Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet

Shoulder Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03331510
• Other study ID #: Prospective Strength Latarjet
• Status: Not yet recruiting
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 30, 2017
• Start date: February 2018
• Est. completion date: December 2022

Study information

• Verified date: November 2017
• Source: Etzel Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: January 2022
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Instability

Intervention

Other:
• Strength testing before and after arthroscopic Latarjet
After patients, based on the ISI-Score, were assigned to treat their shoulder instability with an arthroscopic Latarjet procedure, they are eligible for this study. Strength of different involved muscles, as well as ROM will be measured before and at several time points after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Etzel Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength	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.	24 months
Secondary	Range of Motion	Range of Motion of the operated shoulder and the contralateral side is measured pre-and post-operatively. Outcome measure will be in degree of range of motion, with higher numbers indicating greater range of motion.	24 months
Secondary	Stability	Stability of the operated shoulder is evaluated objectively and subjectively utilising different specific scores.	24 months