A Clinical Investigation of the C2a-Taper™ Acetabular System

• Sponsor: Biomet Orthopedics, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00578851
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Duration (Months): 114
• Patients Per Site: 14
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis	Device: C2a - Taper™ Acetabular System

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Approval Study of the C2a-Taper™ Acetabular System
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
C2a Taper recipients Patients who receive a THA with the C2a - Taper™ Acetabular System	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.

Outcome Measures

Primary Outcome Measures

1. Harris Hip Score, Radiographic Evaluation [5 years]

Secondary Outcome Measures

1. Survivorship [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physician's Clinic of Iowa, PCI	Cedar Rapids	Iowa	United States	52401
2	Lexington Clinic	Lexington	Kentucky	United States	40504

Sponsors and Collaborators

• Biomet Orthopedics, LLC

Investigators

• Study Director: Kara Mezger, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biomet Orthopedics, LLC
• ClinicalTrials.gov Identifier: NCT00578851
• Other Study ID Numbers: ORTHO.CR.H021; P050009
• First Posted: Dec 21, 2007
• Last Update Posted: Jun 21, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Biomet Orthopedics, LLC: Hip Arthroplasty; Hip Arthritis
• Additional relevant MeSH terms: Arthritis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis

Study Results

No Results Posted as of Jun 21, 2017