Shoulder DislocationNCT02535585
Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors
A study testing knotted anchors (SutureTak biocomposite 3.0 mm) and knotless anchors (PushLock biocomposite 2.9 mm knotless) in people with Shoulder Dislocation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- knotted anchors (SutureTak biocomposite 3.0 mm) and knotless anchors (PushLock biocomposite 2.9 mm knotless)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2017to 16 Jan 2021
- 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
- Skeletal maturity;
- Anterior glenohumeral instability;
- Previous labral lesion without bone defects or with defects that affect no more than 20% of the anteroposterior diameter of the glenoid, as shown by MRI;
- Instability severity index score (ISIS) < 4;
- Non-Inclusion Criteria
- Epilepsy;
Show all 10Show fewer
- Associated rotator cuff tear;
- Proximal humeral fracture;
- Multidirectional or posterior instability by clinical evaluation;
- Generalized ligamentous laxity by clinical evaluation;
Who cannot join
- Irreparable injury to the anterior capsule or injury to the humeral insertion of the inferior glenohumeral ligament;
- Glenoid bone defect greater than 20% of the anteroposterior diameter measured by arthroscopy;
- Rotator cuff tear found on arthroscopy;
- Abandonment of the rehabilitation program and follow-up before the first evaluation of outcomes
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-010
About this study
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs.
The researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
Read the detailed description
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. The overall incidence of first-time dislocations requiring closed reduction is 23.1 per 100,000 people/year, with a higher incidence in males and Caucasians. Individuals with a younger age at first dislocation show a higher rate of recurrence.
Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation, with similar outcomes to open repair. The technique is less aggressive because the tendon of the subscapularis does not need to be addressed, leading to shorter hospital stays, less scarring, earlier return to normal activities, and a greater postoperative range of motion.
In this technique, the glenoid labrum-ligament complex (GLLC) is repaired using bone anchors that can be metallic, absorbable, or flexible. Biomechanical studies have shown that these three types of anchors are similar in terms of cyclic loading resistance and bone fixation. Absorbable anchors are most frequently used because metallic anchors can cause postoperative imaging interference in MRI study, can migrate and became loose or break, which can damage the articular cartilage. Flexible anchors when submitted to cyclic stress can produce cystic cavities in bone tissue attachment 21, and probably can lead to a failure of glenoid labrum-ligament complex suture.
The most commonly used technique is the attachment of GLLC with knotted anchors. Studies have shown to perform an arthroscopic knot is challenging and can be technically difficult. The knot volume can produce friction during the shoulder movement, leading joint discomfort and cartilage damage. The quality of the soft tissue healing depend on the knot quality too. The dislocation recurrence rate with this technique ranges from 4% to 19%.
In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Although this new technique had solved the difficulty of tying knots, the results regarding the GLLC suture shown more gap formation between this complex and the glenoid bone, delayed anchor loosening and postoperative arthropathy. The recurrence rate is high associated with perianchor radiolucency.The recurrence rate with this technique is as high as 23.8%.
Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs.
Our researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
- Conditions
- Shoulder Dislocation
- Being tested
- knotted anchors (SutureTak biocomposite 3.0 mm), knotless anchors (PushLock biocomposite 2.9 mm knotless)
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knotted anchors (SutureTak biocomposite 3.0 mm)Device
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
knotless anchors (PushLock biocomposite 2.9 mm knotless)Device
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
| Study group | Role | What they receive |
|---|---|---|
| knotted anchors | Active comparator | Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm). Receives: Device: knotted anchors (SutureTak biocomposite 3.0 mm) |
| knotless anchors | Active comparator | Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless) Receives: Device: knotless anchors (PushLock biocomposite 2.9 mm knotless) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rowe scale
To compare, using the Rowe scale, clinical outcomes, at one year after surgery, of patients undergoing labral lesion suture using knotted anchors with those treated with knotless anchors.
Measured: 1 year
Secondary outcomes (9)
dislocation recurrence rate
To evaluate the postoperative dislocation recurrence rate in each group of patients
Measured: 1 year
intraoperative and postoperative complications
To ascertain intraoperative (loosening, protrusion, and breaking of material) and postoperative (infection, stiffness, and osteoarthritis) complications
Measured: 1 year
WOSI
To compare the clinical outcomes of the two patient groups using the Western Ontario Shoulder Instability Index (WOSI).
