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

NCT03897387 | Completed

• 1 other identifier: MUSA-H-VDM-001
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 3

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.

Conditions

Hip Arthritis

Outcome Measures

Primary Outcomes (4)

• Dislocation rate of Medacta Versafit Cup DM

  Determine radiographic analysis of component position in millimeters

  Minimum 2 years post surgery

• Implant position fixation and wear

  Determine by radiographic analysis by measuring Radio Lucent lines in millimeters

  Minimum 2 years post surgery

• Limb length

  Determined by radiographic analysis by measuring in millimeters

  Minimum 2 years post surgery

• Patient Satisfaction and outcome score

  Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score

  Minimum 2 years post surgery

Secondary Outcomes (9)

• Patient questionnaire Forgotten Joint Score (FJS)

  Minimum 2 years post surgery

• Patient questionnaire Harris Hip Score (HHS)

  Minimum 2 years post surgery

• Patient questionnaire Likert Scale Score

  Minimum 2 years post surgery

• Gait analysis

  Minimum 2 years post surgery

• Range of Motion

  Minimum 2 years post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (3)

Peak Orthopedics

Lone Tree, Colorado, 80124, United States

Location

Illinois Bone and Joint Institute

Libertyville, Illinois, 60048, United States

Location

Texas Orthopedics

Austin, Texas, 78759, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2017
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (3)