Trial record 4 of 9 for:    MPACT

Mpact Cup Performance After Total Hip Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Medacta International SA
Sponsor:
Information provided by (Responsible Party):
Medacta International SA
ClinicalTrials.gov Identifier:
NCT02846636
First received: July 22, 2016
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

Condition
Total Hip Replacement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty

Further study details as provided by Medacta International SA:

Primary Outcome Measures:
  • implant survival trough Kaplan-Meier curve [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hip function with Harris Hip Score [ Time Frame: preop, 3/6 months, 1, 3, 5, 7, 10 years ] [ Designated as safety issue: No ]
  • record of adverse events [ Time Frame: intraop, 3/6 months, 1, 3, 5, 7, 10 years ] [ Designated as safety issue: No ]
  • implant stability trough assessment of presence of radiolucencies [ Time Frame: 3/6 months, 1, 3, 5, 7, 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2014
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02846636

Contacts
Contact: Mara Colombo +41 91 696 60 60 colombo@medacta.ch

Locations
France
Clinique Médico-Chirurgicale Paris V Recruiting
Paris, France, 75007
Contact: Luc Kerboull    01 40 79 40 00      
Sponsors and Collaborators
Medacta International SA
  More Information

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT02846636     History of Changes
Other Study ID Numbers: P01.014.07 
Study First Received: July 22, 2016
Last Updated: July 27, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Commission nationale de l'informatique et des libertés

ClinicalTrials.gov processed this record on August 25, 2016