OPS™ With Direct Anterior Approach (DAA) (NCT04319952) | Clinical Trial Compass
UnknownNot Applicable
OPS™ With Direct Anterior Approach (DAA)
United States100 participantsStarted 2020-01-13
Plain-language 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.
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 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 Criteria:
* 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.
What they're measuring
1
Accuracy of the final osteotomy level compared to the selected OPS™ Plan