OPS™ With Direct Anterior Approach (DAA)

Status unconfirmed

Conditions studied: Primary Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT04319952

Run by

Corin

People needed

100

Starts

2020-01-13

Expected to finish

2023-04-01

Last updated by the study team

2021-08-24

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 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.

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 who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

Where it is running

• Texas Orthopaedic Associates — Dallas, Texas, United States (enrolling)
• Texas Orthopaedic Associates — Plano, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.