An observational study in Shoulder Instability, sponsored by Vestre Viken Hospital Trust. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Vestre Viken Hospital Trust · Observational
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.
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.
Vestre Viken Hospital Trust is the lead sponsor of 52 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recurrence
Recurrence of shoulder instability (measured through patient-reported dislocation episodes).
Time frame: From the index surgery to the time of the telephone interview, which may be up to 10 years.
Postoperative complications
Postoperative complications (documented in medical records and patient interviews).
Time frame: 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.
Time frame: 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.
Time frame: At the time of the telephone interview, which may be up to 10 years after the index surgery.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2025, 2 months after the start.
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Vestre Viken Hospital Trust