BioWick SureLock Clinical Outcomes Study
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|ClinicalTrials.gov Identifier: NCT03199391|
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2017
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment|
|Rotator Cuff Tear||Device: BioWick SureLock Implant|
Study Title Efficacy of the BioWick™ SureLock™ Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
Sponsor Cayenne Medical, Inc., a Zimmer Biomet company
Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both preoperative assessments and follow-up assessments at 3 months, 6 months, 12 months, and 24 months.
Clinical Phase Postmarket
Number of Sites Up to ten sites in the U.S.
Study Duration per Subject Subjects will be enrolled in the study for up to 24 months.
Primary Objective The primary objective of this study is to assess the structural failure rate with the use of the BioWick™ SureLock™ implant.
The secondary objectives of this study are :
- To document the postmarket effectiveness of the BioWick™ SureLock™ implant using range of motion measurements, ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, 12 months, and 24 months.
- To document device safety via device-related adverse events reported over the course of the study.
|Study Type :||Observational|
|Estimated Enrollment :||83 participants|
|Official Title:||Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||May 31, 2023|
- Device: BioWick SureLock Implant
The BioWick™ SureLock™ implant is a device for shoulder and extremity surgery, constructed of Ultra High Molecular Weight Polyethylene Suture. BioWick™ SureLock™ is uniquely designed to minimize these risks by avoiding manual tensioning with an inserter mechanism that ensures that the implant is consistently deployed below the cortex.
- Structural Failure Rate [ Time Frame: 6 months post-operative ]The primary endpoint of this study is the structural failure rate of the rotator cuff repair, determined by MRI, at 6 months following placement of the BioWick™ SureLock™ implant.
- Revision Rate [ Time Frame: 12 and 24 months post-operative ]Rate of the number of revisions of study devices
- Structural Failure Rate [ Time Frame: 3 months post-operative ]Rate of failed structural integrity of rotator cuff
- VR-12 Score [ Time Frame: 3, 6, 12, and 24 months post-operative ]brief, generic, multi-use, self-administered health surveys comprised of 36 and 12 items respectively. The instruments are primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations.
- ASES rating scale [ Time Frame: 3, 6, 12, and 24 months post-operative ]The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living.
- VAS Pain Scores [ Time Frame: 3, 6, 12, and 24 months post-operative ]A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
- Range of Motion [ Time Frame: 3, 6, 12, and 24 months post-operative ]Range of motion: The full movement potential of a joint, usually its range of flexion and extension.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199391
|United States, Arizona|
|The Orthopaedic Clinic Association|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|Eisenhower Medical Center|
|Rancho Mirage, California, United States, 92270|
|United States, Florida|
|Orthopaedic Medical Group of Tampa Bay PA|
|Brandon, Florida, United States, 33511|
|Foundation for Orthopaedic Research and Eduation|
|Temple Terrace, Florida, United States, 33637|
|United States, Kentucky|
|Norton Orthopaedics and Sports Medicine|
|Louisville, Kentucky, United States, 40241|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Study Director:||Bill Bourdeauemail@example.com|