Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
1 other identifier
observational
299
1 country
12
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 300 subjects needing reattachment of soft tissue to bone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedMarch 17, 2025
November 1, 2023
5 years
June 11, 2019
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repair failure rate
To assess repair failure rate at 6 months
6 months
Secondary Outcomes (8)
Repair failure rate
12 months
ROWE shoulder score
6 and 12 months
WOSI shoulder score
6 and 12 months
Constant-Murley Shoulder Scale
6 and 12 months
HOS-ADL Score
6 and 12 months
- +3 more secondary outcomes
Study Arms (3)
MICRORAPTOR™ REGENESORB™ Suture Anchor
MICRORAPTOR™ REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless PEEK Suture Anchor
MICRORAPTOR™ Knotless PEEK Suture Anchor
Interventions
Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.
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.
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 Criteria
Subject requires reattachment of soft tissue to bone for the following indications: * Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only) * Hip - Acetabular labrum repair/reconstruction
You may qualify if:
- Subject requires reattachment of soft tissue to bone for the following indications:
- Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only)
- Hip - Acetabular labrum repair/reconstruction
- Subject has consented to participate in the study by signing the EC-approved informed consent form.
- Subject is ≥18 years of age at time of surgery.
- Willing and able to make all required study visits.
- Able to follow instructions.
You may not qualify if:
- 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.
- Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.).
- Concurrent bilateral surgery.
- Prior MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB, or MICRORAPTOR Knotless PEEK implantation.
- Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
- Women who are pregnant or nursing.
- History of poor compliance with medical treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Colorado
Aurora, Colorado, 80045, United States
Colorado Springs Orthopaedic Group
Colorado Springs, Colorado, 80920, United States
Holy Cross Orthopedic Institute
Oakland Park, Florida, 33334, United States
Emory University - Brookhaven
Brookhaven, Georgia, 30329, United States
Luminis Health Research Institute
Annapolis, Maryland, 21401, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43202, United States
Oklahoma Sports and Science Orthopedics / The Physician's Group
Oklahoma City, Oklahoma, 73114, United States
Palmetto/Prisma Health - University of South Carolina Orthopaedics
Columbia, South Carolina, 29203, United States
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615, United States
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, 23452, United States
Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
Woodbridge, Virginia, 22191, United States
Memorial Medical Center
Ashland, Wisconsin, 54806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mary Ozokwere
Smith & Nephew, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 14, 2019
Study Start
August 1, 2019
Primary Completion
August 8, 2024
Study Completion
August 8, 2024
Last Updated
March 17, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share