Rotator Cuff
Conditions
Keywords
Rotator cuff, shoulder repair, HEALICOIL
Brief summary
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.
Interventions
DEVICEHEALICOIL Knotless PEEK
HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
DEVICEHEALICOIL Knotless REGENESORB
HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Requires reattachment of soft tissue to bone for the following shoulder indications: 1. 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 2. 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 2. Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria: 1. MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR 2. 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 3. MRI not required; subject not in HEALICOIL Knotless RG NST subgroup 3. Has consented to participate in the study by signing the IRB/IEC approved informed consent form. 4. Requires only one variant of the HEALICOIL Knotless Suture Anchor 5. Is ≥18 years of age at time of surgery 6. Willing and able to make all required study visits 7. 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: 1. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. 2. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation. 3. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture. 4. Comminuted bone surface, which would compromise secure anchor fixation. 5. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing 6. The presence of infection. 7. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period. 8. Concurrent bilateral surgery. 9. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study. 10. Women who are pregnant. 11. Prior ipsilateral surgeries performed on the joint space. 12. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate at 12 Months | 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. |
| Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY) | 24 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. |
| Constant-Murley Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| American Shoulder and Elbow Surgeons (ASES) Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months | Baseline, 6 months, 12 months, and 24 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). |
| EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score | Baseline, 6 months, 12 months, and 24 months | 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. |
| EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score | Baseline, 6 months, 12 months, and 24 months | 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). |
| Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | 6 months and 24 months | 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. |
| Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY) | 6 months and 24 months | 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'. |
Countries
United States
Contacts
STUDY_CHAIRKarlie Morgan
Smith & Nephew, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.60 years STANDARD_DEVIATION 8.95 |
| Body Mass Index (BMI) | 30.0 kg/m^2 STANDARD_DEVIATION 5.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants |
| Race/Ethnicity, Customized Race White | 120 Participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 75 Participants |
| Type of HEALICOIL Knotless Suture Anchor Non-Self Tapping | 67 Participants |
| Type of HEALICOIL Knotless Suture Anchor Self-Tapping | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 72 |
| other Total, other adverse events | 14 / 66 | 32 / 72 |
| serious Total, serious adverse events | 6 / 66 | 14 / 72 |
Outcome results
None listed