Shoulder InstabilityNCT03331510
Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet
An observational study of Shoulder Instability, run by Etzel Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Instability
- What is being tested?
- Strength testing before and after arthroscopic Latarjet
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Instability
- Being tested
- Strength testing before and after arthroscopic Latarjet
- Keywords
- Shoulder, Instability, Latarjet, Dislocation, Strength
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength testing before and after arthroscopic LatarjetOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
Stability
Stability of the operated shoulder is evaluated objectively and subjectively utilising different specific scores.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startFeb 2018 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etzel Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Smolen, MD, Etzel Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331510
- Sponsor's protocol ID
- Prospective Strength Latarjet
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To discuss and evaluate results as well as drafting the manuscript, IPD might be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered
- ClinicalTrials.gov ID
- NCT03331510
- Acronym / sponsor ID
- Prospective Strength Latarjet
- Conditions
- Shoulder Instability
- Keywords
- Shoulder, Instability, Latarjet, Dislocation, Strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Etzel ClinicUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength testing before and after arthroscopic LatarjetAfter 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. | Other | – |
Primary outcome
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.
2 secondary outcomes
Range of Motion
Time frame: 24 months
Stability
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: Yes. To discuss and evaluate results as well as drafting the manuscript, IPD might be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Instability, run by Etzel Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.