ArCom® and ArComXL® Polyethylene Data Collection

NCT00565786 | Completed FDA Device

• 1 other identifier: ORTHO.CR.H011
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain, Function, Absence of Deformity, and Range of Motion

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

• Physical Activity Level

  Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

Other Outcomes (2)

• Adverse Event

  Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

• Survivorship

  Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year

Study Arms (2)

ArCom® Polyethylene

ArCom® Polyethylene

Device: ArCom® Polyethylene

ArComXL® Polyethylene

ArComXL® Polyethylene

Device: ArComXL® Polyethylene

Interventions

ArCom® Polyethylene DEVICE

Argon packaged compression molded polyethylene

ArCom® Polyethylene

ArComXL® Polyethylene DEVICE

Highly crosslinked Ultra High Molecular Weight Polyethylene

ArComXL® Polyethylene

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients requiring total hip replacement.

You may qualify if:

• 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

You may not qualify if:

• Infection
• Sepsis
• Osteomyelitis

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Joint Implant Surgeons, Inc.

New Albany, Ohio, 43054, United States

Location

Texas Center for Joint Replacement

Plano, Texas, 75093, United States

Location

The Kennedy Center for the Hip & Knee

Oshkosh, Wisconsin, 54904, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kacy Arnold, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: July 1, 2004
• Primary Completion: January 17, 2017
• Study Completion: January 13, 2020
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (3)