SurgerySSM-SINCT06154460
The Effects of Different Surgical Stabilization Methods in Recurrent Anterior Shoulder Instability
An observational study of Surgery and Anterior Shoulder Instability, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Anterior Shoulder Instability
- What is being tested?
- Laterjet Surgery, Reimplissage Surgery and Capsular Reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2023to 29 Jun 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample of the study will consist of individuals who have undergone surgery in the Department of Orthopedics and Traumatology of Dokuz Eylül University Hospital due to instability diagnosis and who have returned to their activities of daily living. The research groups will consist of 30 patients with at least 10 patients each for 3 different surgical methods. These methods will be compared with each other in terms of pain, proprioceptive sensation, functional status and muscle activation. According to the reviewed studies, the number of individuals to be included in the study was determined as 30 individuals in total, 10 in each group.
Who may be able to join
- 18 years of age or older,
- At least 4 months after surgery,
- Not having any diagnosed neurological problem
Who cannot join
- Having an additional diagnosis that would cast doubt on the assessments (rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric disorders, etc.),
- Pregnancy status or suspicion
- Having undergone a different surgery such as a fracture with instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Surgical Stabilization Methods for Recurrent Anterior Shoulder Instability in Terms of Pain, Proprioceptive Sense, Functional Status, and Muscle Activation
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. Conservative and surgical treatments of instability are available. There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported.Therefore, the aim of this study was to compare different surgical stabilization methods in terms of pain, proprioceptive sensation, functional status and muscle activation in recurrent anterior shoulder instability, which is very common in adults.
Read the detailed description
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. It is more common in young males. While damage is limited to the capsule and labrum in most instabilities seen in young people, rotator cuff tear is also observed in 89% of those over 40 years of age. Trauma is the main cause of shoulder instability. While 96% of shoulder instabilities develop as a result of a blow to the arm in abduction or external rotation of the shoulder with excessive flexion, approximately 4% occur without trauma. Anterior instability occurs when the shoulder is forced into abduction and external rotation by impact, and posterior instability occurs when the shoulder in slight flexion and adduction is hit. The glenohumeral joint is an unstable joint because the depth and size of the glenoid fossa are not fully compatible with the humerus and as a result, the range of motion is wider compared to other joints in the body. While articular surface congruence, articular version, glenoid labrum, capsule and ligaments constitute static factors in ensuring stability; rotator cuff, biceps tendon, intra-articular negative pressure and muscles that form scapulothoracic movements (Trapezoid, Serratus Anterior, Rhomboids, Latissimus Dorsi) constitute dynamic factors. Insufficiency of one or more of these structures causes instability. Conservative and surgical treatments of instability are available. Conservative treatment includes nonoperative methods. These methods consist of electrophysical agents, heat-light agents, exercise and manual treatment methods and proceed through a certain protocol according to the patient's condition and symptoms. In cases where medical and physical therapies are not sufficient, surgical treatment procedures are initiated.
Reimplisasagge, capsular reconstruction and laterjet methods are commonly used in surgical treatments. Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect. The possibility of loss of internal and external rotation as a result of infraspinatus tendon transfer after reimplissage is a matter of debate. Allografts or autografts are used for capsular reconstruction, which is another surgical method. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted. The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported. Therefore, the aim of our study was to compare these commonly applied methods in terms of pain, proprioceptive sensation, functional status and muscle activation and the hypothesis of the study was as follows; Hypothesis of the Study: Laterjet, reimplissage and capsular reconstruction surgical procedures in recurrent anterior shoulder instabilities affect pain, proprioceptive sensation, functional status and muscle activation differently.
- Conditions
- Surgery, Anterior Shoulder Instability
- Being tested
- Laterjet Surgery, Reimplissage Surgery, Capsular Reconstruction
- Keywords
- Joint Instability, Shoulder Joint, Orthopedic Procedurs, Shoulder Pain, Proprioception, Functional Status, Electromyography
- Medical subject headings
- Joint Instability, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laterjet SurgeryProcedure or surgery
Also called LS
The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
Reimplissage SurgeryProcedure or surgery
Also called RS
Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect.
