Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Joint Disease
• Intervention / Treatment: Device: total hip arthroplasty implant

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients previously implanted with DYNASTY® BioFoam® Acetabular Components

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Hip Arthroplasty; Single study group previously implanted with the following combination of components: MicroPort Orthopedics Femoral Stems, DYNASTY® BioFoam® Acetabular Components, DYNASTY® A-Class® Cross Linked Polyethylene Liners, and MicroPort Orthopedics Metal or Ceramic Femoral Heads	Device: total hip arthroplasty implant; Other Names: DYNASTY® BioFoam® Acetabular Components,; DYNASTY® A-Class® Cross Linked Polyethylene Liners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Paul Beaule, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimated): May 29, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; ankylosis; protrusio acetabuli; painful hip dysplasia; revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002C