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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-08-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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MICRORAPTOR™ REGENESORB™ Suture Anchor

Intervention Type DEVICE

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

Intervention Type DEVICE

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 Anchor

Intervention Type DEVICE

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.

Interventions

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MICRORAPTOR™ REGENESORB™ Suture Anchor

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

Intervention Type DEVICE

MICRORAPTOR™ 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.

Intervention Type DEVICE

MICRORAPTOR™ 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No