PMCF Study on PEEK Suture Anchors for Shoulder Indications

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2019-08-28

Brief Summary

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Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.

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Detailed Description

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Conditions

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Soft Tissue to Bone Fixation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Polyetheretherketone (PEEK) Shoulder Suture Anchors

PEEK Suture Anchors, which include:

* HEALICOIL™ PK Preloaded Suture Anchors
* BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
* BIORAPTOR™ Knotless Suture Anchors
* MULTIFIX™ S Ultra Knotless Fixation System
* FOOTPRINT™ Ultra PK Suture Anchors
* TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
* SPEEDSCREW™ Knotless Fixation System
* SpeedLock Knotless Fixation Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects who have undergone shoulder joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria

1. Subjects who are \< 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No