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Accuracy of OPS™ Femoral Neck Resection Study

NCT03956381 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2021-09-24

No results posted yet for this study

Summary

The primary objective of this study is to determine the accuracy of the Optimized Positioning System (OPS™) planning and delivery tools using different types of surgical approaches.

Conditions

  • Primary Total Hip Arthroplasty

Interventions

DEVICE

Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach.

The participant will undergo surgery using the hip prostheses and surgical approach used by their surgeon Investigator. A patient specific femoral guide, generated by the OPS™ plan preoperatively, will be used during the surgical step of femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.

DEVICE

Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach

The participant will undergo surgery using the hip prostheses and surgical approach used by their surgeon Investigator. A patient specific femoral guide, generated by the OPS™ plan preoperatively, will be used during the surgical step of femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.

Sponsors & Collaborators

  • Corin

    lead INDUSTRY

Principal Investigators

  • Jason Jennings, MD · Colorado Joint Replacement

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2021-06-15
Completion
2021-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956381 on ClinicalTrials.gov