Rotator Cuff TearNCT06918041
FiberLocker® System Augmentation of Rotator Cuff Repairs
A study testing FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET) in people with Rotator Cuff Tear and Rotator Cuff Tears, run by ZuriMED Technologies Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder
- What is being tested?
- FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Aug 2025to 1 Apr 2028
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Subject is between the ages of 30 and 70 years.
- Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
- Tear size ≥ 2 cm
- Primary rotator cuff repair
- Subject preoperative MRI obtained within 1 year prior to surgery
Who cannot join
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to the use of the FiberLocker® System
- History or known allergy or intolerance to polyester
- Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- Hamada grade III and above
- Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
Show all 20Show fewer
- Recurrent shoulder instability
- Corticosteroid injection in the operative shoulder within three months before surgery
- Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Subjects with current acute infection in the area surrounding the surgical site
- Revision rotator cuff repair
- Pregnant or planning to become pregnant during the study period
- Subject is breastfeeding during the study period
- Subject has conditions or circumstances that would interfere with study requirements
- The subject's condition represents a worker's compensation case
- Intraoperative Exclusion Criteria:
- Partial rotator cuff repairs
- Lafosse grade 3 or higher subscapularis tears
- Limited space for implant delivery
- FiberLocker® System cannot be used as indicated
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Ryan Lee, 312-432-2337, nicholson.research@rushortho.com
Nikhil N Verma, MD
- Recruiting
MedStar Health Research Institute
Columbia, Maryland, 21044
Crisanto Macaraeg, 410-261-8218, crisanto.l.macaraeg@medstar.net
Anand Murthi, MD
- Recruiting
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, 97504
Lindsey Chin, 541-608-2572, lindseyc@sooresearch.net
Patrick Denard, MD
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27157
Rebecca Keith, 336-716-5868, Becky.Keith@Advocatehealth.org
Brian R Waterman, MD
About this study
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument).
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.
The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.
- Being tested
- FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
- Keywords
- Rotator Cuff Tears, Rotator Cuff Repair, Augmentation, Reinforcement, Mechanical Augmentation, Rotator Cuff Degeneration
- 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.
FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)Device
The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.
| Study group | Role | What they receive |
|---|---|---|
| Augmentation of Rotator Cuff Repair using the FiberLocker® System | Experimental | All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System. Receives: Device: FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Evaluation
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.
A standard shoulder MRI protocol utilizing a minimum of a 1.5 Tesla magnet will be utilized. The cuff integrity will be classified using the 5 categories described by Sugaya et al. Thereby, type IV and V are considered as retear and type I, II, and III as healed. The healing rate will be estimated and reported descriptively, and a 95% confidence interval will be reported assuming a binomial distribution (unless otherwise noted).
Measured: Pre-operatively & minimum 6 months post-operatively
Secondary outcomes (11)
Sugaya Classification
The Sugaya Classification based on MRI images is used to evaluate the integrity of a repaired rotator cuff and to assess healing outcomes after a repair. The classification uses a categorial scoring system with grades from Type I to Type V. - Type I: Normal thickness and low signal intensity in all sections
- Type II: Normal thickness and high signal intensity
- Type III: Insufficient thickness without discontinuity, representing a partial-thickness tear
- Type IV: Minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images
- Type V: Major discontinuity (>2 slices) on both oblique coronal and sagittal images
Measured: Minimum 6 months post-operatively
Goutallier Stage
The Goutallier Classification is evaluated using MRI images to assess fatty infiltration and muscle degeneration in the rotator cuff. It has a categorial grading system from stage 0 to 4.
Based on MRI images, the investigator classifies the rotator cuff of each subject. Thereby, a higher classification means more fatty infiltration.
Measured: Pre-operatively & minimum 6 months post-operatively
Tendon Quality
The tendon quality of each subject is graded based on MRI images using a categorial scoring system.
The following classification can be used: Normal, Intact with edema/regularity, Partial tearing and/or abnormal tissue, Complete Tear/Abnormal.
