Clinical trial NCT03897387: Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthritis
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Dislocation rate of Medacta Versafit Cup DM
timeFrame: Minimum 2 years post surgery
measure: Implant position fixation and wear
timeFrame: Minimum 2 years post surgery
measure: Limb length
timeFrame: Minimum 2 years post surgery
measure: Patient Satisfaction and outcome score
timeFrame: Minimum 2 years post surgery
Secondary outcomes:
measure: Patient questionnaire Forgotten Joint Score (FJS)
timeFrame: Minimum 2 years post surgery
measure: Patient questionnaire Harris Hip Score (HHS)
timeFrame: Minimum 2 years post surgery
measure: Patient questionnaire Likert Scale Score
timeFrame: Minimum 2 years post surgery
measure: Gait analysis
timeFrame: Minimum 2 years post surgery
measure: Range of Motion
timeFrame: Minimum 2 years post surgery
measure: Implant survivorship
timeFrame: Minimum 2 years post surgery
measure: Surgical Approach
timeFrame: Minimum 2 years post surgery
measure: Implant demographics
timeFrame: Minimum 2 years post surgery
measure: Complications
timeFrame: Minimum 2 years post surgery
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Peak Orthopedics
state: Colorado
city: Libertyville
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
Study officials:
References: