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

• Sponsor: Medacta International SA (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02196818
• Collaborator: (none)
• Enrollment: 200
• Locations: 4
• Duration (Months): 137
• Patients Per Site: 50
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia	Device: Mpact Acetabular Shell

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Mpact Acetabular Shell Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.	Device: Mpact Acetabular Shell; Total Hip Replacement

Outcome Measures

Primary Outcome Measures

1. The Kaplan-Meier analysis as a measure of implant performance. [5 years]

Secondary Outcome Measures

1. The Harris Hip Score. [pre-op, 3/6 months, 1,2 and 5 years]

2. Radiological analysis as a meausure of safety. [3/6 months, 1,2 and 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vail Orthopedics, P.C.	Denver	Colorado	United States	80230
2	Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83702
3	Illinois Bone & Joint Institute, LLC	Libertyville	Illinois	United States	60048
4	Jordan Valley Medical Center	West Jordan	Utah	United States	84088

Sponsors and Collaborators

• Medacta International SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medacta International SA
• ClinicalTrials.gov Identifier: NCT02196818
• Other Study ID Numbers: P01.014.08/00
• First Posted: Jul 22, 2014
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis

Study Results

No Results Posted as of Sep 2, 2020