OsteoarthritisPhase 4NCT00734084
A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee
A Phase 4 study testing Preservation Unicompartmental Knee in people with Osteoarthritis, run by DePuy International at 1 site in Australia.
Trial summary
The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Preservation Unicompartmental Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2001to Apr 2008
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, who are 40 to 75 years of age inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with a known history of poor compliance to medical treatment.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month.
- Subjects who are currently involved in any injury litigation claims.
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- Revision of an existing unicompartmental implant.
- Subjects who have gross ligament laxity / instability.
- Subjects who have an inflammatory joint disease
- Subjects in whom there is evidence of previous joint sepsis
- Subjects who have a pre-operative flexion contracture of 15° or greater
- Subjects who have a pre-operative flexion of less than 90°
- Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus
- Subjects who have morbid obesity i.e. BMI > 40%
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sportsmed SA, 32 Payneham, Stepney
Adelaide, South Australia, 5069
About this study
Official title: A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.
The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.
The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Read the detailed description
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.
Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.
- Conditions
- Osteoarthritis
- Being tested
- Preservation Unicompartmental Knee
- Keywords
- Arthroplasty, Knee, UKA, Partial, Preservation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservation Unicompartmental KneeDevice
Minimally invasive orthopaedic implant for single compartment knee arthritis
| Study group | Role | What they receive |
|---|---|---|
| Preservation Unicompartmental Knee | Other | Minimally invasive orthopaedic implant for single compartment knee arthritis Receives: Device: Preservation Unicompartmental Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
Intraoperative
Measured: 0 days
Secondary outcomes (1)
To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis.
Measured: 6 months, 1, 3, 5, 10 and 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startJun 2001
- Primary completionDec 2004
- Study completionApr 2008
Why it stopped: After a review of status, request of investigators \& since similar data was available from other sources
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Dwyer, Ph.D, Study chair, DePuy Synthes Joint Reconstruction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734084
- Sponsor's protocol ID
- CT 01/34
- Status last verified
- Jun 2015
- First submitted
- 11 Aug 2008
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.
- ClinicalTrials.gov ID
- NCT00734084
- Acronym / sponsor ID
- CT 01/34
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Knee, UKA, Partial, Preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After a review of status, request of investigators \& since similar data was available from other sources
- Enrolment
- 247 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Dec 2004 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Aug 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 primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.
The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Detailed description
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.
Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preservation Unicompartmental Knee | Other | Device: Preservation Unicompartmental KneeMinimally invasive orthopaedic implant for single compartment knee arthritis |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, who are 40 to 75 years of age inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Key exclusion criteria (14 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with a known history of poor compliance to medical treatment.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month.
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 |
|---|---|---|
| Preservation Unicompartmental KneeMinimally invasive orthopaedic implant for single compartment knee arthritis | Device | Preservation Unicompartmental Knee |
Primary outcome
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
Time frame: 0 days
Intraoperative
1 secondary outcome
To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis.
Time frame: 6 months, 1, 3, 5, 10 and 15 years
Results and safety
The study was stopped early (reason given: After a review of status, request of investigators \& since similar data was available from other sources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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.
Kim Dwyer, Ph.D study chair
DePuy Synthes Joint Reconstruction
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 Preservation Unicompartmental Knee in people with Osteoarthritis, run by DePuy International at 1 site in Australia.
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 14 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: stopped early, as of the sponsor's last update on 9 Jun 2015. 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 Australia. 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 was stopped early (reason given: After a review of status, request of investigators \& since similar data was available from other sources). Results are not available in the source record.
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?
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment (time frame: 0 days). 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 Jun 2015.