- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331510
Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet
Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: 24 months
|
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
|
Stability
Time Frame: 24 months
|
Stability of the operated shoulder is evaluated objectively and subjectively utilising different specific scores.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Prospective Strength Latarjet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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