Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems

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) European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.

Study Overview

• Status: Terminated
• Conditions: Joint Disease
• Intervention / Treatment: Device: total hip arthroplasty implant

Detailed Description

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously implanted with PROFEMUR® Gladiator femoral stems

Description

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

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) 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 have pending incarceration

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Hip Arthroplasty; Single group previously implanted with the following combination of components: PROFEMUR® Gladiator femoral stem, MicroPort acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.	Device: total hip arthroplasty implant; Other Names: PROFEMUR Gladiator femoral stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component Survivorship	The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient functional outcomes	To characterize total functional scores, as assessed by Oxford Hip Scores and EQ-5D-3L scores	Screening (First Available), 2-5 years, 5-7 years, and 10 years

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; ankylosis; protrusio acetabuli; revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002J