Measured: 1 year
ASES
To compare the clinical outcomes of the two patient groups using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
Measured: 1 year
Magnetic resonance imaging - LGHI
Labrum glenoid height index (LGHI) - ratio of the labral height to the glenoid height
Measured: 1 year
Magnetic resonance imaging - Labral Slope
Labral slope - angle between the line perpendicular to the deepest point of the glenoid to the labral glenoid apex
Measured: 1 year
Magnetic resonance imaging - Labral morphology
Labral morphology (PDW EXP sequence) with the Rondelli classification
Measured: 1 year
Magnetic resonance imaging - Anchor resorption
Anchor resorption (T1 sequence) according to Stein et al.
Measured: 1 year
Magnetic resonance imaging - Bone reaction
Bone reaction (T2 sequence) according to Hoffmann et al.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study start27 Feb 2017
- Primary completion23 Mar 2020
- Study completion16 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Lafraia Lobo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535585
- Sponsor's protocol ID
- 1134
- Status last verified
- Apr 2021
- First submitted
- 21 Aug 2015
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cutts S, Prempeh M, Drew S. Anterior shoulder dislocation. Ann R Coll Surg Engl. 2009 Jan;91(1):2-7. doi: 10.1308/003588409X359123.
PubMed 19126329Leroux T, Wasserstein D, Veillette C, Khoshbin A, Henry P, Chahal J, Austin P, Mahomed N, Ogilvie-Harris D. Epidemiology of primary anterior shoulder dislocation requiring closed reduction in Ontario, Canada. Am J Sports Med. 2014 Feb;42(2):442-50. doi: 10.1177/0363546513510391. Epub 2013 Nov 25.
PubMed 24275862Owens BD, Dawson L, Burks R, Cameron KL. Incidence of shoulder dislocation in the United States military: demographic considerations from a high-risk population. J Bone Joint Surg Am. 2009 Apr;91(4):791-6. doi: 10.2106/JBJS.H.00514.
PubMed 19339562Harris JD, Gupta AK, Mall NA, Abrams GD, McCormick FM, Cole BJ, Bach BR Jr, Romeo AA, Verma NN. Long-term outcomes after Bankart shoulder stabilization. Arthroscopy. 2013 May;29(5):920-33. doi: 10.1016/j.arthro.2012.11.010. Epub 2013 Feb 5.
PubMed 23395467Bollier MJ, Arciero R. Management of glenoid and humeral bone loss. Sports Med Arthrosc Rev. 2010 Sep;18(3):140-8. doi: 10.1097/JSA.0b013e3181e88ef9.
PubMed 20711045Kim SH, Ha KI, Cho YB, Ryu BD, Oh I. Arthroscopic anterior stabilization of the shoulder: two to six-year follow-up. J Bone Joint Surg Am. 2003 Aug;85(8):1511-8.
PubMed 12925631Carreira DS, Mazzocca AD, Oryhon J, Brown FM, Hayden JK, Romeo AA. A prospective outcome evaluation of arthroscopic Bankart repairs: minimum 2-year follow-up. Am J Sports Med. 2006 May;34(5):771-7. doi: 10.1177/0363546505283259.
PubMed 16627629Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.
PubMed 11027751Fabbriciani C, Milano G, Demontis A, Fadda S, Ziranu F, Mulas PD. Arthroscopic versus open treatment of Bankart lesion of the shoulder: a prospective randomized study. Arthroscopy. 2004 May;20(5):456-62. doi: 10.1016/j.arthro.2004.03.001.
PubMed 15122134Hayashida K, Yoneda M, Mizuno N, Fukushima S, Nakagawa S. Arthroscopic Bankart repair with knotless suture anchor for traumatic anterior shoulder instability: results of short-term follow-up. Arthroscopy. 2006 Jun;22(6):620-6. doi: 10.1016/j.arthro.2006.03.006.
PubMed 16762700Ng C, Bialocerkowski A, Hinman R. Effectiveness of arthroscopic versus open surgical stabilisation for the management of traumatic anterior glenohumeral instability. Int J Evid Based Healthc. 2007 Jun;5(2):182-207. doi: 10.1111/j.1479-6988.2007.00064.x.
PubMed 21631787Kim SH, Ha KI, Kim SH. Bankart repair in traumatic anterior shoulder instability: open versus arthroscopic technique. Arthroscopy. 2002 Sep;18(7):755-63. doi: 10.1053/jars.2002.31701.
