PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

Joint Disease Clinical Trial

Official title:

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02507258
• Other study ID #: 12-LJH-002K
• Status: Withdrawn
• Start date: December 2017
• Est. completion date: December 2028

Study information

• Verified date: June 2018
• 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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Subject 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 skeletally immature (less than 21 years of age) at time of primary THA surgery

• Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA

• 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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component

Locations

Country	Name	City	State
France	Hopital Joseph Ducuing	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Component Survivorship	The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.	10 years post-operative
Secondary	Patient functional outcomes (hip specific)	To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores	Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval