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Trial record 97 of 183 for:    RET

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782298
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

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

Condition or disease Intervention/treatment
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 Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : September 17, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
    Observational, post-market, clinical follow-up study


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. Range of Motion (ROM) [ Time Frame: 12 months ]
    Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782298


Contacts
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Contact: Sandra Navarrete 512-895-1086 Sandra.Navarrete@smith-nephew.com
Contact: Shirley Mak-Parisi (978)749-1459 Shirley.Mak-parisi@smith-nephew.com

Locations
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United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Amy Roznowksy    704-323-3697    Amy.Roznowski@orthocarolina.com   
Contact: Rebekah Alsop    704-323-3697    Rebekah.Alsop@orthocarolina.com   
Principal Investigator: Carroll Jones, MD         
United States, Ohio
Precision Orthopaedic Specialties, Inc. Recruiting
Chardon, Ohio, United States, 44024
Contact: Elizabeth Sanders    414-630-2388    elizabeth.sanders014@gmail.com   
Principal Investigator: Mark Mendeszoon, DPM         
United States, Texas
Foot and Ankle Associates of North Texas-Grapevine Recruiting
Grapevine, Texas, United States, 76051
Contact: Paul Steinke, MD    817-627-8271    paul.steinke1@gmail.com   
Principal Investigator: Paul Steinke, MD         
Bear Creek Surgery Center Recruiting
Keller, Texas, United States, 76248
Contact: Nathan Stickney, MD    817-416-6155    nstickney5@gmail.com   
Principal Investigator: Nathan Stickney, MD         
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic Recruiting
London, Ontario, Canada, N6A 3K7
Principal Investigator: Kevin Willits         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Sandra Navarrete Smith & Nephew, Inc.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03782298     History of Changes
Other Study ID Numbers: SMD.PEEK.RET.EXT
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Smith & Nephew, Inc.:
Dynomite
Spyromite
Raptormite
Foot
Ankle
Wrist
Hand
Elbow
Additional relevant MeSH terms:
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Tennis Elbow
Hallux Valgus
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Foot Deformities