Accuracy of OPS™ Femoral Neck Resection Study

Completed

Conditions studied: Primary Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT03956381

Run by

Corin

People needed

55

Starts

2019-04-24

Expected to finish

2021-07-31

Last updated by the study team

2021-09-24

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Colorado Joint Replacement — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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