Joint Disease Clinical Trial
Official title:
Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components
Verified date | April 2023 |
Source | MicroPort Orthopedics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
MicroPort Orthopedics Inc. |
Canada,
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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