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

March 30, 2022 updated by: Medacta USA

A Post-market, Multi-center, Retrospective Study to Identify Clinical Outcomes and Complications Data From Patients Implanted With the Medacta Versafit Cup DM Prosthesis Who Are at Least Two Years Post Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Peak Orthopedics
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Illinois Bone And Joint Institute
    • Texas
      • Austin, Texas, United States, 78759
        • Texas Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to a total of 528 qualified patients who have undergone primary or revision Total Hip Arthroplasty (THA) will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dislocation rate of Medacta Versafit Cup DM
Time Frame: Minimum 2 years post surgery
Determine radiographic analysis of component position in millimeters
Minimum 2 years post surgery
Implant position fixation and wear
Time Frame: Minimum 2 years post surgery
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
Minimum 2 years post surgery
Limb length
Time Frame: Minimum 2 years post surgery
Determined by radiographic analysis by measuring in millimeters
Minimum 2 years post surgery
Patient Satisfaction and outcome score
Time Frame: Minimum 2 years post surgery
Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score
Minimum 2 years post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient questionnaire Forgotten Joint Score (FJS)
Time Frame: Minimum 2 years post surgery
Assessment of awareness of the artificial joint in every day life using the FJS
Minimum 2 years post surgery
Patient questionnaire Harris Hip Score (HHS)
Time Frame: Minimum 2 years post surgery
Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Minimum 2 years post surgery
Patient questionnaire Likert Scale Score
Time Frame: Minimum 2 years post surgery
Assessment of patient satisfaction using the Likert Scale
Minimum 2 years post surgery
Gait analysis
Time Frame: Minimum 2 years post surgery
Assessment of patient limp, use of assistive device
Minimum 2 years post surgery
Range of Motion
Time Frame: Minimum 2 years post surgery
Assessment of contracture
Minimum 2 years post surgery
Implant survivorship
Time Frame: Minimum 2 years post surgery
Determine by radiographic analysis of bone fracture, implant fracture
Minimum 2 years post surgery
Surgical Approach
Time Frame: Minimum 2 years post surgery
Chart review to determine anterior or posterior approach
Minimum 2 years post surgery
Implant demographics
Time Frame: Minimum 2 years post surgery
Chart review to determine type of bearing in Versafit DM
Minimum 2 years post surgery
Complications
Time Frame: Minimum 2 years post surgery
Chart review to determine adverse events and serious adverse events
Minimum 2 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSA-H-VDM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Arthritis

3
Subscribe