Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

NCT07005063 | Recruiting DMC

• 2 other identifiers: ZM072024SNCTP000006378
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rotator Cuff Tear; Rotator Cuff Injury; Rotator Cuff Rupture

Keywords

Rotator cuff tear; Rotator cuff repair; Augmentation; Reinforcement; Mechanical augmentation

Outcome Measures

Primary Outcomes (6)

• 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.

  Surgery to 12-month follow-up

• 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.

  Surgery to 12-month follow-up

• 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.

  Surgery to 12-month follow-up

• 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.

  Surgery to 12-month follow-up

• 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.

  Surgery to 12-month follow-up

• 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.

  Surgery to 12-month follow-up

Secondary Outcomes (10)

• Retear Rate

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

• Constant-Murley Score

  Baseline and 12-month follow-up

• Visual Analog Scale for Pain (VAS)

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

• Subjective Shoulder Value (SSV) Score

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

• EQ-5D-5L survey

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

Study Arms (1)

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.

Device: FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)

Interventions

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

Augmentation of Rotator Cuff Repair using the FiberLocker System

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• Informed Consent signed by the subject
• Pre-operative MRI performed

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ZuriMED Technologies AG: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 17, 2025

Record last verified: 2025-05

Locations

CH (1)