NCT00578851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

8.5 years

First QC Date

December 19, 2007

Last Update Submit

June 19, 2017

Conditions

OsteoarthritisAvascular NecrosisCongenital Hip DysplasiaTraumatic Arthritis

Keywords

Hip ArthroplastyHip Arthritis

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score, Radiographic Evaluation

    5 years

Secondary Outcomes (1)

  • Survivorship

    10 years

Study Arms (1)

C2a Taper recipients

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

Device: C2a - Taper™ Acetabular System

Interventions

C2a - Taper™ Acetabular SystemDEVICE

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

C2a Taper recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physician's Clinic of Iowa, PCI

Cedar Rapids, Iowa, 52401, United States

Location

Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisHip Dislocation, Congenital

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kara Mezger

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

April 1, 2006

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)