Rotator Cuff TearNCT03199391
BioWick SureLock Clinical Outcomes Study
A study testing BioWick SureLock Implant in people with Rotator Cuff Tear, run by Zimmer Biomet at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- BioWick SureLock Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Apr 2017to 5 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Goutallier Stage 2 or less;
- Patte Stage II (mid humeral head retraction);
- Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;
- Subject is skeletally mature at the surgical site;
- Subject is able to read and understand the ICF and has voluntarily provided written informed consent.
Who cannot join
- Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);
- Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;
- If female, subject is pregnant;
- Presence of local or systemic infection;
- Suprascapular nerve compression requiring release or documented by EMG-NCV;
- Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance;
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- Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation;
- Insufficient blood supply or previous infection which may hinder the healing process;
- 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;
- Subject is a prisoner or member of another vulnerable population;
- Cortisone injection within 6 weeks prior to surgical treatment;
- Use of immune suppressants or chemotherapeutic medications within the last 12 months;
- Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Orthopaedic Medical Group of Tampa Bay PA
Brandon, Florida, 33511
University of Virginia
Charlottesville, Virginia, 22903
Norton Orthopaedics and Sports Medicine
Louisville, Kentucky, 40241
The Orthopaedic Clinic Association
Phoenix, Arizona, 85016
Eisenhower Medical Center
Rancho Mirage, California, 92270
University of Utah
Salt Lake City, Utah, 84108
Foundation for Orthopaedic Research and Eduation
Temple Terrace, Florida, 33637
About this study
Official title: Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- BioWick SureLock Implant
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioWick SureLock ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BioWick SureLock Implant | Experimental | All subjects are part of a single arm. All subjects received the BioWick SureLock implant. Receives: Device: BioWick SureLock Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Not Requiring Removal or Reoperation of the Implant
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Measured: 12 months
Secondary outcomes (7)
Number of Participants Not Requiring Removal or Reoperation of the Implant
Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Measured: 3 months, 6 months
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Measured: Preoperative, 3 months, 6 months, 1 year
Visual Analogue Scale (VAS) Pain Score
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. Possible scores range from 0 (no pain) to 10 (very much pain).
Measured: Preoperative, 3 months, 6 months, 1 year
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Measured: Preoperative, 3 months, 6 months, 1 year
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Measured: Preoperative, 3 months, 6 months, 1 year
Range of Motion (ROM) - Active Forward Elevation
Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees.
Measured: Preoperative, 3 months, 6 months, 1 year
Device Safety
Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as "Definitely" or "Possibly" related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start26 Apr 2017
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Boylan, Study director, ryan.boylan@zimmerbiomet.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199391
- Sponsor's protocol ID
- CAY-001
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2017
- Last updated
- 7 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
- ClinicalTrials.gov ID
- NCT03199391
- Acronym / sponsor ID
- CAY-001
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 25 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioWick SureLock Implant | Experimental | Device: BioWick SureLock ImplantAll subjects are part of a single arm. All subjects received the BioWick SureLock implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Goutallier Stage 2 or less;
- Patte Stage II (mid humeral head retraction);
- Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;
- Subject is skeletally mature at the surgical site;
Key exclusion criteria (13 listed)
- Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);
- Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;
- If female, subject is pregnant;
- Presence of local or systemic infection;
- Suprascapular nerve compression requiring release or documented by EMG-NCV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioWick SureLock ImplantThe 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. | Device | BioWick SureLock Implant |
Primary outcome
Number of Participants Not Requiring Removal or Reoperation of the Implant
Time frame: 12 months
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
7 secondary outcomes
Number of Participants Not Requiring Removal or Reoperation of the Implant
Time frame: 3 months, 6 months
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
Time frame: Preoperative, 3 months, 6 months, 1 year
Visual Analogue Scale (VAS) Pain Score
Time frame: Preoperative, 3 months, 6 months, 1 year
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
Time frame: Preoperative, 3 months, 6 months, 1 year
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
Time frame: Preoperative, 3 months, 6 months, 1 year
Range of Motion (ROM) - Active Forward Elevation
Time frame: Preoperative, 3 months, 6 months, 1 year
Device Safety
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Boylan study director
ryan.boylan@zimmerbiomet.com
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioWick SureLock Implant in people with Rotator Cuff Tear, run by Zimmer Biomet at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Not Requiring Removal or Reoperation of the Implant (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.