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Completed

NCT Number: NCT04893824

Grappler® Interference Screw Post-Market Clinical Follow-Up Study

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

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Key information

About this study

This is a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).

Who can participate

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

Inclusion criteria

  • The subject must have undergone a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
  • The subject must have adequate radiographic and medical records for the minimum follow-up requirement of six months

For the Prospective Data Collection:

  • The subject is willing to provide written informed consent

Exclusion criteria

  • None

Treatment and study plan

Grappler® Interference Screw System

Device

Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Primary outcomes

  1. Incidence of revisions

    Time frame: 6 Months Post-Op

    Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation.

  2. Incidence of adverse events

    Time frame: 6 Months Post-Op

    Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation.

  3. Incidence of complications

    Time frame: 6 Months Post-Op

    Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation.

Secondary outcomes

  1. Rate of recurrence of deformity

    Time frame: 7 Weeks Post-Op, 6 Months Post-Op

    Safety as related to rate of recurrence of deformity

  2. Rate of implant failure

    Time frame: Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op

    Safety as related to rate of implant failure

  3. Rate of re-tear or re-rupture of fixated soft tissue

    Time frame: 7 Weeks Post-Op, 6 Months Post-Op

    Safety as related to rate of re-tear or re-rupture of fixated soft tissue

  4. Rate of screw removal

    Time frame: 7 Weeks Post-Op, 6 Months Post-Op

    Safety as related to rate of screw removal

  5. Foot and Ankle Mobility Measure

    Time frame: 6 months post-operative

    Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.

  6. Visual Analog Scale

    Time frame: 6 months post-operative

    Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable)

  7. Patient satisfaction

    Time frame: 6 months post-operative

    Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)

Sponsors and collaborators

Lead sponsor

Paragon 28

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 20, 2021
Registry last updated
Nov 15, 2023

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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