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NCT02314702 Clinical Trial

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Joint Disease Clinical Trial

Official title:
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02314702
Other study ID # 12-LJH-002L
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 4, 2015
Est. completion date October 2027

Study information
Verified date October 2022
Source MicroPort Orthopedics Inc.
Contact n/a
Is FDA regulated No
Health authority
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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 26
Est. completion date October 2027
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Has undergone revision total hip arthroplasty - Subject is implanted with the specified combination of components - Subject is willing and able to complete required study visits or assessments Exclusion Criteria: - Subjects currently enrolled in another clinical study - Subjects unwilling to sign the Informed Consent document - Subjects with substance abuse issues - Subjects who are incarcerated or have pending incarceration

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PROFEMUR® L Revision Femoral Stem
Revision Total Hip Arthroplasty

Locations
Country Name City State
United Kingdom Royal Cornwall Hospital Truro Cornwall

Sponsors (1)
Lead Sponsor Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who require a revision The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up. 10 years post-operative
Secondary Patient functional score on the the Oxford Hip Score instrument To characterize patient hip-related health status, as assessed by Oxford Hip Scores Screening (First Available), 2-5 years, 5-7 years, and 10 years
Secondary Patient functional score on the EQ-5D-3L instrument To characterize patient general health status, as assessed by EQ-5D-3L scores Screening (First Available), 2-5 years, 5-7 years, and 10 years
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