Status:
NOT_YET_RECRUITING
Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
Lead Sponsor:
Spaarne Gasthuis
Collaborating Sponsors:
OLVG
Ziekenhuis Amstelland
Conditions:
Shoulder Instability
Shoulder Dislocation or Subluxation
Eligibility:
All Genders
18-67 years
Phase:
NA
Brief Summary
This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation, following the American Society...
Detailed Description
Background: Fear for (recurrent) dislocation is a frequently reported patient perception regarding the treatment of anterior shoulder instability and is associated with poor outcomes like decrease in ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06157229
Start Date
January 1 2024
End Date
June 1 2027
Last Update
December 5 2023
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