ArCom® and ArComXL® Polyethylene Data Collection

Tracking Information
First Submitted Date	November 28, 2007
First Posted Date	November 30, 2007
Last Update Posted Date	August 2, 2016
Study Start Date	July 2004
Estimated Primary Completion Date	November 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 29, 2007)	Polyethylene wear rates [ Time Frame: Duration of study ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00565786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 29, 2007)	Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	ArCom® and ArComXL® Polyethylene Data Collection
Official Title	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	Observational
Study Design	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	Osteoarthritis of Hip
Intervention	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	Active, not recruiting
Actual Enrollment; (submitted: November 29, 2007)	150
Original Actual Enrollment	Same as current
Estimated Study Completion Date	March 2017
Estimated Primary Completion Date	November 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria	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	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00565786
Other Study ID Numbers	ORTHO.CR.H011
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Zimmer Biomet ( Biomet Orthopedics, LLC )
Study Sponsor	Biomet Orthopedics, LLC
Collaborators	Not Provided
Investigators	Principal Investigator: Russell Schenck, PhD Biomet Orthopedics, LLC
PRS Account	Zimmer Biomet
Verification Date	July 2016