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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. Identifier: NCT03199391
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : August 10, 2020
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant. Both performance and safety data will be collected.

Condition or disease Intervention/treatment
Rotator Cuff Tear Device: BioWick SureLock Implant

Detailed Description:

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.

Secondary Objective

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.

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Survivorship [ Time Frame: 12 months post-operative ]
    The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative.

Secondary Outcome Measures :
  1. Survivorship [ Time Frame: 3 and 6 months post-operative ]
    Implant survivorship at visit intervals other than 12 months

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from patients requiring rotator cuff repair surgery.

Inclusion Criteria:

  1. Clinical diagnosis of rotator cuff tear which is greater than or equal to 1.5 cm and less than or equal to 4.0 cm full thickness of either the supraspinatus or infraspinatus determined by MRI which has not been previously repaired;
  2. Goutallier Stage 2 or less;
  3. Patte Stage II (mid humeral head retraction);
  4. Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;
  5. Subject is skeletally mature at the surgical site;
  6. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

  1. Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);
  2. Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;
  3. If female, subject is pregnant;
  4. Presence of local or systemic infection;
  5. Suprascapular nerve compression requiring release or documented by EMG-NCV;
  6. Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance;
  7. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation;
  8. Insufficient blood supply or previous infection which may hinder the healing process;
  9. Subject conditions including: insufficient quantity or quality of bone or soft tissue, or immature bone where the device may impact or disrupt the growth plate;
  10. Subject is a prisoner or member of another vulnerable population;
  11. Cortisone injection within 6 weeks prior to surgical treatment;
  12. Use of immune suppressants or chemotherapeutic medications within the last 12 months;
  13. Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03199391

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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
Sponsors and Collaborators
Zimmer Biomet
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Study Director: Erin Osborn
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Responsible Party: Zimmer Biomet Identifier: NCT03199391    
Other Study ID Numbers: CAY-001
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries