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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Subjects age 18 years and above at the time of consent
2. 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.

4\. 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes