Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MicroPort Orthopedics Inc.
Study ID
NCT04147559
Status
Enrolling By Invitation

Conditions

  • Joint Diseases

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Hip Arthroplasty Implant — DEVICE
    Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.

Study Details

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.

Key Dates

Start date
Oct 21, 2020
Status verified
Mar 2024
Primary completion
May 1, 2033
Completion
Nov 1, 2033

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Component Survivorship [ Time Frame: 10 years post-operative ]

Locations (2)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
HCA Research Institute, OrthoONE at Swedish Medical CenterEnglewoodColorado80113-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute· Scottsdale, AZHCA Research Institute, OrthoONE at Swedish Medical Center· Englewood, CO

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