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New treatment option for Rotator Cuff Tear
Official title Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
ClinicalTrials.gov ID: NCT07005063
What this study is testing
- What it's testing
- The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65
You may be able to join if
- Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
- Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
- The rotator cuff tear is of traumatic origin.
- Subject is ≥ 40 years of age \& ≤ 65 years of age.
- Primary rotator cuff repair
You likely can't join if
- Vulnerable people (as defined in ISO 14155)
- people who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to...
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- Previous enrolment into the current investigation,
- Enrolment of the PI, his/her family members, employees and other dependent persons,
- Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological...
See the full eligibility criteria
- Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
- Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
- The rotator cuff tear is of traumatic origin.
- Subject is ≥ 40 years of age \& ≤ 65 years of age.
- Primary rotator cuff repair
- Informed Consent signed by the subject
- Pre-operative MRI performed
- Vulnerable people (as defined in ISO 14155)
- people who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- Previous enrolment into the current investigation,
- Enrolment of the PI, his/her family members, employees and other dependent persons,
- Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject
- Active smoker
- History of claustrophobia that would prevent an MRI of the index shoulder
- Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
- Pregnant or planning to become pregnant during the study period
- Breast feeding women
- Subject has conditions or circumstances that would interfere with study requirements.
- Contraindications and limitations of the MD as described in the IFUs.
- Partial rotator cuff tears
- History or known allergy or intolerance to polyester
- Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
- Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
- Limited space or exposure for implant delivery
- Structural or pathological condition of the bone or soft tissue that could impair healing.
- Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
- Fatty infiltration of the index shoulder rotator cuff muscle \> Goutallier Score 2
- Corticosteroid injection in the operative shoulder within 6 weeks of operation
- Subject shows frozen shoulder/adhesive capsulitis at day of surgery
- Cases of moderate to severe osteoarthritis
- Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)
- people with diabetes type I or II
- The subject currently has an acute infection in the area surrounding the surgical site
- Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.
- Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. 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.