Capsular ReconstructionProcedure or surgery
Also called CR
Allografts or autografts are used for capsular reconstruction. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted
| Study group | Role | What they receive |
|---|---|---|
| Laterjet Surgery Group | This group will consist of individuals who underwent laterjet surgery. Receives: Procedure: Laterjet Surgery | |
| Reimplissage Surgery Group | This group will consist of individuals who underwent reimplissage surgery. Receives: Procedure: Reimplissage Surgery | |
| Capsular Reconstruction Surgery Group | This group will consist of individuals who underwent capsular reconstruction surgery. Receives: Procedure: Capsular Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Pain will be assessed by visual analog scale (VAS). A 10 cm horizontal line will be used for this. '0' means no pain and '10' means the worst possible pain
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of proprioceptive sensation
Positioning test will be used for the evaluation of proprioceptive sensation. Evaluation scores are calculated as the proportion of correct responses for repositioning.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of Range of Motion
A universal goniometer will be used for normal range of motion assessment. The normal limits of active range of motion are considered to be 180° for shoulder flexion, 180° for shoulder abduction, 90° for shoulder external rotation and 70-90° for shoulder internal rotation.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of Hand Grip Strength
Hand grip strength will be assessed with jamar hand dynamometer. In the test procedure, 3 measurements are made for hand grip and finger grip strengths with one-minute intervals between each measurement and the averages are recorded. High values mean high grip strength.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of functional status
DASH (Disability Arm Shoulder and Hand) questionnaire will be used. Each item has 5 response options ranging from 'no difficulty or no symptoms' to 'unable to perform the activity or very severe symptom' and is scored on a scale of 1 to 5 points. A scale score ranging from 0 (no disability) to 100 (most severe disability) is calculated.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of Shoulder Instability
WOSI (Western Ontario Shoulder Instability Index) will be used. The WOSI is a 21-item questionnaire used for patients with shoulder instability. Each question results in a number between 0 and 100 and the total score is presented as a number between 0 and 2100 points.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Assessment of Muscle Activation
Muscle activation will be evaluated by superficial EMG measurements. For this, the muscles with the best reaction around the shoulder joint were selected. These muscles were musculus infraspinatus, musculus middle deltoideus, musculus upper trapezius and musculus pectoralis major. The activation of the muscles will be evaluated during isometric contraction and during isotonic contractions performed in 3 different planes and results will be interpreted according to activation status. Data will be recorded during maximum voluntary isometric contraction (MVIC) and isotonic contraction (IC). During these contacts, the calculated "area" on the chart will be recorded. Additionally, the "IC/MVIC" percentage will be calculated to determine the workload on the muscle during the activity.
Measured: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start18 Dec 2023
- Primary completion10 May 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferruh Taşpınar, Izmir Democracy University
- Investigators
- Mustafa Özkan, Prof. Dr., Principal investigator, Dokuz Eylul UniversityBetul Taspinar, Prof. Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154460
- Sponsor's protocol ID
- SSM-SI-35
- Acronym
- SSM-SI
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Surgical Stabilization Methods for Recurrent Anterior Shoulder Instability in Terms of Pain, Proprioceptive Sense, Functional Status, and Muscle Activation
- ClinicalTrials.gov ID
- NCT06154460
- Acronym / sponsor ID
- SSM-SI / SSM-SI-35
- Conditions
- Surgery, Anterior Shoulder Instability
- Keywords
- Joint Instability, Shoulder Joint, Orthopedic Procedurs, Shoulder Pain, Proprioception, Functional Status, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 4 Dec 2023 (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.
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. Conservative and surgical treatments of instability are available. There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported.Therefore, the aim of this study was to compare different surgical stabilization methods in terms of pain, proprioceptive sensation, functional status and muscle activation in recurrent anterior shoulder instability, which is very common in adults.
Detailed description
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. It is more common in young males. While damage is limited to the capsule and labrum in most instabilities seen in young people, rotator cuff tear is also observed in 89% of those over 40 years of age. Trauma is the main cause of shoulder instability. While 96% of shoulder instabilities develop as a result of a blow to the arm in abduction or external rotation of the shoulder with excessive flexion, approximately 4% occur without trauma. Anterior instability occurs when the shoulder is forced into abduction and external rotation by impact, and posterior instability occurs when the shoulder in slight flexion and adduction is hit. The glenohumeral joint is an unstable joint because the depth and size of the glenoid fossa are not fully compatible with the humerus and as a result, the range of motion is wider compared to other joints in the body. While articular surface congruence, articular version, glenoid labrum, capsule and ligaments constitute static factors in ensuring stability; rotator cuff, biceps tendon, intra-articular negative pressure and muscles that form scapulothoracic movements (Trapezoid, Serratus Anterior, Rhomboids, Latissimus Dorsi) constitute dynamic factors. Insufficiency of one or more of these structures causes instability. Conservative and surgical treatments of instability are available. Conservative treatment includes nonoperative methods. These methods consist of electrophysical agents, heat-light agents, exercise and manual treatment methods and proceed through a certain protocol according to the patient's condition and symptoms. In cases where medical and physical therapies are not sufficient, surgical treatment procedures are initiated.