Measured: Pre-operatively & minimum 6 months post-operatively
American Shoulder and Elbow Surgeons (ASES) Score
The ASES score is a patient-reported outcome measure survey which is completed by all subjects. It is used to assess shoulder function and pain. Based on the answers, a final score between 0 and 100 can be achieved. Thereby, higher scores indicate better shoulder function and less pain.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE) Score
The SANE score is a patient-reported outcome measure used to assess a patient's perception of their shoulder function. It consists of a single question and each subject has to rate their shoulder function on a scale from 0% to 100%. Thereby, higher percentages indicates better shoulder function.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Visual Analog Scale for pain (VAS Score)
The VAS Score is a patient-reported outcome measure used to assess pain intensity. All patients rate their pain on a horizontal line ranging from 0 to 10. Thereby, a higher score indicates greater pain intensity.
Measured: Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months
Veterans RAND 12-Item Health Survey (VR-12)
The VR-12 is a patient-reported outcome measure assessing physical and mental health of the subjects. Based on their answers, the subjects can reach a score between 0 and 100, with a higher score indicating better health.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Range of Motion (ROM) Assessment
The subject's active ROM (based on the objective ASES score) is assessed using a goniometer. During an outpatient visit at the investigators facility, forward flexion, external rotation, abducted external rotation, abducted internal rotation and internal rotation will be evaluated. The unit of measure is degrees.
If subjects are unable to return for an in person visit, an optional self-assessment of these range of motion form will be provided for electronic completion.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Strength Assessment
The strength of each subject will be evaluated (based on objective ASES) using a manual muscle testing device or other dynamometers. Thereby, external rotation strength, subscapularis strength-belly press and the constant score strength will be evaulated. The unit of measure will be kilograms or pounds.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Constant-Murley Score
The Constant-Murley Score will be assessed optionally. The score requires an outpatient visit at the investigator's facility and covers questions and functional assessments to assess pain, activity levels, range of motion and strength. The range of motion is assessed using a goniometer in degrees and the strength using a manual muscle testing device (or other dynamometers) in kilogram. The subjects can reach points between 0 and 100, whereby a higher score indicates better function.
Measured: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional)
(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies
(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies will be reported by the research staff as soon as they occur.
Measured: From the surgical intervention to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start5 Aug 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZuriMED Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918041
- Sponsor's protocol ID
- ZM102024
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FiberLocker® System Augmentation of Rotator Cuff Repairs
- ClinicalTrials.gov ID
- NCT06918041
- Acronym / sponsor ID
- ZM102024
- Keywords
- Rotator Cuff Tears, Rotator Cuff Repair, Augmentation, Reinforcement, Mechanical Augmentation, Rotator Cuff Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ZuriMED Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Apr 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.
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument).
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.
The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmentation of Rotator Cuff Repair using the FiberLocker® System | Experimental | Device: FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The Subject is between the ages of 30 and 70 years.
- Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
- Tear size ≥ 2 cm
- Primary rotator cuff repair
- Subject preoperative MRI obtained within 1 year prior to surgery
Key exclusion criteria (20 listed)
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to the use of the FiberLocker® System
- History or known allergy or intolerance to polyester
- Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- Hamada grade III and above
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 |
|---|---|---|
| FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue. | Device | Augmentation of Rotator Cuff Repair using the FiberLocker® System |
Primary outcome
Healing Evaluation
Time frame: Pre-operatively & minimum 6 months post-operatively
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. A standard shoulder MRI protocol utilizing a minimum of a 1.5 Tesla magnet will be utilized. The cuff integrity will be classified using the 5 categories described by Sugaya et al. Thereby, type IV and V are considered as retear and type I, II, and III as healed. The healing rate will be estimated and reported descriptively, and a 95% confidence interval will be reported assuming a binomial distribution (unless otherwise noted).
11 secondary outcomes
Sugaya Classification
Time frame: Minimum 6 months post-operatively
Goutallier Stage
Time frame: Pre-operatively & minimum 6 months post-operatively
Tendon Quality
Time frame: Pre-operatively & minimum 6 months post-operatively
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE) Score
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Visual Analog Scale for pain (VAS Score)
Time frame: Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months
Veterans RAND 12-Item Health Survey (VR-12)
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Range of Motion (ROM) Assessment
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Strength Assessment
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Constant-Murley Score
Time frame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional)
(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies
Time frame: From the surgical intervention to 24 months postoperatively
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 8 Jul 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET) in people with Rotator Cuff Tear and Rotator Cuff Tears, run by ZuriMED Technologies Inc. at 4 sites in United States.
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 5 inclusion and 20 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Evaluation (time frame: Pre-operatively & minimum 6 months post-operatively). 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 8 Jul 2026.