponsor ID
- 774617
- Conditions
- Shoulder Instability
- Keywords
- shoulder instability, recurrence, Latarjet, arthroscopy, bone block
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
This retrospective cohort study aims to evaluate the clinical outcomes of patients who underwent arthroscopic shoulder stabilization using a bone block technique for chronic recurrent shoulder dislocations. The study will assess complications, reoperations, and functional outcomes measured by the Western Ontario Shoulder Instability (WOSI) score. Patients operated on within the past 1-8 years will be included. Data will be collected through structured telephone interviews and medical record reviews.
Detailed description
Background Chronic recurrent shoulder dislocation presents a significant challenge in orthopedic surgery, with potential long-term consequences for patients' functionality and quality of life. Arthroscopic stabilization using a bone block harvested from the iliac crest, without screw fixation, is a relatively new technique designed to reduce the risk of recurrence by improving the anatomical integrity of the shoulder joint.
Indications for shoulder stabilization surgery with a bone graft, also known as the bone block procedure, are based on classical criteria considering both anatomical and functional aspects of shoulder instability. These criteria include recurrent anterior shoulder dislocations that do not respond to conservative treatment such as physical therapy, significant glenoid bone loss, Hill-Sachs lesions, or failed previous stabilization surgery, such as a Bankart repair, where patients continue to experience instability or recurrent dislocations. Bone block stabilization may also be indicated in patients with particularly high demands for shoulder function and stability, such as those engaged in activities or occupations with a high risk of shoulder dislocation.
The bone block procedure addresses these issues by transferring a segment of bone from the iliac crest to the glenoid defect, thereby increasing the articular surface area. Simultaneously, the anterior joint capsule is tightened and reinforced, and the infraspinatus tendon is secured into the Hill-Sachs defect (remplissage) to enhance shoulder stability. This procedure is typically performed when more conservative methods have failed to provide adequate stability or when the anatomical conditions of the shoulder suggest that other techniques are unlikely to yield satisfactory results.
This study aims to evaluate the long-term outcomes of this surgical method.
Objective The primary objective of this study is to evaluate the clinical outcomes of patients undergoing arthroscopic shoulder stabilization with a bone block for chronic recurrent shoulder dislocations. The focus will be on complications, reoperations, and functional outcomes assessed using the Western Ontario Shoulder Instability Index (WOSI).
Methods and Study Design This study will be a retrospective cohort study including patients who have undergone arthroscopic shoulder stabilization using the bone block technique.
Recruitment and Informed Consent Eligible patients will be identified through searches in electronic medical records. Patients will first receive an information letter about the study, followed by a phone call 1-2 weeks later, providing an opportunity to ask questions. If the patient consents to participate, a digital consent form will be sent. Once the patient has signed the consent form digitally, a follow-up phone interview will be scheduled to complete a structured questionnaire assessing functional outcomes and quality of life.
Data Collection Data will be collected through structured telephone interviews focusing on postoperative complications, reoperations, and functional outcomes. Additionally, medical records will be reviewed to obtain relevant operative details and preoperative data. Data collection will be conducted by independent observers.
Statistical Analysis Descriptive statistics will summarize patient characteristics, complications, and functional scores.
Paired t-tests or Wilcoxon rank-sum tests will compare pre- and postoperative WOSI and EQ-5D-5L scores.
Chi-square or Fisher's exact test will be used to analyze categorical data such as complication or reoperation rates.
Correlation and regression analyses will examine predictors of functional outcomes.
Statistical significance will be set at p < 0.05.
Ethical Considerations The study will be conducted in compliance with the Declaration of Helsinki and will require approval from the Regional Ethics Committee (REK) and the local institutional review board (PVO). All participants will provide informed consent, and patient data will be anonymized to ensure confidentiality.
Study Timeline The study is expected to commence in Fall 2024 and will run for approximately two years, with data collection and analysis planned from 2024 to 2026. Results will be published in peer-reviewed journals and presented at relevant orthopedic conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who underwent arthroscopic shoulder stabilization with a bone block technique at a single orthopedic center. Approximately 40-50 patients are expected to be included, with a retrospective follow-up period of 1-10 years postoperatively.
Key inclusion criteria (3 listed)
- Patients who underwent surgery for chronic recurrent shoulder dislocations.
- Surgery performed between 1-10 years before study inclusion.
- Patients aged 18 years or older who provide informed consent.
Key exclusion criteria (4 listed)
- Patients with other concurrent shoulder surgeries unrelated to bone block stabilization.
- Patients with major orthopedic conditions affecting the study outcome.
- Patients with insufficient follow-up data.
- Patients who do not provide informed consent.
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
Recurrence
Time frame: From the index surgery to the time of the telephone interview, which may be up to 10 years.
Recurrence of shoulder instability (measured through patient-reported dislocation episodes).
3 secondary outcomes
Postoperative complications
Time frame: From the index surgery to the time of the telephone interview, which may be up to 10 years.
WOSI score
Time frame: At the time of the telephone interview, which may be up to 10 years after the index surgery.
HRQoL
Time frame: At the time of the telephone interview, which may be up to 10 years after the index surgery.
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 25 May 2025.
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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.
Per Reidar Høiness, MD Phd principal investigator
Vestre Viken HF
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 Shoulder Instability, run by Vestre Viken Hospital Trust 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 25 May 2025. 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?
Recurrence (time frame: From the index surgery to the time of the telephone interview, which may be up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.