Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorZuriMED Technologies AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
DeviceThe 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Augmentation of Rotator Cuff Repair using the FiberLocker SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Surgery to 12-month follow-up2
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.
Time frame
Surgery to 12-month follow-up3
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.
Time frame
Surgery to 12-month follow-up4
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.
Time frame
Surgery to 12-month follow-upSecondary outcomes
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).
Time frame
6-week, 4.5-month and 12-month follow-up2
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.
Time frame
Baseline and 12-month follow-up3
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.
Time frame
Baseline, 2-week, 4.5-month and 12-month follow-up4
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.
Time frame
Baseline, 4.5-month and 12-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov