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Completed

NCT Number: NCT00578851

A Clinical Investigation of the C2a-Taper™ Acetabular System

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

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Key information

Conditions

Osteoarthritis Arthritis Avascular Necrosis Bone Diseases Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Hip Dislocation, Congenital Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Traumatic Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physician's Clinic of Iowa, PCI, Cedar Rapids, Iowa, United States

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About this study

Study Design:

Phase 1

Sites will collect the following types of data:

Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events

Follow-up Visit schedule

  • 6 week ± 2 weeks
  • 6 month ± 1 month
  • 1 year ± 3 months
  • 2 years ± 3 months
  • 3 years ± 3 months
  • 4 years ± 3 months
  • 5 years ± 3 months

Phase 2:

Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion criteria

  • Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease

Treatment and study plan

C2a - Taper™ Acetabular System

Device

The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.

Primary outcomes

  1. Harris Hip Score, Radiographic Evaluation

    Time frame: 5 years

Secondary outcomes

  1. Survivorship

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Biomet Orthopedics, LLC

Industry

Registry information

Official study title

Post Approval Study of the C2a-Taper™ Acetabular System

Important dates

Study start
2006
Primary completion
2014
Study completion
2015
First posted
Dec 21, 2007
Registry last updated
Jun 21, 2017

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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