A Clinical Investigation of the C2a-Taper™ Acetabular System

Osteoarthritis Clinical Trial

Official title:

Post Approval Study of the C2a-Taper™ Acetabular System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578851
• Other study ID #: ORTHO.CR.H021
• Secondary ID: P050009
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: June 19, 2017
• Start date: April 2006
• Est. completion date: October 2015

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Traumatic Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Physician's Clinic of Iowa, PCI	Cedar Rapids	Iowa
United States	Lexington Clinic	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score, Radiographic Evaluation		5 years
Secondary	Survivorship		10 years