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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02314702

Enrollment

Registered

2014-12-11

Start date

2015-09-04

Completion date

2027-10-31

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Disease

Keywords

Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity, Revision procedures

Brief summary

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.

Interventions

DEVICEPROFEMUR® L Revision Femoral Stem

Revision Total Hip Arthroplasty

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who require a revision	10 years post-operative	The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.

Secondary

Measure	Time frame	Description
Patient functional score on the the Oxford Hip Score instrument	Screening (First Available), 2-5 years, 5-7 years, and 10 years	To characterize patient hip-related health status, as assessed by Oxford Hip Scores
Patient functional score on the EQ-5D-3L instrument	Screening (First Available), 2-5 years, 5-7 years, and 10 years	To characterize patient general health status, as assessed by EQ-5D-3L scores

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026