CompletedNot Applicable

Accuracy of OPS™ Femoral Neck Resection Study

United States55 participantsStarted 2019-04-24

Plain-language 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.

Who can participate

Age range21 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patients who understand the conditions of the study and are willing to return to the clinical site at 6 weeks post-operatively.
✓. Patients of either gender who are between 21-85 years inclusive.
✓. Patients with a diagnosis of osteoarthritis, rheumatoid arthritis or osteonecrosis and are considered by the Investigator to be clinically and medically suitable to undergo a primary total hip replacement
✓. Patients who meet the indications and none of the contraindications listed in the Instructions for Use (IFU) supplied by the manufacturer for the femoral stem and acetabular cup to be implanted.
✓. Patients who meet the indications and none of the contraindications listed in the Instructions for Use (IFU) supplied by the manufacturer for OPS™ Femoral Plan and OPS™ Femoral Patient Specific Instruments.

Exclusion criteria

✕. Patients who are unable to provide informed consent.
✕. Patients who are unable to comply with all the required study procedures.
✕. Patients whose insurance will not cover the cost of the pre-operative CT and functional x-ray imaging required for use of the OPS system.
✕. Patients who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

What they're measuring

Accuracy of the final osteotomy level compared to the selected OPS™ plan preopertively.

Timeframe: 6 weeks post-op (+/- 2 weeks)

Trial details

NCT IDNCT03956381

SponsorCorin

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-15

View on ClinicalTrials.gov More Primary Total Hip Arthroplasty trials