PMCF Study on PEEK Suture Anchors for Shoulder Indications

N/ACompletedNCT03826667

Smith & Nephew, Inc.464 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

464

Conditions

Soft Tissue to Bone Fixation

Interventions

Polyetheretherketone (PEEK) Shoulder Suture AnchorsDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Grandview Medical Center

Birmingham, Alabama, United States

OrthoArizona

Phoenix, Arizona, United States

University of Colorado- Denver

Denver, Colorado, United States

Outcomes

Primary Outcomes

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

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

Time frame: 6 months

Secondary Outcomes

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

Visual Analog Scale (VAS) - Pain

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.

Time frame: 6 and 12 months

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

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

Time frame: 6 and 12 months

Range of Motion (ROM)

Data from ClinicalTrials.gov

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