ClinConnect ClinConnect Logo
Search / Trial NCT06157229

Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair

Launched by SPAARNE GASTHUIS · Nov 27, 2023

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the recovery outcomes for patients who have undergone surgery to fix a specific type of shoulder injury called an anterior shoulder dislocation. After surgery, participants will be divided into two groups: one will follow standard rehabilitation guidelines, while the other group will receive a special training program designed to help reduce fear of movement and anxiety about future shoulder dislocations. The goal is to see which approach leads to better recovery and overall function of the shoulder.

To be eligible for this study, participants must be between 18 and 67 years old and have experienced a traumatic shoulder dislocation confirmed by an MRI. They need to be able to understand Dutch and provide written consent to participate. Unfortunately, individuals with certain conditions, like multiple shoulder instability or significant anxiety disorders, won't be able to join. If you decide to participate, you can expect to follow either the standard rehabilitation program or the new training approach after your surgery, helping you regain strength and confidence in your shoulder.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)
  • Aged between 18-67 years
  • Planned arthroscopic Bankart repair (ABR) surgery
  • Understanding of spoken and written Dutch language
  • Written informed consent (according to the ICH-GCP guidelines)
  • Positive apprehension sign at physical examination
  • Exclusion Criteria:
  • Posterior or multidirectional shoulder instability
  • Presence of hyperlaxity of the upper extremity and absence of sulcus sign and \>85 degrees of external rotation with the arm at the side at physical examination
  • Connective tissue disorders (e.g. Ehlers-Danlos)
  • Aged \<18 or \>67 years
  • Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)
  • History of soft tissue repair or bone block procedure on one of both shoulders
  • Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)
  • Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)
  • Neurological disorders or systemic disease
  • Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder
  • Hill-Sachs lesion visible on external rotation radiographs
  • Greater tubercle fracture

About Spaarne Gasthuis

Spaarne Gasthuis is a leading healthcare institution in the Netherlands, dedicated to providing high-quality medical care and advancing clinical research. With a focus on patient-centered approaches, the hospital conducts a diverse range of clinical trials across various medical specialties, aiming to enhance treatment options and improve patient outcomes. Spaarne Gasthuis is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and well-being of trial participants while contributing to the advancement of medical knowledge and innovation. Through collaboration with academic institutions and industry partners, Spaarne Gasthuis continues to play a pivotal role in the development of new therapies and healthcare solutions.

Locations

Patients applied

0 patients applied

Trial Officials

Arthur van Noort, MD PhD

Principal Investigator

Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported