- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897387
Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Colorado
-
Lone Tree, Colorado, United States, 80124
- Peak Orthopedics
-
-
Illinois
-
Libertyville, Illinois, United States, 60048
- Illinois Bone And Joint Institute
-
-
Texas
-
Austin, Texas, United States, 78759
- Texas Orthopedics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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:
- 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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dislocation rate of Medacta Versafit Cup DM
Time Frame: Minimum 2 years post surgery
|
Determine radiographic analysis of component position in millimeters
|
Minimum 2 years post surgery
|
Implant position fixation and wear
Time Frame: Minimum 2 years post surgery
|
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
|
Minimum 2 years post surgery
|
Limb length
Time Frame: Minimum 2 years post surgery
|
Determined by radiographic analysis by measuring in millimeters
|
Minimum 2 years post surgery
|
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
|
Minimum 2 years post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Minimum 2 years post surgery
|
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
|
Minimum 2 years post surgery
|
Patient questionnaire Likert Scale Score
Time Frame: Minimum 2 years post surgery
|
Assessment of patient satisfaction using the Likert Scale
|
Minimum 2 years post surgery
|
Gait analysis
Time Frame: Minimum 2 years post surgery
|
Assessment of patient limp, use of assistive device
|
Minimum 2 years post surgery
|
Range of Motion
Time Frame: Minimum 2 years post surgery
|
Assessment of contracture
|
Minimum 2 years post surgery
|
Implant survivorship
Time Frame: Minimum 2 years post surgery
|
Determine by radiographic analysis of bone fracture, implant fracture
|
Minimum 2 years post surgery
|
Surgical Approach
Time Frame: Minimum 2 years post surgery
|
Chart review to determine anterior or posterior approach
|
Minimum 2 years post surgery
|
Implant demographics
Time Frame: Minimum 2 years post surgery
|
Chart review to determine type of bearing in Versafit DM
|
Minimum 2 years post surgery
|
Complications
Time Frame: Minimum 2 years post surgery
|
Chart review to determine adverse events and serious adverse events
|
Minimum 2 years post surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUSA-H-VDM-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Arthritis
-
Centre de l'arthrose, ParisRecruiting
-
Rutgers, The State University of New JerseyRecruitingTotal Hip Arthroplasty | Hip ArthritisUnited States
-
Klinički Bolnički Centar ZagrebUnknownHip Fractures | Knee Fracture | Knee Arthritis | Hip ArthritisCroatia
-
Kuopio University HospitalCompletedHip Arthritis | Total Hip Arthroplasty (THA)Finland
-
Göteborg UniversityCompletedTotal Hip Arthroplasty | Hip Arthritis | Gait AnalysisSweden
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Ottawa Hospital Research InstituteRecruitingHip Osteoarthritis | Hip ArthritisCanada
-
Massachusetts General HospitalZimmer BiometUnknownOsteoarthritis of Hip | Traumatic Arthritis of HipUnited States
-
Massachusetts General HospitalZimmer BiometActive, not recruitingOsteoarthritis of Hip | Traumatic Arthritis of HipUnited States
-
gosta ullmarkUnknownHip Osteo ArthritisSweden