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Active, Not Recruiting

NCT Number: NCT02823834

PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

Elbe Kliniken Buxtehude

Buxtehude, 21614, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has undergone primary THA for any of the following:
  • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
  • Inflammatory degenerative joint disease such as rheumatoid arthritis; or
  • Correction of functional deformity
  • Subject is implanted with the specified combination of components
  • Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs enrolled in the study provided:

  • the specified combination of components were implanted in both
  • all other aspects of the Inclusion/Exclusion Criteria are satisfied
  • enrollment does not exceed the subject count specified in the Clinical Trial Agreement
  • the subject agrees to a second Informed Consent document specific to the second THA.

Exclusion criteria

  • Subjects implanted with a metal-on-metal articulation
  • Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
  • Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
  • Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
  • Subjects unwilling to sign the Informed Consent document
  • Subjects with substance abuse issues
  • Subjects who are incarcerated or having pending incarceration

Treatment and study plan

PROFEMUR® Gladiator Plasma Femoral Stems

Device

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Other names: Primary hip replacement device

Primary outcomes

  1. Component Survivorship

    Time frame: 10 years post-operative

    The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.

Secondary outcomes

  1. Patient functional outcomes (hip specific)

    Time frame: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit

    To characterize total functional scores, as assessed by Oxford Hip Scores

  2. Patient functional outcomes (quality of life)

    Time frame: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit

    To characterize total functional scores, as assessed by EQ-5D-3L scores

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Official study title

Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2016
Registry last updated
Jul 8, 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.

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