Osteoarthritis of HipNCT00565786
ArCom® and ArComXL® Polyethylene Data Collection
An observational study of Osteoarthritis of Hip, run by Zimmer Biomet at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of Hip
- What is being tested?
- ArCom® Polyethylene and ArComXL® Polyethylene
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to 13 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients requiring total hip replacement.
Who may be able to join
- 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
Who cannot join
- Infection
- Sepsis
- Osteomyelitis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Joint Implant Surgeons, Inc.
New Albany, Ohio, 43054
The Kennedy Center for the Hip & Knee
Oshkosh, Wisconsin, 54904
Texas Center for Joint Replacement
Plano, Texas, 75093
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis of Hip
- Being tested
- ArCom® Polyethylene, ArComXL® Polyethylene
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArCom® PolyethyleneDevice
Argon packaged compression molded polyethylene
ArComXL® PolyethyleneDevice
Highly crosslinked Ultra High Molecular Weight Polyethylene
| Study group | Role | What they receive |
|---|---|---|
| ArCom® Polyethylene | ArCom® Polyethylene Receives: Device: ArCom® Polyethylene | |
| ArComXL® Polyethylene | ArComXL® Polyethylene Receives: Device: ArComXL® Polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startJul 2004
- Primary completion17 Jan 2017
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565786
- Sponsor's protocol ID
- ORTHO.CR.H011
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2007
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene
- ClinicalTrials.gov ID
- NCT00565786
- Acronym / sponsor ID
- ORTHO.CR.H011
- Conditions
- Osteoarthritis of Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArCom® Polyethylene | – | Device: ArCom® PolyethyleneArCom® Polyethylene |
| ArComXL® Polyethylene | – | Device: ArComXL® PolyethyleneArComXL® Polyethylene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients requiring total hip replacement.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Infection
- Sepsis
- Osteomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArCom® PolyethyleneArgon packaged compression molded polyethylene | Device | ArCom® Polyethylene |
| ArComXL® PolyethyleneHighly crosslinked Ultra High Molecular Weight Polyethylene | Device | ArComXL® Polyethylene |
Primary outcome
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.
2 secondary outcomes
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
Physical Activity Level
Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kacy Arnold, MBA study director
Zimmer Biomet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of Hip, run by Zimmer Biomet at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyethylene wear rates (time frame: 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.