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

Hip Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897387
• Other study ID #: MUSA-H-VDM-001
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: March 2022
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis

Locations

Country	Name	City	State
United States	Texas Orthopedics	Austin	Texas
United States	Illinois Bone and Joint Institute	Libertyville	Illinois
United States	Peak Orthopedics	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dislocation rate of Medacta Versafit Cup DM	Determine radiographic analysis of component position in millimeters	Minimum 2 years post surgery
Primary	Implant position fixation and wear	Determine by radiographic analysis by measuring Radio Lucent lines in millimeters	Minimum 2 years post surgery
Primary	Limb length	Determined by radiographic analysis by measuring in millimeters	Minimum 2 years post surgery
Primary	Patient Satisfaction and outcome score	Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score	Minimum 2 years post surgery
Secondary	Patient questionnaire Forgotten Joint Score (FJS)	Assessment of awareness of the artificial joint in every day life using the FJS	Minimum 2 years post surgery
Secondary	Patient questionnaire Harris Hip Score (HHS)	Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score	Minimum 2 years post surgery
Secondary	Patient questionnaire Likert Scale Score	Assessment of patient satisfaction using the Likert Scale	Minimum 2 years post surgery
Secondary	Gait analysis	Assessment of patient limp, use of assistive device	Minimum 2 years post surgery
Secondary	Range of Motion	Assessment of contracture	Minimum 2 years post surgery
Secondary	Implant survivorship	Determine by radiographic analysis of bone fracture, implant fracture	Minimum 2 years post surgery
Secondary	Surgical Approach	Chart review to determine anterior or posterior approach	Minimum 2 years post surgery
Secondary	Implant demographics	Chart review to determine type of bearing in Versafit DM	Minimum 2 years post surgery
Secondary	Complications	Chart review to determine adverse events and serious adverse events	Minimum 2 years post surgery