Acetabular Labrum Tear, Anterior Shoulder Instability, Bankart Lesions, Labral Tear, Glenoid, Rotator Cuff Tears, SLAP Lesion
Conditions
Keywords
Microraptor, suture anchor, knotless, Smith and Nephew
Brief summary
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 315 subjects needing reattachment of soft tissue to bone.
Detailed description
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.
Interventions
DEVICEMICRORAPTOR™ REGENESORB™ Suture Anchor
Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.
DEVICEMICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.
DEVICEMICRORAPTOR™ Knotless PEEK Suture Anchor
The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject requires reattachment of soft tissue to bone for one of the following indications: * Shoulder - Capsular stabilization for Bankart repair, anterior shoulder instability, superior labrum from anterior to posterior (SLAP) lesion repairs, capsular shift or capsulolabral reconstructions; biceps tenodesis (knotless anchors only) * Hip - Acetabular labrum repair/reconstruction 2. Subject if ≥ 18 years of age or legally authorized representative if subject is \<18 years of age has consented to participate in the study by signing the IRB approved informed consent form. If \<18 years of age, subject has assented to participate in the study by signing the IRB approved assent form. 3. Subject is ≥12 years of age at time of surgery. 4. Willing and able to make all required study visits. 5. Able to follow instructions.
Exclusion criteria
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. Currently using tobacco products (cigarette, smokeless tobacco, e-cigarettes, vaping etc.). 9. Concurrent bilateral surgery. 10. Prior MICRORAPTOR™ REGENESORB™, MICRORAPTOR™ Knotless REGENESORB™ or MICRORAPTOR™ Knotless PEEK implantation. 11. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study. 12. Women who are pregnant or nursing. 13. History of poor compliance with medical treatment. 14. Prior ipsilateral surgeries performed on the joint space. 15. 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 |
|---|---|---|
| Repair Failure Rate at 6 Months | 6 months | Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repair Failure Rate at 12 Months | 12 months | Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up. |
| Visual Analogue Scale (VAS) Pain Change From Baseline | Baseline to 6 months, 12 months, and 24 months | Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity. Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome). A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome). The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
| Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY) | 24 months | Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor. Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up. |
| Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition | Baseline, 6 months, and 24 months | Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following: * Normal Intact Labrum * Labral Tear / Degeneration |
| Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion | Baseline, 6 months, and 24 months | Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following: * None * Mild * Moderate * Severe |
| Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema | Baseline, 6 months, and 24 months | Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema. The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'. |
| Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY) | Baseline to 6 months, 12 months, and 24 months | The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =\< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
| Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY) | Baseline to 6 months, 12 months, and 24 months | Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
| Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY) | Baseline to 6 months, 12 months, and 24 months | Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
| Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY) | Baseline to 6 months, 12 months, and 24 months | The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
| Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY) | Baseline to 6 months, 12 months, and 24 months | Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Countries
United States
Contacts
STUDY_CHAIRMary Ozokwere
Smith & Nephew, Inc.
Participant flow
Pre-assignment details
One Participant was excluded because the study device could not be used intraoperatively due to anchor failure.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.12 years STANDARD_DEVIATION 14.44 |
| Body Mass Index (BMI) | 27.32 kg/m^2 STANDARD_DEVIATION 5.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 297 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 122 | 0 / 61 |
| other Total, other adverse events | 37 / 114 | 35 / 122 | 13 / 61 |
| serious Total, serious adverse events | 6 / 114 | 7 / 122 | 2 / 61 |
Outcome results
None listed