Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
- Conditions
- Hip Arthritis
- Registration Number
- NCT03897387
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
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Subjects age 18 years and above at the time of consent
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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.
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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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Limb length Minimum 2 years post surgery Determined by radiographic analysis by measuring in millimeters
Implant position fixation and wear Minimum 2 years post surgery Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
Dislocation rate of Medacta Versafit Cup DM Minimum 2 years post surgery Determine radiographic analysis of component position in millimeters
Patient Satisfaction and outcome score Minimum 2 years post surgery Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score
- Secondary Outcome Measures
Name Time Method Patient questionnaire Harris Hip Score (HHS) Minimum 2 years post surgery Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Surgical Approach Minimum 2 years post surgery Chart review to determine anterior or posterior approach
Patient questionnaire Forgotten Joint Score (FJS) Minimum 2 years post surgery Assessment of awareness of the artificial joint in every day life using the FJS
Patient questionnaire Likert Scale Score Minimum 2 years post surgery Assessment of patient satisfaction using the Likert Scale
Range of Motion Minimum 2 years post surgery Assessment of contracture
Gait analysis Minimum 2 years post surgery Assessment of patient limp, use of assistive device
Implant survivorship Minimum 2 years post surgery Determine by radiographic analysis of bone fracture, implant fracture
Implant demographics Minimum 2 years post surgery Chart review to determine type of bearing in Versafit DM
Complications Minimum 2 years post surgery Chart review to determine adverse events and serious adverse events
Trial Locations
- Locations (3)
Peak Orthopedics
🇺🇸Lone Tree, Colorado, United States
Illinois Bone and Joint Institute
🇺🇸Libertyville, Illinois, United States
Texas Orthopedics
🇺🇸Austin, Texas, United States