Knee OsteoarthritisPhase 2NCT00743717
Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement
A Phase 2 study testing zirconia femoral component and cobalt chrome femoral component in people with Knee Osteoarthritis, run by Kinamed Incorporated.
Trial summary
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- zirconia femoral component and cobalt chrome femoral component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2012
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Skeletally mature
- Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
- Stable or reconstructable collateral and posterior cruciate ligaments
- Correctable deformity
- Intact quadriceps and hamstrings mechanisms
- Patella bone thick enough (at least 15 mm) after resection
Who cannot join
- Previous TKA
- Bilateral knee arthritis
- Non-availability for follow-up
- Mental incompetence or confinement
- Patients being treated with other investigational devices for same disorder
- Infection
Show all 14Show fewer
- Osteoporosis, acute renal failure, or other disorders known to affect bone quality
- Charcot's or Paget's disease
- Patient physical condition preventing use of appropriate size implant
- Disease conditions affecting blood supply to knee
- Insufficient bone quality or quantity
- Physical condition predisposing implant to extreme loads
- History of septic knee arthritis
- History of drug abuse
About this study
Official title: Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.
Read the detailed description
Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.
- Conditions
- Knee Osteoarthritis
- Being tested
- zirconia femoral component, cobalt chrome femoral component
- Keywords
- total knee arthroplasty, osteoarthritis, ceramic bearing, zirconia
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconia femoral componentDevice
total knee arthroplasty performed using implant with zirconia femoral component
cobalt chrome femoral componentDevice
total knee arthroplasty performed using implant with cobalt chrome femoral component
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: zirconia femoral component |
| 2 | Active comparator | Not described Receives: Device: cobalt chrome femoral component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Score at 2 Years Post Operation
The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess "success".
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2012
- Study completionDec 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 Knee 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinamed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vineet Sarin, PhD, Study director, Kinamed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743717
- Sponsor's protocol ID
- G010204
- Status last verified
- May 2013
- First submitted
- 27 Aug 2008
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
- ClinicalTrials.gov ID
- NCT00743717
- Acronym / sponsor ID
- G010204
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, osteoarthritis, ceramic bearing, zirconia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Kinamed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Posted 22 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.
Detailed description
Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: zirconia femoral component |
| 2 | Active comparator | Device: cobalt chrome femoral component |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Skeletally mature
- Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
- Stable or reconstructable collateral and posterior cruciate ligaments
- Correctable deformity
- Intact quadriceps and hamstrings mechanisms
Key exclusion criteria (14 listed)
- Previous TKA
- Bilateral knee arthritis
- Non-availability for follow-up
- Mental incompetence or confinement
- Patients being treated with other investigational devices for same disorder
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 |
|---|---|---|
| zirconia femoral componenttotal knee arthroplasty performed using implant with zirconia femoral component | Device | 1 |
| cobalt chrome femoral componenttotal knee arthroplasty performed using implant with cobalt chrome femoral component | Device | 2 |
Primary outcome
Knee Score at 2 Years Post Operation
Time frame: within 2 years
The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess "success".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- 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.
Vineet Sarin, PhD study director
Kinamed Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zirconia femoral component and cobalt chrome femoral component in people with Knee Osteoarthritis, run by Kinamed Incorporated.
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 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: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2013). 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?
Knee Score at 2 Years Post Operation (time frame: within 2 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 27 May 2013.