Total Knee ArthroplastyNCT00901329
NexGen Gender Fixed Bearing Knee Versus NexGen Legacy Knee Posterior Stabilized (LPS) - Flex Fixed Bearing Knee: A Study Comparing Two Different Knee Prostheses
A study testing NexGen Gender Fixed Bearing Knee prosthesis and NexGen LPS-Flex Fixed Bearing Knee prosthesis in people with Total Knee Arthroplasty, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- NexGen Gender Fixed Bearing Knee prosthesis and NexGen LPS-Flex Fixed Bearing Knee prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2007to Dec 2010
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients scheduled for simultaneous bilateral total knee arthroplasty (TKA) are included
- bilateral knee disease necessitating bilateral TKA
Who cannot join
- male sex
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
orthopedic department, section of arthroplasty, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: NEXGEN Gender Fixed Bearing Knee Versus NEXGEN LPS-Flex Fixed Bearing Knee - a Prospective Randomized Study Comparing Two Different Knee Prostheses
The purpose of this trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur (weight).
Read the detailed description
The present study compares the Gender prosthesis against the LPS-flex in a bilateral study, where patients are given two different prostheses: Gender on one side and LPS-flex on the other side. Patients are blinded to which prosthesis is selected for which side. The potential advantages of the Gender prosthesis include: less post-op pain due to better sizing (less overhang), less post-op patellofemoral pain and less compromised extensor mechanism and better patella tracking (due to less overstuffing of the patellofemoral joint).
Design:
The study is prospective, randomized, comparative and blinded. 24 female patients scheduled for simultaneous bilateral total knee arthroplasty are included (48 knees).
Power calculations cannot be performed as to how many patients are needed since no previous studies have been conducted.
All patients are included and operated by consultant Henrik Husted.
Methods:
Patients are randomized to which side is operated with which prosthesis (LPS-flex or Gender); the operations are performed using standard instrumentation and standard approaches.
At the operation the weight of the cut bone from the anterior femur is noted for each side. Before discharge radiographs including skyline views are performed to evaluate patella tracking (and are repeated at the final out-patient check 1 year post-op).
Gait analyses are performed before operation and 1 year post-op. All other procedures are standard procedures already implemented in the department.
Patients follow an accelerated track (ANORAK, 1,2) with an intended LOS of 4 days for bilaterally operated knee-arthroplasties, all patients are discharged directly to their homes.
- Conditions
- Total Knee Arthroplasty
- Being tested
- NexGen Gender Fixed Bearing Knee prosthesis, NexGen LPS-Flex Fixed Bearing Knee prosthesis
- Keywords
- TKA, functional outcome, pain, ROM, gait
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexGen Gender Fixed Bearing Knee prosthesisDevice
new female prosthesis
NexGen LPS-Flex Fixed Bearing Knee prosthesisDevice
standard knee prosthesis
| Study group | Role | What they receive |
|---|---|---|
| 1: Gender prosthesis | Experimental | Not described Receives: Device: NexGen Gender Fixed Bearing Knee prosthesis |
| 2: LPS flex prosthesis | Active comparator | Not described Receives: Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
follow-up at 6 weeks, 3 months, 6 months and one year. - knee-score and function score - feel of prosthesis (VAS 0-10) - ROM (max passive and active ROM is measured using a goniometer) - pain (VAS 0-10) - satisfaction (VAS 0-10)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901329
- Sponsor's protocol ID
- HD2007-0123
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEXGEN Gender Fixed Bearing Knee Versus NEXGEN LPS-Flex Fixed Bearing Knee - a Prospective Randomized Study Comparing Two Different Knee Prostheses
- ClinicalTrials.gov ID
- NCT00901329
- Acronym / sponsor ID
- HD2007-0123
- Conditions
- Total Knee Arthroplasty
- Keywords
- TKA, functional outcome, pain, ROM, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 May 2009 (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 trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur (weight).
Detailed description
The present study compares the Gender prosthesis against the LPS-flex in a bilateral study, where patients are given two different prostheses: Gender on one side and LPS-flex on the other side. Patients are blinded to which prosthesis is selected for which side. The potential advantages of the Gender prosthesis include: less post-op pain due to better sizing (less overhang), less post-op patellofemoral pain and less compromised extensor mechanism and better patella tracking (due to less overstuffing of the patellofemoral joint).
Design:
The study is prospective, randomized, comparative and blinded. 24 female patients scheduled for simultaneous bilateral total knee arthroplasty are included (48 knees).
Power calculations cannot be performed as to how many patients are needed since no previous studies have been conducted.
All patients are included and operated by consultant Henrik Husted.
Methods:
Patients are randomized to which side is operated with which prosthesis (LPS-flex or Gender); the operations are performed using standard instrumentation and standard approaches.
At the operation the weight of the cut bone from the anterior femur is noted for each side. Before discharge radiographs including skyline views are performed to evaluate patella tracking (and are repeated at the final out-patient check 1 year post-op).
Gait analyses are performed before operation and 1 year post-op. All other procedures are standard procedures already implemented in the department.
Patients follow an accelerated track (ANORAK, 1,2) with an intended LOS of 4 days for bilaterally operated knee-arthroplasties, all patients are discharged directly to their homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Gender prosthesis | Experimental | Device: NexGen Gender Fixed Bearing Knee prosthesis |
| 2: LPS flex prosthesis | Active comparator | Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female patients scheduled for simultaneous bilateral total knee arthroplasty (TKA) are included
- bilateral knee disease necessitating bilateral TKA
Key exclusion criteria (1 listed)
- male sex
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 |
|---|---|---|
| NexGen Gender Fixed Bearing Knee prosthesisnew female prosthesis | Device | 1: Gender prosthesis |
| NexGen LPS-Flex Fixed Bearing Knee prosthesisstandard knee prosthesis | Device | 2: LPS flex prosthesis |
Primary outcome
follow-up at 6 weeks, 3 months, 6 months and one year. - knee-score and function score - feel of prosthesis (VAS 0-10) - ROM (max passive and active ROM is measured using a goniometer) - pain (VAS 0-10) - satisfaction (VAS 0-10)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGen Gender Fixed Bearing Knee prosthesis and NexGen LPS-Flex Fixed Bearing Knee prosthesis in people with Total Knee Arthroplasty, run by Hvidovre University Hospital at 2 sites in Denmark.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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?
follow-up at 6 weeks, 3 months, 6 months and one year. - knee-score and function score - feel of prosthesis (VAS 0-10) - ROM (max passive and active ROM is measured using a goniometer) - pain (VAS 0-10) - satisfaction (VAS 0-10) (time frame: 1 year). 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 13 May 2009.