BioWick SureLock Clinical Outcomes Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03199391|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : August 10, 2020
|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, and 12 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 12 months.
Primary Objective The primary objective of this study is to assess survivorship (lack of reoperation/device removal) 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 ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, and 12 months postoperative.
- To document the postmarket effectiveness of the BioWick SureLock implant using range of motion (ROM) measurements with the corresponding assessments made at 3 months and 6 months postoperative.
- To document device safety via device-related adverse events reported over the course of the study.
|Study Type :||Observational|
|Actual Enrollment :||71 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, 2021|
|Estimated Study Completion Date :||September 30, 2021|
- 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.
- Survivorship [ Time Frame: 12 months post-operative ]The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative.
- Survivorship [ Time Frame: 3 and 6 months post-operative ]Implant survivorship at visit intervals other than 12 months
- VR-12 Score [ Time Frame: 3, 6, and 12 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, and 12 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, and 12 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, and 12 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:||Erin Osbornfirstname.lastname@example.org|