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Completed

NCT Number: NCT03826667

PMCF Study on PEEK Suture Anchors for Shoulder Indications

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

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Key information

Conditions

Soft Tissue to Bone Fixation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grandview Medical Center, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects who are < 12 months post-operative.
  • 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.

Treatment and study plan

Polyetheretherketone (PEEK) Shoulder Suture Anchors

Device

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

Primary outcomes

  1. Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention

    Time frame: 6 months

    Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:

    • no inflammatory or allergic response
    • no device-related adverse event (AE)
    • no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder

Secondary outcomes

  1. Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention

    Time frame: 12 months

    Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:

    • no inflammatory or allergic response
    • no device-related adverse event (AE)
    • no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder

  2. Visual Analog Scale (VAS) - Pain

    Time frame: 6 and 12 months

    The 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. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.

  3. Count of Participants With Range of Motion (ROM) Full Functional Arc

    Time frame: 6 and 12 months

    Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.

  4. Range of Motion (ROM)

    Time frame: 6 and 12 months

    Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2019
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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