Safety and Performance of PEEK Anchors in Extremities

NCT03782298 | Completed Results

• 1 other identifier: 2018.15.SMD.PEEK.RET.EXT
• Study Type: observational
• Target: 140
• Locations: 2 countries
• Sites: 4

Brief Summary

Safety and performance of the study devices in extremities up to 12 months post-surgery

Conditions

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

Keywords

Dynomite; Spyromite; Raptormite; Foot; Ankle; Wrist; Hand; Elbow; Footprint

Outcome Measures

Primary Outcomes (1)

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

  Clinical success was defined as extremity 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 extremity

  6 months

Secondary Outcomes (1)

• Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention

  12 months

Other Outcomes (2)

• Visual Analog Scale (VAS) - Pain

  6 and 12 months

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

  6 and 12 months

Interventions

Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL DEVICE

PEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (4)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Precision Orthopaedic Specialties, Inc.

Chardon, Ohio, 44024, United States

Location

Foot and Ankle Associates of North Texas-Grapevine

Grapevine, Texas, 76051, United States

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Results Point of Contact

• Title: Judith Horner
• Organization: Smtih + Nephew, Inc

Judith.horner@smith-nephew.com

+44 1482 673251

Study Officials

• Judth Horner

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 20, 2018
• Study Start: March 12, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 1, 2024
• Results First Posted: September 24, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)