OsteoarthritisPhase 4NCT00689689
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
A Phase 4 study testing Fully coated Prodigy stem and Cemented Endurance Stem in people with Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality. Read more about this study
- Who is it for?
- Ages 72 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fully coated Prodigy stem and Cemented Endurance Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jul 1998to Nov 2009
- Phase
- Phase 4
- 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 72 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
- Revisions of failed osteotomies may be included
- Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients > 72 years of age
Who cannot join
- Patients with active infection
- Revision cemented total hip replacement
- Charcot joints
- Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
- C.D.H. with abnormally placed acetabuli or femoral canals
- Fibromyalgia patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.
- Conditions
- Osteoarthritis
- Being tested
- Fully coated Prodigy stem, Cemented Endurance Stem
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully coated Prodigy stemDevice
Total hip arthroplasty with fully coated Prodigy stem
Cemented Endurance StemDevice
total hip arthroplasty with cemented endurance stem
| Study group | Role | What they receive |
|---|---|---|
| Fully Coated Prodigy Stem (AML) | Active comparator | Total hip arthroplasty with fully coated prodigy stem (AML) Receives: Device: Fully coated Prodigy stem |
| Cemented Endurance Hip Stem | Active comparator | Total hip arthroplasty with cemented Endurance hip stem component Receives: Device: Cemented Endurance Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision
Secondary outcomes (2)
Womac
SF-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJul 1998
- Primary completionNov 2009
- Study completionNov 2009
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 Nova Scotia Health AuthorityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross K Leighton, MD, FRCS(C), Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689689
- Sponsor's protocol ID
- CDHA-RL-005
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
- ClinicalTrials.gov ID
- NCT00689689
- Acronym / sponsor ID
- CDHA-RL-005
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 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 study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully Coated Prodigy Stem (AML) | Active comparator | Device: Fully coated Prodigy stemTotal hip arthroplasty with fully coated prodigy stem (AML) |
| Cemented Endurance Hip Stem | Active comparator | Device: Cemented Endurance StemTotal hip arthroplasty with cemented Endurance hip stem component |
Who may qualify
- Ages
- 72 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
- Revisions of failed osteotomies may be included
- Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients > 72 years of age
Key exclusion criteria (6 listed)
- Patients with active infection
- Revision cemented total hip replacement
- Charcot joints
- Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
- C.D.H. with abnormally placed acetabuli or femoral canals
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 |
|---|---|---|
| Fully coated Prodigy stemTotal hip arthroplasty with fully coated Prodigy stem | Device | Fully Coated Prodigy Stem (AML) |
| Cemented Endurance Stemtotal hip arthroplasty with cemented endurance stem | Device | Cemented Endurance Hip Stem |
Primary outcome
Revision
2 secondary outcomes
Womac
SF-12
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 16 Feb 2012.
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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.
Ross K Leighton, MD, FRCS(C) principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fully coated Prodigy stem and Cemented Endurance Stem in people with Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
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 6 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 16 Feb 2012. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Revision. 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 16 Feb 2012.