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

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ClinicalTrials.gov Identifier: NCT03897387
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medacta USA

Brief Summary:
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.

Condition or disease
Hip Arthritis

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Study Type : Observational
Estimated Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Dislocation rate of Medacta Versafit Cup DM [ Time Frame: Minimum 2 years post surgery ]
    Determine radiographic analysis of component position in millimeters

  2. Implant position fixation and wear [ Time Frame: Minimum 2 years post surgery ]
    Determine by radiographic analysis by measuring Radio Lucent lines in millimeters

  3. Limb length [ Time Frame: Minimum 2 years post surgery ]
    Determined by radiographic analysis by measuring in millimeters

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Patient questionnaire Likert Scale Score [ Time Frame: Minimum 2 years post surgery ]
    Assessment of patient satisfaction using the Likert Scale

  4. Gait analysis [ Time Frame: Minimum 2 years post surgery ]
    Assessment of patient limp, use of assistive device

  5. Range of Motion [ Time Frame: Minimum 2 years post surgery ]
    Assessment of contracture

  6. Implant survivorship [ Time Frame: Minimum 2 years post surgery ]
    Determine by radiographic analysis of bone fracture, implant fracture

  7. Surgical Approach [ Time Frame: Minimum 2 years post surgery ]
    Chart review to determine anterior or posterior approach

  8. Implant demographics [ Time Frame: Minimum 2 years post surgery ]
    Chart review to determine type of bearing in Versafit DM

  9. Complications [ Time Frame: Minimum 2 years post surgery ]
    Chart review to determine adverse events and serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897387


Contacts
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Contact: Mukesh Ahuja, CPI, MBBS, MS 312-548-9968 mahuja@medacta.us.com

Locations
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United States, Colorado
Peak Orthopedics Recruiting
Lone Tree, Colorado, United States, 80124
Principal Investigator: Robert Greenhow, MD         
United States, Illinois
Illinois Bone and Joint Institute Recruiting
Libertyville, Illinois, United States, 60048
Contact: Peter Thadani, MD    847-247-4000    pthadani@ibji.com   
United States, Texas
Texas Orthopedics Recruiting
Austin, Texas, United States, 78759
Contact: Tyler Goldberg, MD    512-439-1001    tgoldberg@texasorthopedics.com   
Principal Investigator: Tyler Goldberg, MD         
Sponsors and Collaborators
Medacta USA

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Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03897387     History of Changes
Other Study ID Numbers: MUSA-H-VDM-001
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases