Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip

Smith & Nephew, Inc.298 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

298

Conditions

Labral Tear, Glenoid Acetabular Labrum Tear Bankart Lesions Anterior Shoulder Instability SLAP Lesion Rotator Cuff Tears

Interventions

MICRORAPTOR™ REGENESORB™ Suture AnchorDEVICE

Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.

MICRORAPTOR™ Knotless REGENESORB™ Suture AnchorDEVICE

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.

MICRORAPTOR™ Knotless PEEK Suture AnchorDEVICE

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (12)

University of Colorado

Aurora, Colorado, United States

Colorado Springs Orthopaedic Group

Colorado Springs, Colorado, United States

Holy Cross Orthopedic Institute

Oakland Park, Florida, United States

Outcomes

Primary Outcomes

Repair Failure Rate at 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.

Time frame: 6 months

Secondary Outcomes

Repair Failure Rate at 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.

Time frame: 12 months

Visual Analogue Scale (VAS) Pain Change From Baseline

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.

Time frame: Baseline to 6 months, 12 months, and 24 months

Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Emory University - Brookhaven

Brookhaven, Georgia, United States

Luminis Health Research Institute

Annapolis, Maryland, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oklahoma Sports and Science Orthopedics / The Physician's Group

Oklahoma City, Oklahoma, United States

Palmetto/Prisma Health - University of South Carolina Orthopaedics

Columbia, South Carolina, United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, United States

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, United States

...and 2 more locations

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.

Time frame: 24 months

Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition

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

Time frame: Baseline, 6 months, and 24 months

Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion

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

Time frame: Baseline, 6 months, and 24 months

Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema

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'.

Time frame: Baseline, 6 months, and 24 months

Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)

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.

Time frame: Baseline to 6 months, 12 months, and 24 months

Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)

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.

Time frame: Baseline to 6 months, 12 months, and 24 months

Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)

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.

Time frame: Baseline to 6 months, 12 months, and 24 months

Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)

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.

Time frame: Baseline to 6 months, 12 months, and 24 months

Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)

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.

Time frame: Baseline to 6 months, 12 months, and 24 months