OsteoarthritisNCT00306930
Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement
A study testing Acetabular cup in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 1 site in United States.
Trial summary
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Arthritis
- What is being tested?
- Acetabular cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,593 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- Primary hip replacement
- Sufficient bone stock to support implant
- Signed Informed Patient Consent form
Who cannot join
- Prior renal transplant
- History of active joint sepsis
- Recent high dose of corticosteroids
- Primary or secondary carcinoma in the last 5 years
- Neurological disease
- Psychosocial disease that would limit rehabilitation
- Use of structural bone graft
- Simultaneous participation in another hip study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.
Read the detailed description
The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.
- Being tested
- Acetabular cup
- Keywords
- Total Hip Replacement, post-traumatic arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetabular cupDevice
Also called Pinnacle™ Cup
Acetabular cup replacement
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Acetabular cup replacement with total hip arthroplasty Receives: Device: Acetabular cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Measured: 5 years
Secondary outcomes (3)
Harris Hip Score
Measured: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Short Form-36 (SF-36)
Measured: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startJul 2000
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Whalen, BS, DC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306930
- Sponsor's protocol ID
- PIN
- Status last verified
- Jul 2014
- First submitted
- 23 Mar 2006
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00306930
- Acronym / sponsor ID
- PIN
- Keywords
- Total Hip Replacement, post-traumatic arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,593 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Mar 2006 (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.
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.
Detailed description
The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Device: Acetabular cupAcetabular cup replacement with total hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary hip replacement
- Sufficient bone stock to support implant
- Signed Informed Patient Consent form
Key exclusion criteria (8 listed)
- Prior renal transplant
- History of active joint sepsis
- Recent high dose of corticosteroids
- Primary or secondary carcinoma in the last 5 years
- Neurological disease
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 |
|---|---|---|
| Acetabular cupAlso: Pinnacle™ CupAcetabular cup replacement | Device | A |
Primary outcome
Survivorship
Time frame: 5 years
3 secondary outcomes
Harris Hip Score
Time frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Short Form-36 (SF-36)
Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
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 29 Jul 2014.
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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.
Dave Whalen, BS, DC study director
DePuy Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetabular cup in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 1 site 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 3 inclusion and 8 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Survivorship (time frame: 5 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 29 Jul 2014.