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

NCT ID: NCT03897595

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2022-03-30

Brief Summary

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

Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

MPact Cup

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medacta USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Denver Vail Orthopedics

Parker, Colorado, United States

Site Status

Saint Alphonsus Medical Group

Boise, Idaho, United States

Site Status

Illinois Bone and Joint Institute

Libertyville, Illinois, United States

Site Status

McBride Orthopedic Hospital

Oklahoma City, Oklahoma, United States

Site Status

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

West Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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P01.014.08/01

Identifier Type: -

Identifier Source: org_study_id

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