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Rotator Cuff TearFIBERLOCKNCT07005063

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

A study testing FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN) in people with Rotator Cuff Tear and Rotator Cuff Injury, run by ZuriMED Technologies AG at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years
What is being tested?
FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
3 Jul 2025to 30 Jun 2029
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Vulnerable subjects (as defined in ISO 14155)
  • Subjects 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
Show all 29Show fewer
  • 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)
  • Subjects 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting

  • Balgrist University Hospital

    Zurich, Canton of Zurich, 8008

    Karl Wieser, Prof. Dr. med., +41 44 386 30 12, schulter@balgrist.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study

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. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

Being tested
FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
Keywords
Rotator cuff tear, Rotator cuff repair, Augmentation, Reinforcement, Mechanical augmentation
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 SpeedPatch® PET and FiberLocker Instrument® SN)Device

    The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) 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 groups in NCT07005063
Study groupRoleWhat they receive
Augmentation of Rotator Cuff Repair using the FiberLocker SystemExperimentalAll enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker System.
Receives: Device: FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Adverse Events (AEs)

    All operative and postoperative AEs will be recorded. Safety outcomes will be determined by evaluating the type, frequency, seriousness, and relationship to device or procedure of AEs for all subjects.

    Measured: Surgery to 12-month follow-up

  2. Total Number of Serious Adverse Events (SAEs)

    All operative and postoperative SAEs will be recorded. Safety outcomes will be determined by evaluating the type, frequency, and relationship to device or procedure of SAEs for all subjects.

    Measured: Surgery to 12-month follow-up

  3. Number of AE related to Device

    The operative and postoperative AEs that are related to the device will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.

    Measured: Surgery to 12-month follow-up

  4. Number of SAE related to Device

    The operative and postoperative SAEs that are related to the device will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.

    Measured: Surgery to 12-month follow-up

  5. Number of AE related to Procedure

    The operative and postoperative AEs that are related to the procedure will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.

    Measured: Surgery to 12-month follow-up

  6. Number of SAE related to Procedure

    The operative and postoperative SAEs that are related to the procedure will be reported. Safety outcomes will be determined by evaluating the type and frequency for all subjects.

    Measured: Surgery to 12-month follow-up

Secondary outcomes (10)

  1. Retear Rate

    Retears are defined as repairs showing structural defect of the tendon bone-interface on MRI according to type IV or V of the Sugaya classification. Cuff integrity according to the Sugaya classification is defined as follows: type I (repaired cuff of sufficientthickness, homogeneously low signal intensity), type II (sufficient thickness, partial high-signal intensity area), type III (insufficient thickness without discontinuity), type IV (minor discontinuity in 1 section, suggestive of a small tear), type V (major discontinuity in each image, suggestive of a medium-to-large tear).

    Measured: 6-week, 4.5-month and 12-month follow-up

  2. Constant-Murley Score

    The Constant score will be calculated in a 100-point scale and compared with baseline. It will be measured with a patient-reported questionnaire \& medical professional assessment at baseline and 12-month follow-up visit. A higher score indicates better function.

    Measured: Baseline and 12-month follow-up

  3. Visual Analog Scale for Pain (VAS)

    The VAS score will be calculated in a 0 to 10 scale and compared with baseline. Thereby, a higher score indicates greater pain intensity. VAS for average pain score over the last 24 hours will be assessed with a questionnaire.

    Measured: Baseline, 2-week, 4.5-month and 12-month follow-up

  4. Subjective Shoulder Value (SSV) Score

    The SSV 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: Baseline, 4.5-month and 12-month follow-up

  5. EQ-5D-5L survey

    The EQ-5D-5L survey is a patient-reported outcome and consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ VAS is the patient's self-rated health on a vertical visual analogue scale (0-100), whereas a higher score represents better health.

    Measured: Baseline, 4.5-month and 12-month follow-up

  6. American Shoulder and Elbow Society (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: Baseline, 4.5-month and 12-month follow-up

  7. 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: repaired cuff of sufficient thickness, homogeneously low signal intensity
    • Type II: sufficient thickness, partial high-signal intensity area
    • Type III: insufficient thickness without discontinuity
    • Type IV: minor discontinuity in 1 section, suggestive of a small tear
    • Type V: major discontinuity in each image, suggestive of a medium-to-large tear

    Measured: 6-week, 4.5-month and 12-month follow-up

  8. Goutallier Classification

    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 rotator cuff of each subject will be classified. Thereby, a higher classification means more fatty infiltration.

    Measured: Baseline, 6-week, 4.5-month and 12-month follow-up

  9. Tendon Thickness

    Tendon thickness of the affected rotator cuff tendon will be measured in a MRI images (in mm).

    Measured: Baseline, 6-week, 4.5-month and 12-month follow-up

  10. Fat Fraction of Muscle

    Fat fraction of muscle quantified in Dixon sequence will be evaluated on the MRI images. Accordingly, the range can be from 0% to 100%. A higher percentage indicates more fatty infiltration.

    Measured: Baseline, 6-week, 4.5-month and 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start3 Jul 2025
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005063
Sponsor's protocol ID
ZM072024
Other IDs
SNCTP000006378
Acronym
FIBERLOCK
Status last verified
Aug 2026
First submitted
26 May 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN) in people with Rotator Cuff Tear and Rotator Cuff Injury, run by ZuriMED Technologies AG at 1 site in Switzerland.

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 7 inclusion and 29 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 1 Sep 2026. 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 Switzerland. 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?

Total Number of Adverse Events (AEs) (time frame: Surgery to 12-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07005063.

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 1 Sep 2026.

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