PubMed 12209434Hobby J, Griffin D, Dunbar M, Boileau P. Is arthroscopic surgery for stabilisation of chronic shoulder instability as effective as open surgery? A systematic review and meta-analysis of 62 studies including 3044 arthroscopic operations. J Bone Joint Surg Br. 2007 Sep;89(9):1188-96. doi: 10.1302/0301-620X.89B9.18467.
PubMed 17905956Cooke SJ, Starks I, Kathuria V. The results of arthroscopic anterior stabilisation of the shoulder using the bioknotless anchor system. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jan 19;1(1):2. doi: 10.1186/1758-2555-1-2.
PubMed 19284697Barber FA, Herbert MA. Cyclic loading biomechanical analysis of the pullout strengths of rotator cuff and glenoid anchors: 2013 update. Arthroscopy. 2013 May;29(5):832-44. doi: 10.1016/j.arthro.2013.01.028. Epub 2013 Apr 2.
PubMed 23561482
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors
- ClinicalTrials.gov ID
- NCT02535585
- Acronym / sponsor ID
- 1134
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 16 Jan 2021 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs.
The researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
Detailed description
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. The overall incidence of first-time dislocations requiring closed reduction is 23.1 per 100,000 people/year, with a higher incidence in males and Caucasians. Individuals with a younger age at first dislocation show a higher rate of recurrence.
Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation, with similar outcomes to open repair. The technique is less aggressive because the tendon of the subscapularis does not need to be addressed, leading to shorter hospital stays, less scarring, earlier return to normal activities, and a greater postoperative range of motion.
In this technique, the glenoid labrum-ligament complex (GLLC) is repaired using bone anchors that can be metallic, absorbable, or flexible. Biomechanical studies have shown that these three types of anchors are similar in terms of cyclic loading resistance and bone fixation. Absorbable anchors are most frequently used because metallic anchors can cause postoperative imaging interference in MRI study, can migrate and became loose or break, which can damage the articular cartilage. Flexible anchors when submitted to cyclic stress can produce cystic cavities in bone tissue attachment 21, and probably can lead to a failure of glenoid labrum-ligament complex suture.
The most commonly used technique is the attachment of GLLC with knotted anchors. Studies have shown to perform an arthroscopic knot is challenging and can be technically difficult. The knot volume can produce friction during the shoulder movement, leading joint discomfort and cartilage damage. The quality of the soft tissue healing depend on the knot quality too. The dislocation recurrence rate with this technique ranges from 4% to 19%.
In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Although this new technique had solved the difficulty of tying knots, the results regarding the GLLC suture shown more gap formation between this complex and the glenoid bone, delayed anchor loosening and postoperative arthropathy. The recurrence rate is high associated with perianchor radiolucency.The recurrence rate with this technique is as high as 23.8%.
Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs.
Our researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knotted anchors | Active comparator | Device: knotted anchors (SutureTak biocomposite 3.0 mm)Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm). |
| knotless anchors | Active comparator | Device: knotless anchors (PushLock biocomposite 2.9 mm knotless)Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Skeletal maturity;
- Anterior glenohumeral instability;
- Previous labral lesion without bone defects or with defects that affect no more than 20% of the anteroposterior diameter of the glenoid, as shown by MRI;
- Instability severity index score (ISIS) < 4;
- Non-Inclusion Criteria
Key exclusion criteria (4 listed)
- Irreparable injury to the anterior capsule or injury to the humeral insertion of the inferior glenohumeral ligament;
- Glenoid bone defect greater than 20% of the anteroposterior diameter measured by arthroscopy;
- Rotator cuff tear found on arthroscopy;
- Abandonment of the rehabilitation program and follow-up before the first evaluation of outcomes
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 |
|---|---|---|
| knotted anchors (SutureTak biocomposite 3.0 mm)Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm). | Device | knotted anchors |
| knotless anchors (PushLock biocomposite 2.9 mm knotless)Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless) | Device | knotless anchors |
Primary outcome
Rowe scale
Time frame: 1 year
To compare, using the Rowe scale, clinical outcomes, at one year after surgery, of patients undergoing labral lesion suture using knotted anchors with those treated with knotless anchors.
