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PMCF Study on PEEK Suture Anchors for Shoulder Indications

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ClinicalTrials.gov Identifier: NCT03826667
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

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

Condition or disease Intervention/treatment
Soft Tissue to Bone Fixation Device: PEEK Suture Anchors

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: PMCF Study on PEEK Suture Anchors for Shoulder Indications
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : June 15, 2020

Intervention Details:
  • Device: PEEK Suture Anchors

    Subjects who have received PEEK Suture Anchors in the shoulder:

    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, SpeedScrew, SpeedLock



Primary Outcome Measures :
  1. Clinical success of the study devices in the shoulder over a time period of 6 months after intervention [ Time Frame: 6 months ]
    Clinical success is defined as the number of device failures in the shoulder


Secondary Outcome Measures :
  1. Clinical success of the study devices in the shoulder over a time period of 12 months after intervention [ Time Frame: 12 months ]
    Clinical success is defined as the number of device failures in the shoulder

  2. Visual Analog Scale (VAS) - pain [ Time Frame: 12 months ]
    he VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: No Stiffness (0 mm) and Extreme Stiffness (100 mm). The VAS rating will be recorded retrospectively, per standard of care at 6 and 12 months post-surgery.

  3. Range of Motion (ROM) [ Time Frame: 12 months ]
    Flexion, extension, abduction, adduction, external/internal rotation will be captured in degrees based on physican's Standard of Care for this retrospective study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have received PEEK Suture Anchors implanted in the shoulder
Criteria

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.

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): NCT03826667


Contacts
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Contact: Sandra Navarette 512-895-1086 Sandra.navarrete@smith-nephew.com

Locations
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United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35242
Contact: David Lemak, MD    205-971-8000    Lindsey.Gordon@grandviewhealth.com   
Principal Investigator: David Lemak, MD         
United States, Arizona
OrthoArizona Recruiting
Phoenix, Arizona, United States, 85018
Contact: Keith Jarbo    602-631-3161    kjarbo@OrthoArizona.org   
Principal Investigator: Keith Jarbo, MD         
United States, Colorado
University of Colorado- Denver Recruiting
Denver, Colorado, United States, 80222
Contact: Johnathan Bravman, MD    720-848-8200    Jonathan.Bravman@ucdenver.edu   
Principal Investigator: Jonathan Bravman, MD         
United States, Florida
Holy Cross Hospital/Orthopedic Institute Recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Jonathan Levy    954-958-4800    jonlevy123@yahoo.com   
Principal Investigator: Johnathan Levy, MD         
United States, Georgia
OrthoAtlanta Recruiting
Lawrenceville, Georgia, United States, 30046
Contact: Snehal Dalal, MD    678-957-0757    shanell.disla@holy-cross.com   
Principal Investigator: Snehal Dalal, MD         
United States, Oklahoma
Community Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73114
Contact: Ryan Nelson    405-419-3978    rnelsdo@gmail.com   
Principal Investigator: Ryan Nelson, MD         
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robin Stern, RN, CCRC    814-942-0081 ext 4235    rstern@uoc.com   
Contact: Penny Adams, LPN, CRC       padams@uoc.com   
Principal Investigator: William A. Tyndall, MD, PhD         
United States, Texas
Houston Methodist at Baytown Recruiting
Baytown, Texas, United States, 77521
Contact: David Lintner, MD    832-556-0880    ddong@houstonmethodist.org   
Principal Investigator: David Lintner, MD         
Texas Orthopedic Hospital - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Thomas Edwards, MD    713-779-2300    Aidee.Salinas@fondren.com   
Principal Investigator: Thomas Edwards, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hanson, MD, PhD Vice President, Global Clinical Strategy

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03826667     History of Changes
Other Study ID Numbers: 2018.16.SMD.PEEK.RET.SHD
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 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