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Active, Not Recruiting

NCT Number: NCT02149667

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Joint Disease Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total hip arthroplasty implant

Device

Other names: DYNASTY® BioFoam® Acetabular Components,, DYNASTY® A-Class® Cross Linked Polyethylene Liners

Primary outcomes

  1. Component Survivorship

    Time frame: 10 years post-operative

    The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up.

Secondary outcomes

  1. Patient functional outcomes

    Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years

    The secondary objective is to characterize total functional scores, as assessed by HOOS Scores and EQ-5D-3L Scores.

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2028
First posted
May 29, 2014
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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