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

NCT02149667 | Active Not Recruiting

• 1 other identifier: 12-LJH-002C
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Disease

Keywords

osteoarthritis; avascular necrosis; ankylosis; protrusio acetabuli; painful hip dysplasia; rheumatoid arthritis; correction of functional deformity; revision procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient functional outcomes

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

Study Arms (1)

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

Interventions

total hip arthroplasty implant DEVICE

Also known as: DYNASTY® BioFoam® Acetabular Components,, DYNASTY® A-Class® Cross Linked Polyethylene Liners

Total Hip Arthroplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously implanted with DYNASTY® BioFoam® Acetabular Components

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis; Ankylosis; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Paul Beaule, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 29, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 7, 2023

Record last verified: 2023-04

Locations

CA (1)