Safety and Performance of PEEK Anchors in Extremities

NCT ID: NCT03782298

Last Updated: 2024-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-12

Study Completion Date

2019-10-10

Brief Summary

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Safety and performance of the study devices in extremities up to 12 months post-surgery

Detailed Description

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Conditions

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Medial or Lateral Instability Repairs/Reconstructions Hallux Valgus Repairs Achilles Tendon Repairs/Reconstructions Midfoot Reconstructions Metatarsal Ligament/Tendon Repairs/Reconstructions Bunionectomy Scapholunate Ligament Reconstructions Ulnar Lateral Epicondylitis Repair Bicep Tendon Reattachments

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

PEEK Suture Anchors, which include:

* SPYROMITE™ 2.0 PK Suture Anchor with Needles
* DYNOMITE™ 2.0 PK Suture Anchor with Needles
* RAPTORMITE™ 3.0 Suture Anchor with Needles
* FOOTPRINT™ Ultra PK SL Suture Anchor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
* Subjects who are \< 3 months post-operative
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judth Horner

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

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OrthoCarolina

Charlotte, North Carolina, United States

Site Status

Precision Orthopaedic Specialties, Inc.

Chardon, Ohio, United States

Site Status

Foot and Ankle Associates of North Texas-Grapevine

Grapevine, Texas, United States

Site Status

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018.15.SMD.PEEK.RET.EXT

Identifier Type: -

Identifier Source: org_study_id

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