Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op

Completed

Conditions studied: Hip Arthritis

In brief

This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.

Key facts

Study ID

NCT03897387

Run by

Medacta USA

People needed

316

Starts

2017-03-01

Expected to finish

2022-03-30

Last updated by the study team

2022-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects age 18 years and above at the time of consent
• Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. Written informed consent must be obtained prior to any study procedure. 3 Patients must be willing to comply with the prospective visit schedule.
• Patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.). 5. Patients must have received a Medacta Versafit Cup DM component 6. Patient must have adequate pre-operative and post-operative radiographs 7. Patients must be at minimum 2 year (24 months) post-treatment 8. The operation was performed by the investigator.

You may not qualify if…

• History of alcoholism
• Currently on chemotherapy or radiation therapy
• Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain
• History of a metabolic disorder such as Gout affecting the skeletal system other than osteoarthritis or osteoporosis
• History of chronic pain issues for reasons other than hip pain
• Women that are pregnant
• Patients who underwent Total Hip Arthroplasty (THA) using standard polyethylene

Where it is running

• Peak Orthopedics — Lone Tree, Colorado, United States
• Illinois Bone and Joint Institute — Libertyville, Illinois, United States
• Texas Orthopedics — Austin, Texas, United States

Full record on ClinicalTrials.gov

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