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Trial record 4 of 10334 for:    strength

Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet

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ClinicalTrials.gov Identifier: NCT03331510
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Smolen, MD, Etzel Clinic

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.


Condition or disease Intervention/treatment
Shoulder Instability Other: Strength testing before and after arthroscopic Latarjet

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Stability [ Time Frame: 24 months ]
    Stability of the operated shoulder is evaluated objectively and subjectively utilising different specific scores.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.
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.

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Responsible Party: Daniel Smolen, MD, MD, Etzel Clinic
ClinicalTrials.gov Identifier: NCT03331510     History of Changes
Other Study ID Numbers: Prospective Strength Latarjet
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To discuss and evaluate results as well as drafting the manuscript, IPD might be shared with other researchers.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Smolen, MD, Etzel Clinic:
Shoulder, Instability, Latarjet, Dislocation, Strength