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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02149667
Other study ID # 12-LJH-002C
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
Study type Observational

Clinical Trial Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA 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:

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic 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 Active, not recruiting
Enrollment 48
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 THA for any of the following: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia - Inflammatory degenerative joint disease such as rheumatoid arthritis - 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: - Skeletally immature (less than 21 years of age at time of 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 have pending incarceration

Study Design


Related Conditions & MeSH terms


Intervention

Device:
total hip arthroplasty implant


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 component survivorship of all components out to 10 years follow-up. 10 years post-operative
Secondary Patient functional outcomes The secondary objective is to characterize total functional scores, as assessed by HOOS Scores and EQ-5D-3L Scores. Screening (First Available), 2-5 years, 5-7 years, and 10 years
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