ArCom® and ArComXL® Polyethylene Data Collection

Osteoarthritis of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565786
• Other study ID #: ORTHO.CR.H011
• Status: Completed
• Start date: July 2004
• Est. completion date: January 13, 2020

Study information

• Verified date: March 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 13, 2020
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis of Hip
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
United States	Joint Implant Surgeons, Inc.	New Albany	Ohio
United States	The Kennedy Center for the Hip & Knee	Oshkosh	Wisconsin
United States	Texas Center for Joint Replacement	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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