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Completed

NCT Number: NCT00565786

ArCom® and ArComXL® Polyethylene Data Collection

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.

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Key information

Conditions

Osteoarthritis of Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Implant Surgeons, Inc., New Albany, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ArCom® Polyethylene

Device

Argon packaged compression molded polyethylene

ArComXL® Polyethylene

Device

Highly crosslinked Ultra High Molecular Weight Polyethylene

Primary outcomes

  1. Polyethylene wear rates

    Time frame: 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

    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.

Secondary outcomes

  1. Pain, Function, Absence of Deformity, and Range of Motion

    Time frame: Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

    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.

  2. Physical Activity Level

    Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

    Physical Activity Level will be measured using the UCLA Activity Scale. On a scale of 1-10, higher scores mean a better outcome.

Other outcomes

  1. Adverse Event

    Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

    Evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.

  2. Survivorship

    Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

    Analyze survivorship using revision or intended revision as an endpoint.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2017
Study completion
2020
First posted
Nov 30, 2007
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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