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Clinical Trials/NCT03331510
NCT03331510
Unknown
Not Applicable

Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered

Etzel Clinic0 sites50 target enrollmentFebruary 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Instability
Sponsor
Etzel Clinic
Enrollment
50
Primary Endpoint
Strength
Last Updated
8 years ago

Overview

Brief Summary

Open and arthroscopic Latarjet procedures are used to treat shoulder instability as primary and salvage procedures. During surgery the coracoid process is detached and repositioned to the anterior glenoid through a subscapularis split and fixed in place, resulting in an enlarged glenoid and therefor articular surface. However, before this is done, the pectorals minor, which inserts at the coracoid process, has to be detached and is left without further treatment. Moreover, the conjoint tendon, the origin of the short head of the biceps and coracobrachialis, is repositioned with the coracoid and therefor distalized and medialized.

No study currently followed up on the strength of the muscles altered. The aim of this study is therefor, to prospectively measure range of motion and strength of the operated shoulder at different time points pre- and postoperatively, comparing it with the healthy shoulder in each individual.

Detailed Description

Strength, range of motion and stability will be assessed pre-operatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months post-operatively. Next to standard radiological follow up, including X-ray, arthrographic computed tomography as well as arthrographic magnetic resonance imaging, specific shoulder scores will be utilised. Strength for general shoulder motion as well as specifically for the subscapularis, the pectorals minor, the coracobrachialis and the biceps will be measured with a shoulder dynamometer. Data will be analysed and published.

Registry
clinicaltrials.gov
Start Date
February 2018
End Date
December 2022
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Etzel Clinic
Responsible Party
Principal Investigator
Principal Investigator

Daniel Smolen, MD

MD

Etzel Clinic

Eligibility Criteria

Inclusion Criteria

  • Patients who experienced at least one shoulder dislocation.
  • Patients who are willing to participate in the study
  • Patients who receive arthroscopic Latarjet procedure for treatment of glen-humeral instability
  • Patients who are at least 18 years old.
  • Patients with an ISI-Score of at least 4 points.

Exclusion Criteria

  • Patients older than 50 or younger than 18 years of age.
  • Patients with painful unstable (multidirectional) instability
  • Patients with congenital defects of the bones involved (humerus, scapula).
  • Patients with an ISIS of smaller 4 points.

Outcomes

Primary Outcomes

Strength

Time Frame: 24 months

Strength for different muscles involved in shoulder movement is measured pre- and post-operatively for the operated shoulder and the contralateral side. Strength will be measured in Kilogramm with a shoulder dynamometer. Scale range is assumed to be between 0 and 25 kg, higher values postoperatively indicate better outcome. Measurements will be undertaken for the subscapularis in internal rotation at 0 and 90 degrees; for the muscles attached to the conjoint tendon (short head of the biceps and coracobrachialis) in 45 degree shoulder flexion, while resistance will be applied on the flexing forearm. The pectoralis minor measurment will be undertaken through applying pressure against the protracting shoulder. Furthermore, standard strength measurements will be undertaken in 90 degree shoulder flexion and abduction, applying resistance against the hand, and in 0 degree internal as well as external rotation with a flexed elbow.

Secondary Outcomes

  • Range of Motion(24 months)
  • Stability(24 months)

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