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

Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02397746
• Other study ID #: 12-LJH-002J
• Status: Terminated
• Start date: July 2015
• Est. completion date: December 20, 2021

Study information

• Verified date: December 2022
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• total hip arthroplasty implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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