- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552119
Safety of Treatment of Shoulder Repair (HEALICOIL_KNTL)
April 1, 2024 updated by: Smith & Nephew, Inc.
Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with rotator cuff tendon repair.
Approximately 160 subjects will be enrolled at up to 6 sites.
Safety monitoring will include documentation device- and surgery-related AEs.
Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.
Study Type
Observational
Enrollment (Estimated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edith Anunciacion
- Phone Number: 1-682-346-5317
- Email: edith.anunciacion@smith-nephew.com
Study Locations
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California
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Redwood City, California, United States, 94063
- University of Stanford
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Colorado
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Colorado Springs, Colorado, United States, 80920
- Orthopaedic and Spine Center of Southern Colorado
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Denver, Colorado, United States, 80222
- University of Colorado - Denver
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Illinois
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Rockford, Illinois, United States, 61107
- OrthoIllinois LTD
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- University Orthopedics Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Primary Care Clinic
Description
Inclusion Criteria:
Requires reattachment of soft tissue to bone for the following shoulder indications:
Rotator Cuff Tendon repair
- i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
- ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR
Biceps tenodesis
- i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
- ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST
Has a pre-operative standard of care MRI within 6 months of surgery containing the following sequences:
- Sat T2 FS: Oblique Sag T2-weighted Fat Saturation Spin Echo (oriented perpendicular to the scapula), with TE > 70 ms, AND
- Cor T2 FS: Oblique Cor T2-weighted Fat Saturation Spin Echo (oriented parallel to the scapula), with TE > 70 ms, AND
- Sag T1: Oblique Sag T1-weighted Spin Echo (oriented perpendicular to the scapula); OR
- Willing and able to undergo an additional study specific pre-operative MRI according to the study Imaging Protocol if the above criteria is not met OR
- MRI not required; subject not in HEALICOIL RG NST subgroup
- Has consented to participate in the study by signing the IRB/IEC approved informed consent form.
- Requires only one variant of the HEALICOIL Knotless Suture Anchor
- Is ≥18 years of age at time of surgery
- Willing and able to make all required study visits
- Able to follow instructions (Approved translated documents supplied upon request)
Exclusion Criteria:
Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
- Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
- Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
- Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
- Comminuted bone surface, which would compromise secure anchor fixation.
- Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing
- The presence of infection.
- Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
- Concurrent bilateral surgery.
- Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
- Women who are pregnant.
- Prior ipsilateral surgeries performed on the joint space.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HEALICOIL Knotless Suture REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB
|
HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping
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HEALICOIL Knotless PEEK
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK
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HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repair failure rate of HEALICOIL Knotless Suture Anchors
Time Frame: 6 months
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Repair failure rate defined as the need for a second repair procedure at 6 months.
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repair failure rate at 12 months and 24 months
Time Frame: 12 and 24 months
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Repair failure rate is defined as the need for a second repair procedure.
Repair rate at 24 months will be collected for the HEALICOIL Knotless REGENESORB Non-Self Tapping subgroup only.
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12 and 24 months
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Constant-Murley Score
Time Frame: 6, 12, and 24 months
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Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength.
The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function).
Pain and ADL are answered by the subject; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
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6, 12, and 24 months
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American Shoulder and Elbow Surgeons (ASES) Visual Analog Scale (VAS) pain score
Time Frame: 6, 12, and 24 months
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The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments.
The ASES score is a 0 to 100-point rating with a higher score indicating improvement in pain and function.
It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs).
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6, 12, and 24 months
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Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 months and 12 months
Time Frame: 6 and 12 months
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The SANE is a simple, single-question, patient-based shoulder function assessment tool: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
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6 and 12 months
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EQ-5D-3L at 6 months and 12 months
Time Frame: 6 and 12 months
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The EuroQol EQ-5D-3L is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses.
The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L dimension.
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6 and 12 months
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Tendon thickening and anchor absorption/replacement by bone at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping
Time Frame: 6 and 24 months
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Magnetic Resonance Imaging (MRI) will be used to determine tendon thickening and anchor absorption/replacement by bone at 6 and 24 months.
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6 and 24 months
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Tendon re-tear rate at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping only
Time Frame: 6 and 24 months
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Magnetic Resonance Imaging (MRI) will be used to determine tendon re-tear rate at 6 months and 24 months.
|
6 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Karlie Morgan, Smith & Nephew, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2020
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 9, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HEALICOIL.KNOTLESS.2019.12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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