Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLockerĀ® System (encompassing the SpeedPatchĀ® PET and the FiberLockerĀ® 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmentation of Rotator Cuff Repair using the FiberLockerĀ® System | Experimental | All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLockerĀ® System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiberLockerĀ® System (encompassing FiberLockerĀ® Instrument & SpeedPatchĀ® PET) | Device | The FiberLockerĀ® System is a mechanical augmentation system that includes an implant (SpeedPatchĀ® PET) and an instrument (FiberLockerĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-operatively & minimum 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
Not provided
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From the surgical intervention to 24 months postoperatively |
| MedStar Health Research Institute | Recruiting | Columbia | Maryland | 21044 | United States |
|
| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Southern Oregon Orthopedics Research Foundation | Recruiting | Medford | Oregon | 97504 | United States |
|