Hip Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Medacta USA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dislocation rate of Medacta Versafit Cup DM | Minimum 2 years post surgery | Determine radiographic analysis of component position in millimeters |
| Implant position fixation and wear | Minimum 2 years post surgery | Determine by radiographic analysis by measuring Radio Lucent lines in millimeters |
| Limb length | Minimum 2 years post surgery | Determined by radiographic analysis by measuring 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
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | Minimum 2 years post surgery | Assessment of contracture |
| Implant survivorship | Minimum 2 years post surgery | Determine by radiographic analysis of bone fracture, implant fracture |
| 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 |
| 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 |
| Surgical Approach | Minimum 2 years post surgery | Chart review to determine anterior or posterior approach |
| 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 |
| Patient questionnaire Likert Scale Score | Minimum 2 years post surgery | Assessment of patient satisfaction using the Likert Scale |
| Gait analysis | Minimum 2 years post surgery | Assessment of patient limp, use of assistive device |
Countries
United States
Outcome results
None listed