Clinical trial NCT03331510: Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet
Official title: Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Instability
Keywords: Shoulder, Instability, Latarjet, Dislocation, Strength
Lead sponsor: Etzel Clinic
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with shoulder instability or shoulder dislocations, treated with arthroscopic Latarjet at the Etzelclinic will be enrolled in consideration of the inclusion and exclusion criteria.

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.

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.

Primary outcomes:
measure: Strength
timeFrame: 24 months
Secondary outcomes:
measure: Range of Motion
timeFrame: 24 months
measure: Stability
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: