OsteoarthritisNCT00698152
A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 5 sites in United States.
Trial summary
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- How many people
- 149 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jan 2006to 15 Jan 2016
- 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: Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene
Who may be able to join
- Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of Functional Deformity
- Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
- Uncemented applications
Who cannot join
- Absolute contraindications
- Infection, sepsis and osteomyelitis
- Relative contraindications
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
Show all 10Show fewer
- Osteomalacia
- Distant foci of infections which may be spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Scranton Orthopaedic Specialists, PC
Dickson City, Pennsylvania, 18519
Texas Orthopedic Specialists, PA
Grapevine, Texas, 76051
The Orthopaedic Institute of Ohio
Lima, Ohio, 45804
The Orthopaedic Center
Rockville, Maryland, 20850
Ohio Valley Orthopedic and Sports Medicine
West Chester, Ohio, 45069
About this study
Official title: A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
Read the detailed description
Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected.
This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable.
The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Hip Arthritis, Polyethylene
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ArComXL® polyethylene | ArComXL® polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of revisions and removals
Patient questionnaire
Measured: Annually through 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study start23 Jan 2006
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 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
- NCT00698152
- Sponsor's protocol ID
- ORTHO.CR.H012
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2008
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00698152
- Acronym / sponsor ID
- ORTHO.CR.H012
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Hip Arthritis, Polyethylene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2006 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 17 Jun 2008 (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 data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
Detailed description
Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected.
This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable.
The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArComXL® polyethylene | – | –ArComXL® polyethylene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene
Key inclusion criteria (6 listed)
- Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of Functional Deformity
- Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
Key exclusion criteria (10 listed)
- Absolute contraindications
- Infection, sepsis and osteomyelitis
- Relative contraindications
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of revisions and removals
Time frame: Annually through 10 years
Patient questionnaire
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 30 Mar 2020.
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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
5 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 and Avascular Necrosis, run by Zimmer Biomet at 5 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 6 inclusion and 10 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Incidence of revisions and removals (time frame: Annually through 10 years). 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 30 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.