Rotator CuffHEALICOIL_KNTLNCT04552119
Safety of Treatment of Shoulder Repair
An observational study of Rotator Cuff, run by Smith & Nephew, Inc. at 5 sites in United States.
Trial summary
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff
- What is being tested?
- HEALICOIL Knotless PEEK and HEALICOIL Knotless REGENESORB
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Jan 2021to 24 May 2024
- Phase
- Observational
- 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
Study population: Primary Care Clinic
Who may be able to join
- 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
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- 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 MRI collected within 6 months of surgery which meets one of the following criteria:
- MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR
- If standard-of-care images are unavailable or considered unacceptable by external imaging vendor, subject must undergo an additional study-specific pre- operative MRI, confirmed as acceptable by external imaging vendor OR
- MRI not required; subject not in HEALICOIL Knotless 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Orthopaedic and Spine Center of Southern Colorado
Colorado Springs, Colorado, 80920
University of Colorado - Denver
Denver, Colorado, 80222
University of Stanford
Redwood City, California, 94063
OrthoIllinois LTD
Rockford, Illinois, 61107
About this study
Official title: 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
Read the 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 either rotator cuff repair and/or biceps tenodesis. 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.
- Conditions
- Rotator Cuff
- Being tested
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Keywords
- Rotator cuff, shoulder repair, HEALICOIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALICOIL Knotless PEEKDevice
HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
HEALICOIL Knotless REGENESORBDevice
HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping
| Study group | Role | What they receive |
|---|---|---|
| HEALICOIL Knotless REGENESORB | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB Receives: Device: HEALICOIL Knotless REGENESORB | |
| HEALICOIL Knotless PEEK | HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK Receives: Device: HEALICOIL Knotless PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate at 6 Months
Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.
Measured: 6 months
Secondary outcomes (10)
Clinical Success Rate at 12 Months
Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.
Measured: 12 months
Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)
Clinical success identified by the repair failure rate was defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.
Measured: 24 months
Constant-Murley Score
Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology across four domains of pain, activities of daily living (ADL), range of motion (ROM), and strength. Pain and ADL are answered by the participant. ROM and strength require a physical evaluation and are answered by the surgeon or the physiotherapist. Scores range from 0 to 100, with a higher score indicating better shoulder function (i.e., a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
American Shoulder and Elbow Surgeons (ASES) Score
The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. 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). The ASES score ranges from 0 to 100 with a higher score indicating improvement in pain and function (i.e., a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. 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). The ASES VAS Pain score ranges from 0 to 10, where 0 represented no pain and 10 represented the worst pain (i.e., a lower score is a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
The SANE is a simple, single-question, patient-based shoulder function assessment tool based on responses to the question ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' Scores ranged from 0 to 100, where 100 was considered normal (i.e., a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
The EuroQol EQ-5D-3L is composed of a descriptive system and EQ Visual Analogue Scale (EQ VAS). The descriptive system measures health-related Quality of Life (QOL) that consists of five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on one of the three levels of severity (e.g., no problems, some or moderate problems, extreme problems) to create a combined Index Score. The Index Score is reported on a scale of 0 to 1 with a higher score indicating better health.
Measured: Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
The EuroQol EQ-5D-3L is composed of the descriptive system and EQ Visual Analogue Scale (EQ VAS). The EQ VAS was the participants self-rated health scored on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
Magnetic Resonance Imaging (MRI) was used to determine tendon thickening in millimeters (mm) for the supraspinatus tendon at the Lateral Anterior, Lateral Posterior, Medial Anterior, and Medial Posterior locations at 6 months and 24 months. Lateral measurements were taken from the lateral end of the supraspinatus tendon, about 5mm to the bony insertion site. Medial measurements considered the medial end of the supraspinatus tendon, about 5mm lateral to the musculotendinous junction.
Measured: 6 months and 24 months
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
Magnetic Resonance Imaging (MRI) was used to determine participant tendon Re-tear Status at 6 months and 24 months. Re-tear Status was categorized as either 'Absent' or 'Present' based on the Re-tear Type assessment. 'Absent' indicated a Re-tear Type graded as 'Intact', 'Low-grade Partial-Thickness Tear', or 'High-grade Partial-Thickness Tear'. 'Present' indicated a Re-tear Type graded as 'Full-Thickness Tear'.
Measured: 6 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start26 Jan 2021
- Primary completion24 May 2024
- Study completion24 May 2024
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 CuffStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552119
- Sponsor's protocol ID
- HEALICOIL.KNOTLESS.2019.12
- Acronym
- HEALICOIL_KNTL
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2020
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04552119
- Acronym / sponsor ID
- HEALICOIL_KNTL / HEALICOIL.KNOTLESS.2019.12
- Conditions
- Rotator Cuff
- Keywords
- Rotator cuff, shoulder repair, HEALICOIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
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 either rotator cuff repair and/or biceps tenodesis. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALICOIL Knotless REGENESORB | – | Device: HEALICOIL Knotless REGENESORBHEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB |
| HEALICOIL Knotless PEEK | – | Device: HEALICOIL Knotless PEEKHEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (16 listed)
- Requires reattachment of soft tissue to bone for the following shoulder indications:
- Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:
- 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
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| HEALICOIL Knotless PEEKHEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping | Device | HEALICOIL Knotless PEEK |
| HEALICOIL Knotless REGENESORBHEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping | Device | HEALICOIL Knotless REGENESORB |
Primary outcome
Clinical Success Rate at 6 Months
Time frame: 6 months
Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.
10 secondary outcomes
Clinical Success Rate at 12 Months
Time frame: 12 months
Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)
Time frame: 24 months
Constant-Murley Score
Time frame: Baseline, 6 months, 12 months, and 24 months
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, 6 months, 12 months, and 24 months
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months
Time frame: Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score
Time frame: Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
Time frame: 6 months and 24 months
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)
Time frame: 6 months and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karlie Morgan study chair
Smith & Nephew, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff, run by Smith & Nephew, Inc. at 5 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 16 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 16 Apr 2026). 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?
Clinical Success Rate at 6 Months (time frame: 6 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 16 Apr 2026.