9 secondary outcomes
dislocation recurrence rate
Time frame: 1 year
intraoperative and postoperative complications
Time frame: 1 year
WOSI
Time frame: 1 year
ASES
Time frame: 1 year
Magnetic resonance imaging - LGHI
Time frame: 1 year
Magnetic resonance imaging - Labral Slope
Time frame: 1 year
Magnetic resonance imaging - Labral morphology
Time frame: 1 year
Magnetic resonance imaging - Anchor resorption
Time frame: 1 year
Magnetic resonance imaging - Bone reaction
Time frame: 1 year
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 6 Apr 2021.
- Background: PubMed 19126329Cutts S, Prempeh M, Drew S. Anterior shoulder dislocation. Ann R Coll Surg Engl. 2009 Jan;91(1):2-7. doi: 10.1308/003588409X359123.
- Background: PubMed 24275862Leroux T, Wasserstein D, Veillette C, Khoshbin A, Henry P, Chahal J, Austin P, Mahomed N, Ogilvie-Harris D. Epidemiology of primary anterior shoulder dislocation requiring closed reduction in Ontario, Canada. Am J Sports Med. 2014 Feb;42(2):442-50. doi: 10.1177/0363546513510391. Epub 2013 Nov 25.
- Background: PubMed 19339562Owens BD, Dawson L, Burks R, Cameron KL. Incidence of shoulder dislocation in the United States military: demographic considerations from a high-risk population. J Bone Joint Surg Am. 2009 Apr;91(4):791-6. doi: 10.2106/JBJS.H.00514.
- Background: PubMed 23395467Harris JD, Gupta AK, Mall NA, Abrams GD, McCormick FM, Cole BJ, Bach BR Jr, Romeo AA, Verma NN. Long-term outcomes after Bankart shoulder stabilization. Arthroscopy. 2013 May;29(5):920-33. doi: 10.1016/j.arthro.2012.11.010. Epub 2013 Feb 5.
- Background: PubMed 20711045Bollier MJ, Arciero R. Management of glenoid and humeral bone loss. Sports Med Arthrosc Rev. 2010 Sep;18(3):140-8. doi: 10.1097/JSA.0b013e3181e88ef9.
- Background: PubMed 12925631Kim SH, Ha KI, Cho YB, Ryu BD, Oh I. Arthroscopic anterior stabilization of the shoulder: two to six-year follow-up. J Bone Joint Surg Am. 2003 Aug;85(8):1511-8.
- Background: PubMed 16627629Carreira DS, Mazzocca AD, Oryhon J, Brown FM, Hayden JK, Romeo AA. A prospective outcome evaluation of arthroscopic Bankart repairs: minimum 2-year follow-up. Am J Sports Med. 2006 May;34(5):771-7. doi: 10.1177/0363546505283259.
- Background: PubMed 11027751Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.
- Background: PubMed 15122134Fabbriciani C, Milano G, Demontis A, Fadda S, Ziranu F, Mulas PD. Arthroscopic versus open treatment of Bankart lesion of the shoulder: a prospective randomized study. Arthroscopy. 2004 May;20(5):456-62. doi: 10.1016/j.arthro.2004.03.001.
- Background: PubMed 16762700Hayashida K, Yoneda M, Mizuno N, Fukushima S, Nakagawa S. Arthroscopic Bankart repair with knotless suture anchor for traumatic anterior shoulder instability: results of short-term follow-up. Arthroscopy. 2006 Jun;22(6):620-6. doi: 10.1016/j.arthro.2006.03.006.
- Background: PubMed 21631787Ng C, Bialocerkowski A, Hinman R. Effectiveness of arthroscopic versus open surgical stabilisation for the management of traumatic anterior glenohumeral instability. Int J Evid Based Healthc. 2007 Jun;5(2):182-207. doi: 10.1111/j.1479-6988.2007.00064.x.
- Background: PubMed 12209434Kim SH, Ha KI, Kim SH. Bankart repair in traumatic anterior shoulder instability: open versus arthroscopic technique. Arthroscopy. 2002 Sep;18(7):755-63. doi: 10.1053/jars.2002.31701.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knotted anchors (SutureTak biocomposite 3.0 mm) and knotless anchors (PushLock biocomposite 2.9 mm knotless) in people with Shoulder Dislocation, run by University of Sao Paulo at 1 site in Brazil.
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 10 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: finished, as of the sponsor's last update on 6 Apr 2021. 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 Brazil. 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?
Rowe scale (time frame: 1 year). 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 NCT02535585, which also lists 54 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 6 Apr 2021.