Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet

NCT03331510 | Unknown

• 1 other identifier: Prospective Strength Latarjet
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Instability

Keywords

Shoulder, Instability, Latarjet, Dislocation, Strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Range of Motion

  24 months

• Stability

  24 months

Interventions

Strength testing before and after arthroscopic Latarjet OTHER

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Etzel Clinic: lead

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: February 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: As soon as data of each patient involved is collected, it will possibly be shared with participating researchers and experienced advisors, until final manuscript is drafted.
• Access Criteria: Personal (eye to eye)