Anterior Shoulder DislocationNCT03693716
Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps
A study testing Dynamic Anterior Stabilization in people with Anterior Shoulder Dislocation and Bankart Lesion, run by Hospital de Egas Moniz at 1 site in Portugal.
Trial summary
Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Shoulder Dislocation, Bankart Lesion, Hill Sachs Lesion
- What is being tested?
- Dynamic Anterior Stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Sep 2018to 31 Dec 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging
- one or more traumatic anterior shoulder dislocation episodes
- contact or forced overhead sport or work activity
Who cannot join
- proximal humerus fracture
- rotator cuff tear requiring repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results
Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.
Read the detailed description
Patients with a history of traumatic anterior shoulder dislocations with documented imagological Bankart and HillSachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. All patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant, ROWE and WOSI scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). All continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (Mann-Whitney U test). All categorical variables and outcome results will be compared between the two groups (Fisher's exact test). A significant difference will be defined as P<0.05.
- Being tested
- Dynamic Anterior Stabilization
- Keywords
- Transsubscapular, Long head of the biceps tendon, LHBT, Anterior Shoulder Dislocation, Bankart, HillSachs, Arthroscopic Anterior Dynamic Stabilization
- Medical subject headings
- Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Anterior StabilizationProcedure or surgery
All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Anterior Stabilization | Experimental | Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis Receives: Procedure: Dynamic Anterior Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion (ROM)
Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.
Measured: 2 years
Secondary outcomes (3)
Shoulder Strength
minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.
Measured: 2 years
The ROWE score
0 -100 points: Section 1 - Stability No Recurrence, subluxation or apprehension (50 points) Apprehension when placing arm in certain positions (30 points) Subluxation (not requiring reduction) (10 points) Recurrent Dislocation (0 points)
Section 2 - Motion 100% of normal ext rotation, int rotation and elevation (20 points) 75% of normal ext rotation, int rotation and elevation (15 points) 50% of normal ext rotation, int rotation and elevation (5 points) 50% of normal elevation, and int rotation, No ext rotation (0 points)
Section 3 - Function No limitation of work or sports, little or no discomfort (eg shoulder strong overhead, lifting, swimming, throwing, tennis) (30 points)
Mild limitation and minimum discomfort (25 points) Moderate limitation and discomfort (10 points) Marked limitation and pain (0 points) For every scale range provided, higher values represent a better outcome.
Measured: 2 years
The Western Ontario Shoulder Instability Index (WOSI)
0-2100 (0-100%), the WOSI score instrument (Kirkley et al. 1998) consists of 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100; for every scale range provided, higher values represent a worse outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start20 Sep 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Shoulder DislocationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Egas Moniz
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental
- Responsible party
- Principal investigator, Clara Isabel de Campos Azevedo, Hospital de Egas Moniz
- Investigators
- Clara Azevedo, MD, Principal investigator, Centro Hospitalar de Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693716
- Sponsor's protocol ID
- 01-2018-09HSFX
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.
PubMed 624747Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
PubMed 9850776de Campos Azevedo C, Angelo AC. All-Suture Anchor Dynamic Anterior Stabilization Produced Successful Healing of the Biceps Tendon: A Report of 3 Cases. JBJS Case Connect. 2021 Feb 17;11(1). doi: 10.2106/JBJS.CC.20.00149.
PubMed 33599463
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results
- ClinicalTrials.gov ID
- NCT03693716
- Acronym / sponsor ID
- 01-2018-09HSFX
- Keywords
- Transsubscapular, Long head of the biceps tendon, LHBT, Anterior Shoulder Dislocation, Bankart, HillSachs, Arthroscopic Anterior Dynamic Stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital de Egas MonizUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Oct 2018 (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.
Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.
Detailed description
Patients with a history of traumatic anterior shoulder dislocations with documented imagological Bankart and HillSachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. All patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant, ROWE and WOSI scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). All continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (Mann-Whitney U test). All categorical variables and outcome results will be compared between the two groups (Fisher's exact test). A significant difference will be defined as P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Anterior Stabilization | Experimental | Procedure: Dynamic Anterior StabilizationArthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging
- one or more traumatic anterior shoulder dislocation episodes
- contact or forced overhead sport or work activity
Key exclusion criteria (2 listed)
- proximal humerus fracture
- rotator cuff tear requiring repair
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 |
|---|---|---|
| Dynamic Anterior StabilizationAll-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors | Procedure or surgery | Dynamic Anterior Stabilization |
Primary outcome
Shoulder range of motion (ROM)
Time frame: 2 years
Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.
3 secondary outcomes
Shoulder Strength
Time frame: 2 years
The ROWE score
Time frame: 2 years
The Western Ontario Shoulder Instability Index (WOSI)
Time frame: 2 years
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 28 Feb 2023.
- Results publication: PubMed 624747Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.
- Results publication: PubMed 9850776Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
- Derived from this study: PubMed 33599463de Campos Azevedo C, Angelo AC. All-Suture Anchor Dynamic Anterior Stabilization Produced Successful Healing of the Biceps Tendon: A Report of 3 Cases. JBJS Case Connect. 2021 Feb 17;11(1). doi: 10.2106/JBJS.CC.20.00149.
- 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.
Clara Azevedo, MD principal investigator
Centro Hospitalar de Lisboa Ocidental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Anterior Stabilization in people with Anterior Shoulder Dislocation and Bankart Lesion, run by Hospital de Egas Moniz at 1 site in Portugal.
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 2 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 28 Feb 2023. 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 Portugal. 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?
Shoulder range of motion (ROM) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693716, which also lists 3 linked publications.
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 28 Feb 2023.