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New treatment option for Rotator Cuff Injury
Official title Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
ClinicalTrials.gov ID: NCT06774820
What this study is testing
- What it's testing
- The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or...
- Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires.
You likely can't join if
- Tear type: partial thickness rotator cuff tears are excluded.
- Tear severity: individuals with massive or irreparable rotator cuff tears are excluded.
- Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in...
- Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or...
- Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion.
- Popeye sign: preoperative presence of the Popeye sign will result in exclusion.
See the full eligibility criteria
- Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI.
- Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires.
- Tear type: partial thickness rotator cuff tears are excluded.
- Tear severity: individuals with massive or irreparable rotator cuff tears are excluded.
- Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion.
- Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder)...
- Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion.
- Popeye sign: preoperative presence of the Popeye sign will result in exclusion.
- Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion.
- Pregnant, parturient or breast-feeding patients.
- Persons under legal protection (curatorship, guardianship, safeguard of justice).
- Persons deprived of their liberty by judicial or administrative measure
- Persons under psychiatric care
- Persons not affiliated to a social security scheme
The study team makes the final eligibility decision.
Where it's taking place
- Annecy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Annecy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.