CoMplete™ Acetabular Hip System

NCT ID: NCT01543230

Last Updated: 2014-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-inflammatory Degenerative Joint Disease Osteoarthritis Post-traumatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CoMplete™ Acetabular Hip System (CoM)

Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Group Type EXPERIMENTAL

Total hip replacement

Intervention Type DEVICE

Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total hip replacement

Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\. If the subject:

1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
2. Qualifies based on the approved labeling for the device; and
* 2\. Is willing and able to provide informed patient consent for participation in the PAS study; and
* 3\. Is willing and able to return for follow-up as specified by the PAS study protocol; and
* 4\. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

* consented to participate,
* authorized release of Personal Health Information (PHI),
* met all eligibility criteria through the operative stage, and
* received the implant as noted in this protocol.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dave Whalen, BS, DC

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hip and Knee Arkansas Foundation

Little Rock, Arkansas, United States

Site Status

Orthopaedic Specialty Institute

Orange, California, United States

Site Status

Fort Collins, Colorado, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.