ArCom® and ArComXL® Polyethylene Data Collection

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Zimmer Biomet ( Biomet Orthopedics, LLC )

ClinicalTrials.gov Identifier:

NCT00565786

First received: November 28, 2007

Last updated: August 1, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

August 1, 2016

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Polyethylene wear rates [ Time Frame: Duration of study ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00565786 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ArCom® and ArComXL® Polyethylene Data Collection

Official Title ^ICMJE

A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene

Brief Summary

The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.

Detailed Description

The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study population will include patients requiring total hip replacement.

Condition ^ICMJE

Osteoarthritis of Hip

Intervention ^ICMJE

Device: ArCom® Polyethylene
Argon packaged compression molded polyethylene
Device: ArComXL® Polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene

Study Groups/Cohorts

ArCom® Polyethylene
ArCom® Polyethylene

Intervention: Device: ArCom® Polyethylene
ArComXL® Polyethylene
ArComXL® Polyethylene

Intervention: Device: ArComXL® Polyethylene

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

150

Estimated Completion Date

March 2017

Estimated Primary Completion Date

November 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision of previously failed total hip arthroplasty

Exclusion Criteria:

Infection
Sepsis
Osteomyelitis

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00565786

Other Study ID Numbers ^ICMJE

ORTHO.CR.H011

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Biomet Orthopedics, LLC

Study Sponsor ^ICMJE

Biomet Orthopedics, LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Russell Schenck, PhD

Biomet Orthopedics, LLC

Information Provided By

Zimmer Biomet

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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