Status:
UNKNOWN
OPS™ With Direct Anterior Approach (DAA)
Lead Sponsor:
Corin
Conditions:
Primary Total Hip Arthroplasty
Eligibility:
All Genders
21-85 years
Brief 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 ...
Detailed Description
Total Hip Replacement (THR) is the gold standard for treatment of severe arthritis of the hip as it relieves pain, restores function of the joint, and improves quality of life for patients. The restor...
Eligibility Criteria
Inclusion
- Patients who understand the conditions of the study and are willing to return to the clinical site at 2 weeks postoperatively.
- Patients of either gender who are between 21-85 years (inclusive) at the time of consent.
- Patients with a diagnosis of osteoarthritis (including post-traumatic osteoarthritis), rheumatoid arthritis or avascular necrosis 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
- Patients who are unable to provide informed consent.
- Patients who are unable to comply with all the required study procedures.
- Patients who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
Key Trial Info
Start Date :
January 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04319952
Start Date
January 13 2020
End Date
April 1 2023
Last Update
August 24 2021
Active Locations (2)
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1
Texas Orthopaedic Associates
Dallas, Texas, United States, 75225
2
Texas Orthopaedic Associates
Plano, Texas, United States, 75093