Rotator Cuff TearPhase 2/3NCT06766630
Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
A Phase 2/3 study testing Silk fibroin surgical mesh in people with Rotator Cuff Tear, run by Weiliang Shen, Ph.D., M.D. at 1 site in China.
Trial summary
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. Most rotator cuff tears are unable to heal spontaneously, and the tear area may gradually expand over time. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Silk fibroin surgical mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to 19 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 claustrophobia and other reasons; 4. Individuals with a history of rotator cuff repair on the affected side, or combined with other bone, joint, or muscle soft tissue injuries in the same limb; 5.Patients with subscapular muscle injury; 6.Those with any combination of diseases or symptoms that may affect the evaluation of efficacy, such as Hamada classification of grade 3 shoulder joint disease; 7.Those with residual rotator cuff tendon fatty infiltration ≥ grade 3 by Goutallier classification; 8.Individuals who have taken oral steroids or received steroid injections within 6 weeks prior to surgery; 9.Those who have participated in other interventional clinical trials within the past 3 months prior to the conduct of this trial; 10. Researchers believe that clinical trial participants who are not suitable for participation include but are not limited to those with uncontrolled blood sugar levels, heavy drinkers, smokers, and others who affect repair and healing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Weiliang Shen, 86 137 5710 1563, wlshen@zju.edu.cn
About this study
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. Most rotator cuff tears are unable to heal spontaneously, and the tear area may gradually expand over time. Currently, the main surgical treatment for rotator cuff tears is to use suture anchors to stitch the rotator cuff tendon tissue back to the original anatomical insertion point. Large rotator cuff tears are often accompanied by fat infiltration and tendon retraction. When forcefully sutured, the tension is relatively high, which may lead to non-healing and re-tearing of the rotator cuff. Research indicates that the re-tear rate after rotator cuff tear repair is 20% - 30%, and this probability can reach 40% - 50% for large rotator cuff tears. For these irreparable and large tears, rotator cuff repair typically requires patch augmentation techniques. Surgeries are based on restoring the force couple effect of the rotator cuff as much as possible and covering it with repair materials to achieve reinforcement. Silk fibroin surgical mesh is made of silk fibroin which has good biocompatibility and can be generally placed in the area of rotator cuff tears that cannot be repaired through conventional surgeries. By providing support to the injured rotator cuff tissue, it improves the repair effect. It can reestablish the integrity of the rotator cuff, reducing mechanical tension at the repair site and maintaining the stability of the glenohumeral joint. Besides, it can also promote tissue healing, and cell infiltration and growth, thereby facilitating the biological repair of the injured rotator cuff and reducing the occurrence of postoperative re-tears.
- Conditions
- Rotator Cuff Tear
- Being tested
- Silk fibroin surgical mesh
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk fibroin surgical meshDevice
This product is a mesh patch made of mulberry silk by warp knitting and degumming. The main component is fibroin protein
| Study group | Role | What they receive |
|---|---|---|
| using silk fibroin surgical mesh to enhance rotator cuff tear repair | Experimental | Not described Receives: Device: Silk fibroin surgical mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-tear rate at 12 months postoperatively
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (6)
Re-tear rate at 6 months postoperatively
Measured: From enrollment to 6 months after surgery
Constant-Murley Score postoperatively
Measured: From enrollment to the end of treatment at 12 months
Oxford Shoulder Score postoperatively
Measured: From enrollment to the end of treatment at 12 months
Degree of muscle atrophy
Measured: From enrollment to the end of treatment at 12 months
Fatty infiltration grading
Measured: From enrollment to the end of treatment at 12 months
Tendon thickness
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start19 Dec 2024
- Primary completion19 Dec 2025 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiliang Shen, Ph.D., M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weiliang Shen, Ph.D., M.D., Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766630
- Sponsor's protocol ID
- 20241282
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement
- ClinicalTrials.gov ID
- NCT06766630
- Acronym / sponsor ID
- 20241282
- Conditions
- Rotator Cuff Tear
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weiliang Shen, Ph.D., M.D.University, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
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. Most rotator cuff tears are unable to heal spontaneously, and the tear area may gradually expand over time. Currently, the main surgical treatment for rotator cuff tears is to use suture anchors to stitch the rotator cuff tendon tissue back to the original anatomical insertion point. Large rotator cuff tears are often accompanied by fat infiltration and tendon retraction. When forcefully sutured, the tension is relatively high, which may lead to non-healing and re-tearing of the rotator cuff. Research indicates that the re-tear rate after rotator cuff tear repair is 20% - 30%, and this probability can reach 40% - 50% for large rotator cuff tears. For these irreparable and large tears, rotator cuff repair typically requires patch augmentation techniques. Surgeries are based on restoring the force couple effect of the rotator cuff as much as possible and covering it with repair materials to achieve reinforcement. Silk fibroin surgical mesh is made of silk fibroin which has good biocompatibility and can be generally placed in the area of rotator cuff tears that cannot be repaired through conventional surgeries. By providing support to the injured rotator cuff tissue, it improves the repair effect. It can reestablish the integrity of the rotator cuff, reducing mechanical tension at the repair site and maintaining the stability of the glenohumeral joint. Besides, it can also promote tissue healing, and cell infiltration and growth, thereby facilitating the biological repair of the injured rotator cuff and reducing the occurrence of postoperative re-tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| using silk fibroin surgical mesh to enhance rotator cuff tear repair | Experimental | Device: Silk fibroin surgical mesh |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Preoperative:
Key exclusion criteria (1 listed)
- 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 claustrophobia and other reasons; 4. Individuals with a history of rotator cuff repair on the affected side, or combined with other bone, joint, or muscle soft tissue injuries in the same limb; 5.Patients with subscapular muscle injury; 6.Those with any combination of diseases or symptoms that may affect the evaluation of efficacy, such as Hamada classification of grade 3 shoulder joint disease; 7.Those with residual rotator cuff tendon fatty infiltration ≥ grade 3 by Goutallier classification; 8.Individuals who have taken oral steroids or received steroid injections within 6 weeks prior to surgery; 9.Those who have participated in other interventional clinical trials within the past 3 months prior to the conduct of this trial; 10. Researchers believe that clinical trial participants who are not suitable for participation include but are not limited to those with uncontrolled blood sugar levels, heavy drinkers, smokers, and others who affect repair and healing.
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 |
|---|---|---|
| Silk fibroin surgical meshThis product is a mesh patch made of mulberry silk by warp knitting and degumming. The main component is fibroin protein | Device | using silk fibroin surgical mesh to enhance rotator cuff tear repair |
Primary outcome
Re-tear rate at 12 months postoperatively
Time frame: From enrollment to the end of treatment at 12 months
6 secondary outcomes
Re-tear rate at 6 months postoperatively
Time frame: From enrollment to 6 months after surgery
Constant-Murley Score postoperatively
Time frame: From enrollment to the end of treatment at 12 months
Oxford Shoulder Score postoperatively
Time frame: From enrollment to the end of treatment at 12 months
Degree of muscle atrophy
Time frame: From enrollment to the end of treatment at 12 months
Fatty infiltration grading
Time frame: From enrollment to the end of treatment at 12 months
Tendon thickness
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Silk fibroin surgical mesh in people with Rotator Cuff Tear, run by Weiliang Shen, Ph.D., M.D. at 1 site in China.
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 11 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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 China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinchun Ye (86 17857158596, 21918382@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-tear rate at 12 months postoperatively (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025.