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OPS™ With Direct Anterior Approach (DAA)

NCT04319952 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-08-24

No results posted yet for this study

Summary

A prospective, non-randomized, single-center clinical study to determine the accuracy of a patient-specific instrument (OPS™) for delivering a planned femoral component anteversion and neck resection using a Direct Anterior Approach (DAA) in Total Hip Arthroplasy.

Conditions

  • Primary Total Hip Arthroplasty

Interventions

DEVICE

Primary Total Hip Replacement with Metafix™ femoral stem and Trinity™ acetabular cup or TriFit-CF™/TriFit-TS™ femoral stem and Trinity™ acetabular cup implanted by a single surgeon.

The participant will undergo surgery using the hip prostheses and direct anterior 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 the femoral neck resection. These are not study specific procedures as the OPS™ Plan is already in use by the surgeon-investigator in their standard of care practice.

Sponsors & Collaborators

  • Corin

    lead INDUSTRY

Principal Investigators

  • Donald W Hohman, MD · Surgical Education & Research LLC

Eligibility

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

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2023-01-31
Completion
2023-04-30

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 NCT04319952 on ClinicalTrials.gov