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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Joint Disease Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROFEMUR® L Revision Femoral Stem

Device

Revision Total Hip Arthroplasty

Other names: Hip Revision Device

Primary outcomes

Number of participants who require a revision

Time frame: 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 outcomes

Patient functional score on the the Oxford Hip Score instrument

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2026
Study completion: 2027
First posted: Dec 11, 2014
Registry last updated: Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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