Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities

June 16, 2020 updated by: Smith & Nephew, Inc.

Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities

Safety and performance of the study devices in extremities over a time period of 6 months after intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic
  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina
    • Ohio
      • Chardon, Ohio, United States, 44024
        • Precision Orthopaedic Specialties, Inc.
    • Texas
      • Grapevine, Texas, United States, 76051
        • Foot and Ankle Associates of North Texas-Grapevine
      • Keller, Texas, United States, 76248
        • Bear Creek Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors (Dynomite, Spyromite, Raptomite, Footprint Ultra PK SL)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and performance of the study devices in extremities over a time period of 6 months after intervention.
Time Frame: 6 months
Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and performance of the study devices in extremities over a time period of 12 months after intervention
Time Frame: 12 months
Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) - pain
Time Frame: 12 months
0 to 10 is the scoring range of pain for the joint that received treatment with the anchor
12 months
Range of Motion (ROM)
Time Frame: 12 months
Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Study Chair: Judth Horner, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2019

Primary Completion (ACTUAL)

August 15, 2019

Study Completion (ACTUAL)

August 15, 2019

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (ACTUAL)

December 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD.PEEK.RET.EXT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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