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NCT02314702Active, not recruiting

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Source: ClinicalTrials.gov · Last updated 13 Oct 2022

Brief summary (registry, in English)

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
26 (actual)
First submitted
3 Dec 2014
Start date
4 Sept 2015
Primary completion date
Oct 2026
Lead sponsor
MicroPort Orthopedics Inc.
NCT number
NCT02314702

What you commit to

  • Study type: Observational
  • Participants enrolled: 26
  • From 4 Sept 2015 to the primary completion date, Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Subjects currently enrolled in another clinical study
  • Subjects unwilling to sign the Informed Consent document
  • Subjects with substance abuse issues
  • Subjects who are incarcerated or have pending incarceration

Who the study is looking for

  • Has undergone revision total hip arthroplasty
  • Subject is implanted with the specified combination of components
  • Subject is willing and able to complete required study visits or assessments

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Cornwall Hospital
Coordinator of this site? Confirm its status
TruroUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.