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New treatment option for Rotator Cuff Tear
Official title Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
ClinicalTrials.gov ID: NCT06766630
What this study is testing
- What it's testing
- Rotator cuff tears result in shoulder joint pain and movement disorders, affecting patients' daily lives. The incidence rate rises with age and can be as high as 54% among people over 60 years old.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- Preoperative:
- Age range of 50-75 years old (inclusive), gender not limited;
- Patients who require surgery due to rotator cuff tears detected by clinical and MRI examination;
- Evaluated as type IV and above according to Sugaya classification criteria;
- Patients with persistent or recurrent pain in the shoulder for more than 3 months;
You likely can't join if
- 1\. Pregnant and lactating women; 2.Individuals with contraindications for surgery or anesthesia, as well as those who are allergic to known...
See the full eligibility criteria
- Preoperative:
- Age range of 50-75 years old (inclusive), gender not limited;
- Patients who require surgery due to rotator cuff tears detected by clinical and MRI examination;
- Evaluated as type IV and above according to Sugaya classification criteria;
- Patients with persistent or recurrent pain in the shoulder for more than 3 months;
- Full layer tendon tear of 1-5cm or full layer or complete tear of supraspinatus and/or infraspinatus tendon;
- History of non-surgical treatment failure;
- Understand the purpose of the trial, cooperate with surgical treatment and follow-up, voluntarily participate in the trial and sign an informed consent form; Intraoperative:
- Confirmed as a full-thickness tear of 1-5cm on the rotator cuff;
- Tendons can cover more than 50% of the humeral greater tuberosity of the shoulder joint.
- 1\. Pregnant and lactating women; 2.Individuals with contraindications for surgery or anesthesia, as well as those who are allergic to known ingredients of implanted products; 3. Unable to undergo MRI examination due to...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
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, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. 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.