ArCom® and ArComXL® Polyethylene Data Collection

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of Hip
• Intervention / Treatment: Device: ArCom® Polyethylene; Device: ArComXL® Polyethylene

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
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Ohio
    • New Albany, Ohio, United States, 43054
      • Joint Implant Surgeons, Inc.
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Center for Joint Replacement
  • Wisconsin
    • Oshkosh, Wisconsin, United States, 54904
      • The Kennedy Center for the Hip & Knee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients requiring total hip replacement.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ArCom® Polyethylene	Device: ArCom® Polyethylene; Argon packaged compression molded polyethylene
ArComXL® Polyethylene	Device: ArComXL® Polyethylene; Highly crosslinked Ultra High Molecular Weight Polyethylene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyethylene wear rates	Independent wear analysis of radiographs. The six-week radiographic evaluation will be assessed in comparison to the one-year evaluation in order to determine the early changes of the polyethylene. The difference between the one and two-year evaluations will yield the first true wear rate. We have included a three-year evaluation to reduce the scatter of the linear regression used to calculate the wear rate. The five-year and ten-year evaluations will produce mid and long-term wear rates.	6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Function, Absence of Deformity, and Range of Motion	Pain, Function, Absence of Deformity, and Range of Motion will be measured using the Harris Hip Score. On a scale of 0-100, higher scores mean a better outcome.	Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Physical Activity Level	Physical Activity Level will be measured using the UCLA Activity Scale. On a scale of 1-10, higher scores mean a better outcome.	Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.	Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Survivorship	Analyze survivorship using revision or intended revision as an endpoint.	Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Kacy Arnold, MBA, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): January 17, 2017
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: November 28, 2007
• First Submitted That Met QC Criteria: November 29, 2007
• First Posted (Estimated): November 30, 2007

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: ORTHO.CR.H011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No