Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Joint Disease Clinical Trial

Official title:

Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02285842
• Other study ID #: 12-LJH-002F
• Status: Active, not recruiting
• Start date: December 2014
• Est. completion date: December 2028

Study information

• Verified date: April 2023
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing 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 components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 143
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Has undergone primary hip resurfacing 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 resurfacing 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:
• Primary hip resurfacing device
CONSERVE® Press-Fit Femoral Components

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Canada, 

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 HOOS and EQ-5D-3L scores	Screening (First Available), 2-5 years, 5-7 years, and 10 years
Secondary	Component alignment	To evaluate component alignment (neck shaft angle, stem shaft angle, and cup inclination) and the presence of radiolucencies surrounding implanted components	Screening (First Available), 2-5 years, 5-7 years, and 10 years