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NCT02846636 Clinical Trial

Mpact Cup Performance After Total Hip Arthroplasty

Total Hip Replacement Clinical Trial

Official title:
Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT02846636
Other study ID # P01.014.07
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date August 2014
Est. completion date April 2029

Study information
Verified date October 2023
Source Medacta International SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

Recruitment information / eligibility
Status Suspended
Enrollment 100
Est. completion date April 2029
Est. primary completion date April 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients requiring a total hip replacement who meets the standard indications for use for Medacta implants - patients who accept to participate in the study - patients who signed the consent form for the treatment of personal data Exclusion Criteria: - patients presenting conditions identified as contraindication for Medacta implants - revision surgeries

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Clinique Médico-Chirurgicale Paris V Paris

Sponsors (1)
Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary implant survival trough Kaplan-Meier curve 10 years
Secondary hip function with Harris Hip Score preop, 3/6 months, 1, 3, 5, 7, 10 years
Secondary record of adverse events intraop, 3/6 months, 1, 3, 5, 7, 10 years
Secondary implant stability trough assessment of presence of radiolucencies 3/6 months, 1, 3, 5, 7, 10 years
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