A Clinical Investigation of the C2a-Taper™ Acetabular System

Zimmer Biomet

Status: Completed

Conditions: Traumatic Arthritis; Osteoarthritis; Congenital Hip Dysplasia; Avascular Necrosis

Treatments: Device: C2a - Taper™ Acetabular System

Study type: Observational

Funder types: Industry

Identifiers

NCT00578851

P050009 (Other Identifier)

ORTHO.CR.H021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

C2a Taper recipients

Description:

Patients who receive a THA with the C2a - Taper™ Acetabular System

Treatment:

Device: C2a - Taper™ Acetabular System