Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897595
• Other study ID #: P01.014.08/01
• Status: Completed
• Start date: October 2012
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2023
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

• Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).

• Patients must be willing to comply with the pre and post-operative evaluation schedule

Exclusion Criteria:

• Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• MPact Cup
Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head

Locations

Country	Name	City	State
United States	Saint Alphonsus Medical Group	Boise	Idaho
United States	Illinois Bone and Joint Institute	Libertyville	Illinois
United States	McBride Orthopedic Hospital	Oklahoma City	Oklahoma
United States	Denver Vail Orthopedics	Parker	Colorado
United States	Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Harris Hip Scores (HHS)	Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores	Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Primary	Change from baseline of implant survivorship	Assessment of bone fracture, implant fracture, neck reabsorption	Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Primary	Change in baseline of Complications	Assessment of Adverse events and serious adverse events	Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Primary	Change in baseline fixation and wear	Radiographic analysis by measuring Radio Lucent Lines	Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Primary	Change in baseline fixation	Radiographic analysis by measuring implant fixation in millimeters	Post-operative 3 or 6 months, 1 year, 2 year and 5 year