OsteoarthritisNCT00351793
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
An observational study of Osteoarthritis, run by Ross Leighton at 1 site in Canada.
Trial summary
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Knee Implant
- Type of treatment
- Medical device
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2003to Jul 2021
- 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: Total knee replacement candidates
Who may be able to join
- A combined deformity of <30 degrees = group 1
- A combined deformity of >30 degrees = group 2
- Patient is willing to consent to participate in the study
- Patient is available for follow-up through at least 2 years but preferably 5 years
- Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
- Patients who are fluent in English and are able to understand their role in a clinical trial
Who cannot join
- Active, local infection or systemic infection
- Fibromyalgia patients
- Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.
- Conditions
- Osteoarthritis
- Being tested
- Knee Implant
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee ImplantDevice
Total knee replacement with Genesis II posterior stabilized knee
| Study group | Role | What they receive |
|---|---|---|
| Combined Deformity <30 degrees | Not described Receives: Device: Knee Implant | |
| Combined Deformity >30 degrees | Not described Receives: Device: Knee Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and Safety
Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation
Measured: 5 years
Secondary outcomes (2)
Knee Society Clinical Rating
Measured: Pre-op, 6 months, 1 year, 2 years, 5 years
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
Measured: Pre-op, 6 months, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJan 2003
- Primary completionDec 2018
- Study completionJul 2021
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ross Leighton
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Ross Leighton, Nova Scotia Health Authority
- Investigators
- Ross K Leighton, MD, FRCS(C), Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351793
- Sponsor's protocol ID
- CDHA-RL-004
- Status last verified
- Nov 2022
- First submitted
- 12 Jul 2006
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00351793
- Acronym / sponsor ID
- CDHA-RL-004
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Ross LeightonUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- Jan 2003
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 13 Jul 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.
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Deformity <30 degrees | – | Device: Knee Implant |
| Combined Deformity >30 degrees | – | Device: Knee Implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Total knee replacement candidates
Key inclusion criteria (6 listed)
- A combined deformity of <30 degrees = group 1
- A combined deformity of >30 degrees = group 2
- Patient is willing to consent to participate in the study
- Patient is available for follow-up through at least 2 years but preferably 5 years
- Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
Key exclusion criteria (3 listed)
- Active, local infection or systemic infection
- Fibromyalgia patients
- Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
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 |
|---|---|---|
| Knee ImplantTotal knee replacement with Genesis II posterior stabilized knee | Device | Combined Deformity <30 degrees, Combined Deformity >30 degrees |
Primary outcome
Effectiveness and Safety
Time frame: 5 years
Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation
2 secondary outcomes
Knee Society Clinical Rating
Time frame: Pre-op, 6 months, 1 year, 2 years, 5 years
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Pre-op, 6 months, 1 year, 2 years, 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 9 Nov 2022.
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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?
An observational study of Osteoarthritis, run by Ross Leighton 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 6 inclusion and 3 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 Nov 2022. 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.
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?
Effectiveness and Safety (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 9 Nov 2022.