Non-inflammatory Degenerative Joint DiseaseASRNCT00561600
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
A study testing ASR™-XL Modular Acetabular Cup System and Pinnacle™ acetabular shell in people with Non-inflammatory Degenerative Joint Disease, run by DePuy Orthopaedics at 8 sites in United States.
Trial summary
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease
- What is being tested?
- ASR™-XL Modular Acetabular Cup System and Pinnacle™ acetabular shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Nov 2006to 1 Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.
Who cannot join
- Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
- Subject with a known allergy to metal (e.g. jewelry).
- Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
- Subject has active or recent joint sepsis.
- Subject with marked atrophy or deformity in the upper femur.
- Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
Show all 11Show fewer
- Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
- Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
- Subject with known, active metastatic or neoplastic disease.
- Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
- Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Orthopaedic Specialists of Austin
Austin, Texas, 78705
Resurgens Orthopaedics
Cumming, Georgia, 30041
Spectrum Health Hospital Research
Grand Rapids, Michigan, 49503-2550
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053
Desert Orthopaedics
Rancho Mirage, California, 92270
Valley Orthopaedic Associates
Renton, Washington, 98055-5791
Eastern Oklahoma Orthopedic Center
Tulsa, Oklahoma, 74136
About this study
Official title: A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Read the detailed description
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
- Being tested
- ASR™-XL Modular Acetabular Cup System, Pinnacle™ acetabular shell
- Keywords
- Hip arthroplasty, Acetabular cup replacement, Acetabulum arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASR™-XL Modular Acetabular Cup SystemDevice
Also called Acetabular cup replacement
The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
Pinnacle™ acetabular shellDevice
Also called Acetabular cup replacement
The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | ASR™-XL Modular Acetabular Cup System stem Receives: Device: ASR™-XL Modular Acetabular Cup System |
| B | Active comparator | Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head. Receives: Device: Pinnacle™ acetabular shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"
Measured: 24-month interval.
Secondary outcomes (27)
T-Test of Harris Hip Total Score Means at 24 Months
T-Test of Harris Hip total score means at 24 months
Measured: 24 months
Harris Hip Pain Sub Score at 24 Months
Mean Harris Hip Pain sub score
Measured: 24 months
Harris Hip Function Score at 24 Months
Mean Harris Hip Function sub score at 24 months
Measured: 24 months
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: Pre-operative
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: pre-operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte cobalt
Measured: pre-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Measured: Pre-operative
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: 4 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: 4 months post operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Measured: 4 months post-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Measured: 4 months post-operative
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: 12 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: 12 Months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Measured: 12 Months
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Measured: 12 months
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: 24 months
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: 24 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Measured: 24 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Measured: 24 months
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: 36 months
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: 36 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte cobalt
Measured: 36 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte chromium
Measured: 36 months
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Measured: 48 months
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Measured: 48 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Measured: 48 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte chromium
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study start1 Nov 2006
- Primary completion1 Jan 2012
- Study completion1 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 265 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
- NCT00561600
- Sponsor's protocol ID
- 04062
- Acronym
- ASR
- Status last verified
- Jun 2017
- First submitted
- 20 Nov 2007
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study
- ClinicalTrials.gov ID
- NCT00561600
- Acronym / sponsor ID
- ASR / 04062
- Keywords
- Hip arthroplasty, Acetabular cup replacement, Acetabulum arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Detailed description
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: ASR™-XL Modular Acetabular Cup SystemASR™-XL Modular Acetabular Cup System stem |
| B | Active comparator | Device: Pinnacle™ acetabular shellPinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.
Key exclusion criteria (11 listed)
- Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
- Subject with a known allergy to metal (e.g. jewelry).
- Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
- Subject has active or recent joint sepsis.
- Subject with marked atrophy or deformity in the upper femur.
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 |
|---|---|---|
| ASR™-XL Modular Acetabular Cup SystemAlso: Acetabular cup replacementThe ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter. | Device | A |
| Pinnacle™ acetabular shellAlso: Acetabular cup replacementThe Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used. | Device | B |
Primary outcome
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
Time frame: 24-month interval.
"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"
27 secondary outcomes
T-Test of Harris Hip Total Score Means at 24 Months
Time frame: 24 months
Harris Hip Pain Sub Score at 24 Months
Time frame: 24 months
Harris Hip Function Score at 24 Months
Time frame: 24 months
Analysis of Metal Ion Release - Serum Cobalt
Time frame: Pre-operative
Analysis of Metal Ion Release - Serum Chromium
Time frame: pre-operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: pre-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: Pre-operative
Analysis of Metal Ion Release - Serum Cobalt
Time frame: 4 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Time frame: 4 months post operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: 4 months post-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: 4 months post-operative
Analysis of Metal Ion Release - Serum Cobalt
Time frame: 12 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Time frame: 12 Months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: 12 Months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: 12 months
Analysis of Metal Ion Release - Serum Cobalt
Time frame: 24 months
Analysis of Metal Ion Release - Serum Chromium
Time frame: 24 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: 24 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: 24 months
Analysis of Metal Ion Release - Serum Cobalt
Time frame: 36 months
Analysis of Metal Ion Release - Serum Chromium
Time frame: 36 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: 36 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: 36 months
Analysis of Metal Ion Release - Serum Cobalt
Time frame: 48 months
Analysis of Metal Ion Release - Serum Chromium
Time frame: 48 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time frame: 48 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASR™-XL Modular Acetabular Cup System and Pinnacle™ acetabular shell in people with Non-inflammatory Degenerative Joint Disease, run by DePuy Orthopaedics at 8 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 11 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes (time frame: 24-month interval.). 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 9 Aug 2017.