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Completed

NCT Number: NCT03897387

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peak Orthopedics, Lone Tree, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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