An observational study in Shoulder Dislocation, sponsored by Catarina Malmberg. Completed at 1 site in Denmark. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Catarina Malmberg · Observational
The purpose of the study is to investigate biomechanical and proprioceptive conditions in patients with symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair. To determine these, non-invasive and non-irradiating examination methods that have been proven valid and reliable will be used in a combination that has not been reported before. The objective is to determine whether the anatomical reconstruction affects biomechanical and proprioceptive measures in the traumatic unstable shoulder. The study will also investigate patient-reported and clinical outcomes.
The hypotheses are that the intervention improves biomechanical and proprioceptive conditions to the near-normal state, as measured after both 6 and 12 months. Further, hypotheses are that the intervention leads to improved patient-reported and clinical outcomes.
Hypotheses:
Scapular rotations and tilt remain unchanged after arthroscopic Bankart repair.
In patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair, to investigate the neuromuscular control before and six and twelve months after surgery and whether the neuromuscular control is restored to the same level as the non-injured contralateral shoulder.
Hypotheses:
Arthroscopic Bankart repair improves neuromuscular control to the same range as the non-injured shoulder.
In patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair:
To investigate if there are correlations between a) the shoulder biomechanics and b) the neuromuscular control, and PROM, ROM, and bone loss, respectively.
Multi-clinical prospective cohort study including 30 patients. Patients' contralateral shoulders will be used as controls.
The sample size calculation is made to allow for assessment of the primary outcomes within each category of outcomes; For research question A concerning biomechanics, the study is powered to detect a mean change in anterior-posterior glenohumeral translation of ≥2.5 mm with a standard deviation (SD) of 2.3 mm. For research question B concerning neuromuscular control, the study is powered to detect an effect size of 0.8 for change in reaction time. For the clinical and patient-reported outcomes, the study is powered to detect an effect size of 0.8 for the WOSI score.
For power of 90% and type I error rate of 0.017 (0.05/3), correcting for three tests, sample size for a one-sample t-test is 15, 24 and 24 for anterior-posterior glenohumeral translation, reaction time and WOSI score, respectively. As such, the largest sample size of 24 will be used. To account for expected dropout rate of 25% a total of 30 patients will be included.
Originally, the study was powered to detect a between group difference in anterior-posterior glenohumeral translation of ≥2.5 mm with a standard deviation (SD) of 2.3 mm, and a power of 80%. With six variables in the analysis (sex, height, BMI, dominant/non-dominant side affected, bone loss, clinical score) and an estimated 15% dropout rate, the calculation resulted in 55 patients. During the writing of a protocol article, it was realized that since the same shoulders are compared pre and post intervention no between groups analysis is performed and hence the setup controls for the six mentioned variables in itself. The sample size was thus re-calculated as stated above.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's enrollment of 26 is below the median of 86 across 28 observational studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →This is the only study on the registry with Catarina Malmberg as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients aged 18-40 years with unilateral symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair
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.
Patients aged 18-40 years with symptomatic unilateral traumatic anterior shoulder instability, following radiographically confirmed or manually reduced dislocation (first-time or recurrent), scheduled for arthroscopic Bankart repair, and with no pathology in the contralateral shoulder. The study is not interventional but observational, examining biomechanical and proprioceptive conditions in patients' unstable shoulders before and after the surgical procedure.
Procedure: Arthroscopic Bankart repair
Arthroscopic Bankart repair is a minimally invasive surgical procedure with the aim to reattach and tighten the detached labrum and ligaments within the shoulder joint.
Change in anterior-posterior glenohumeral translation (range in millimeters)
The effect of Bankart repair on anterior-posterior glenohumeral translation, measured 6 months after intervention and compared to pre-interventional. The translation will be measured using ultrasound examination.
Time frame: baseline, 6 months
Change in anterior-posterior glenohumeral translation (range in millimeters)
Longer-term effects of Bankart repair on anterior-posterior glenohumeral translation, as measured 12 months after intervention and compared to pre-interventional. The translation will be measured using ultrasound examination.
Time frame: baseline, 12 months
Change in neuromuscular control (as assessed with the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol).
The effect of Bankart repair on neuromuscular control at 6 and 12 months after intervention and compared to pre-interventional. Neuromuscular control will be assessed using the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol.
Time frame: baseline, 6 months, 12 months
Change in superior-inferior glenohumeral translation (range in millimeters)
Effects of Bankart repair on superior-inferior glenohumeral translation, measured 6 and 12 months after intervention and compared to pre-interventional.
Time frame: baseline, 6 months, 12 months
Change in scapular rotations (degrees)
Effects of Bankart repair on scapular rotations, measured 6 and 12 months after intervention and compared to pre-interventional.
Time frame: baseline, 6 months, 12 months
Instability tests
The effect of Bankart repair on clinical instability tests: sulcus sign, load and shift, apprehension test and relocation test.
Time frame: baseline, 6 months, 12 months
Change in Western Ontario Shoulder Instability (WOSI) Index
The Western Ontario Shoulder Instability (WOSI) Index is a patient-reported outcome measure (PROM). It consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (best possible score - the patient is experiencing no decrease in shoulder-related quality of life) to 2100 (worst score - signifies extreme distress in shoulder-related quality of life).
Time frame: baseline, 6 months, 12 months
Change in EQ-5D(-5L) questionnaire on quality of life
The EQ-5D-5L questionnaire on quality of life is a patient-reported outcome measure (PROM), with five components, which assess the severity of problems in three functional dimensions (mobility, self-care, and usual activities) and two somatic symptom dimensions (pain/discomfort and anxiety/depression). The response scales consist of a heading and five short statements, each describing a different level of severity within the dimensions.
Time frame: baseline, 6 months, 12 months
Change in degrees of shoulder range of motion
Range of motion will be assessed clinically as degrees from anatomical position in the following planes: flexion, extension, scaption, internal and external rotation.
Time frame: baseline, 6 months, 12 months
Bone loss
A pre-surgical computed tomography (CT) scan to measure potential bone loss. Glenoid bone loss is measured using the PICO-method, which is based on calculating the size of the defect as the percentage of a best-fit circle from the contralateral glenoid. The size (the largest height, width and depth in millimeters) of Hill-Sachs lesions on the humeral head is also measured and registered, but not the specific location.
Time frame: baseline
Recurrent events
Any radiographically confirmed or manually reduced dislocations in the first twelve months are registered during follow-up
Time frame: 6 months, 12 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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