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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03897595

Enrollment

187

Registered

2019-04-01

Start date

2012-10-31

Completion date

2022-03-30

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

Brief summary

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

Interventions

DEVICEMPact 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026