A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

NCT ID: NCT02196818

Last Updated: 2023-03-22

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

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2022-04-30

Brief Summary

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This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.

Detailed Description

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Conditions

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Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mpact Acetabular Shell

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

Mpact Acetabular Shell

Intervention Type DEVICE

Total Hip Replacement

Interventions

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Mpact Acetabular Shell

Total Hip Replacement

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

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vail Orthopedics, P.C.

Denver, Colorado, United States

Site Status

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

Illinois Bone & Joint Institute, LLC

Libertyville, Illinois, United States

Site Status

Jordan Valley Medical Center

West Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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P01.014.08/00

Identifier Type: -

Identifier Source: org_study_id

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