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

Smith & Nephew

Status

Completed

Conditions

SLAP Lesion

Anterior Shoulder Instability

Bankart Lesions

Labral Tear, Glenoid

Acetabular Labrum Tear

Rotator Cuff Tears

Treatments

Device: MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor

Device: MICRORAPTOR™ Knotless PEEK Suture Anchor

Device: MICRORAPTOR™ REGENESORB™ Suture Anchor

Study type

Observational

Funder types

Industry

Identifiers

NCT03985839

2018.20.SMD.MRPTKT.PRO

Details and patient eligibility

About

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.

Full 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.

Enrollment

299 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion 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
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.

Exclusion criteria

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.