Reimplisasagge, capsular reconstruction and laterjet methods are commonly used in surgical treatments. Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect. The possibility of loss of internal and external rotation as a result of infraspinatus tendon transfer after reimplissage is a matter of debate. Allografts or autografts are used for capsular reconstruction, which is another surgical method. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted. The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported. Therefore, the aim of our study was to compare these commonly applied methods in terms of pain, proprioceptive sensation, functional status and muscle activation and the hypothesis of the study was as follows; Hypothesis of the Study: Laterjet, reimplissage and capsular reconstruction surgical procedures in recurrent anterior shoulder instabilities affect pain, proprioceptive sensation, functional status and muscle activation differently.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laterjet Surgery Group | – | Procedure: Laterjet SurgeryThis group will consist of individuals who underwent laterjet surgery. |
| Reimplissage Surgery Group | – | Procedure: Reimplissage SurgeryThis group will consist of individuals who underwent reimplissage surgery. |
| Capsular Reconstruction Surgery Group | – | Procedure: Capsular ReconstructionThis group will consist of individuals who underwent capsular reconstruction surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample of the study will consist of individuals who have undergone surgery in the Department of Orthopedics and Traumatology of Dokuz Eylül University Hospital due to instability diagnosis and who have returned to their activities of daily living. The research groups will consist of 30 patients with at least 10 patients each for 3 different surgical methods. These methods will be compared with each other in terms of pain, proprioceptive sensation, functional status and muscle activation. According to the reviewed studies, the number of individuals to be included in the study was determined as 30 individuals in total, 10 in each group.
Key inclusion criteria (3 listed)
- 18 years of age or older,
- At least 4 months after surgery,
- Not having any diagnosed neurological problem
Key exclusion criteria (3 listed)
- Having an additional diagnosis that would cast doubt on the assessments (rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric disorders, etc.),
- Pregnancy status or suspicion
- Having undergone a different surgery such as a fracture with instability.
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 |
|---|---|---|
| Laterjet SurgeryAlso: LSThe laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw. | Procedure or surgery | Laterjet Surgery Group |
| Reimplissage SurgeryAlso: RSReimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect. | Procedure or surgery | Reimplissage Surgery Group |
| Capsular ReconstructionAlso: CRAllografts or autografts are used for capsular reconstruction. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted | Procedure or surgery | Capsular Reconstruction Surgery Group |
Primary outcome
Assessment of pain
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Pain will be assessed by visual analog scale (VAS). A 10 cm horizontal line will be used for this. '0' means no pain and '10' means the worst possible pain
Assessment of proprioceptive sensation
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Positioning test will be used for the evaluation of proprioceptive sensation. Evaluation scores are calculated as the proportion of correct responses for repositioning.
Assessment of Range of Motion
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
A universal goniometer will be used for normal range of motion assessment. The normal limits of active range of motion are considered to be 180° for shoulder flexion, 180° for shoulder abduction, 90° for shoulder external rotation and 70-90° for shoulder internal rotation.
Assessment of Hand Grip Strength
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Hand grip strength will be assessed with jamar hand dynamometer. In the test procedure, 3 measurements are made for hand grip and finger grip strengths with one-minute intervals between each measurement and the averages are recorded. High values mean high grip strength.
Assessment of functional status
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
DASH (Disability Arm Shoulder and Hand) questionnaire will be used. Each item has 5 response options ranging from 'no difficulty or no symptoms' to 'unable to perform the activity or very severe symptom' and is scored on a scale of 1 to 5 points. A scale score ranging from 0 (no disability) to 100 (most severe disability) is calculated.
Assessment of Shoulder Instability
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
WOSI (Western Ontario Shoulder Instability Index) will be used. The WOSI is a 21-item questionnaire used for patients with shoulder instability. Each question results in a number between 0 and 100 and the total score is presented as a number between 0 and 2100 points.
Assessment of Muscle Activation
Time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Muscle activation will be evaluated by superficial EMG measurements. For this, the muscles with the best reaction around the shoulder joint were selected. These muscles were musculus infraspinatus, musculus middle deltoideus, musculus upper trapezius and musculus pectoralis major. The activation of the muscles will be evaluated during isometric contraction and during isotonic contractions performed in 3 different planes and results will be interpreted according to activation status. Data will be recorded during maximum voluntary isometric contraction (MVIC) and isotonic contraction (IC). During these contacts, the calculated "area" on the chart will be recorded. Additionally, the "IC/MVIC" percentage will be calculated to determine the workload on the muscle during the activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Mustafa Özkan, Prof. Dr. principal investigator
Dokuz Eylul University
Betul Taspinar, Prof. Dr. principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Anterior Shoulder Instability, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of pain (time frame: Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.). The study lists 7 primary outcomes in all. 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 9 Aug 2024.