Total Knee ArthroplastyNCT00763386
A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
A study testing NexGen LPS-Flex Fixed Bearing Knee and NexGen Legacy Posterior Stabilized Knee in people with Total Knee Arthroplasty and Osteoarthritis, run by Zimmer Biomet at 15 sites in 2 countries.
Trial summary
The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Osteoarthritis
- What is being tested?
- NexGen LPS-Flex Fixed Bearing Knee and NexGen Legacy Posterior Stabilized Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jun 2001to Mar 2010
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, 21-80 years
- Sex, Males and females will be included
- BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
- Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
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- Patient has stable and functional collateral ligaments.
- Patient has potential to perform higher than average range of motion activities.
- Operative side range of motion flexion greater than or equal to 90 degrees.
- Severe knee pain and disability due to degenerative joint disease.
- Patient or patient's legal representative has signed the Informed Consent form.
Who cannot join
- Previous history of infection in the affected joint.
- Previously failed knee endoprosthesis of any kind.
- Charcot joint disease or other severe neurosensory deficits.
- Previous patellectomy.
- Patient is skeletally immature.
- Grossly insufficient femoral or tibial bone stock.
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- Patient is pregnant.
- Varus or valgus deformity greater than 20 degrees.
- Fixed flexion deformity greater than 15 degrees.
- Previous high tibial osteotomy.
- Previous femoral osteotomy.
- Patient is a poor compliance risk - currently treated for ethanol or drug abuse, physical or mental handicap, etc.
- Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
VSAS Orthopaedics
Allentown, Pennsylvania, 18103
University of Alabama at Birmingham
Birmingham, Alabama, 35294
OrthoCarolina Research Institute
Charlotte, North Carolina, 28209
The Rectors and Visitors of the University of Virginia
Charlottesville, Virginia, 22908
VA Medical Center
Decatur, Georgia, 30033
Duke University Medical Center
Durham, North Carolina, 27710
Rebecca Sealy Hospital
Galveston, Texas, 77555
Piedmont Orthopaedic Associates
Greenville, South Carolina, 29615
Joint Replacement Surgeons of Indiana
Indianapolis, Indiana, 46260
The Center for Hip and Knee Surgery
Mooresville, Indiana, 46158
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Orthopaedic Specialists of Spartanburg
Spartanburg, South Carolina, 29303
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
About this study
Official title: Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.
Read the detailed description
This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Being tested
- NexGen LPS-Flex Fixed Bearing Knee, NexGen Legacy Posterior Stabilized Knee
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexGen LPS-Flex Fixed Bearing KneeDevice
Also called LPS-Flex Knee
NexGen LPS-Flex Fixed Bearing femoral component
NexGen Legacy Posterior Stabilized KneeDevice
Also called LPS Knee
NexGen Legacy Posterior Stabilized femoral component
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. Receives: Device: NexGen LPS-Flex Fixed Bearing Knee |
| 2 | Active comparator | Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. Receives: Device: NexGen Legacy Posterior Stabilized Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Range of Motion (ROM)
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
Measured: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Secondary outcomes (1)
Return to Function (RtF) Via Knee Society Score (Modified)
Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.
Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Measured: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJun 2001
- Primary completionDec 2009
- Study completionMar 2010
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 Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763386
- Sponsor's protocol ID
- 00-500
- Status last verified
- May 2012
- First submitted
- 26 Sep 2008
- Last updated
- 4 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
- ClinicalTrials.gov ID
- NCT00763386
- Acronym / sponsor ID
- 00-500
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 25 May 2012
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 test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.
Detailed description
This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: NexGen LPS-Flex Fixed Bearing KneeStudy arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. |
| 2 | Active comparator | Device: NexGen Legacy Posterior Stabilized KneeStudy arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age, 21-80 years
- Sex, Males and females will be included
- BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
Key exclusion criteria (13 listed)
- Previous history of infection in the affected joint.
- Previously failed knee endoprosthesis of any kind.
- Charcot joint disease or other severe neurosensory deficits.
- Previous patellectomy.
- Patient is skeletally immature.
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 LPS-Flex Fixed Bearing KneeAlso: LPS-Flex KneeNexGen LPS-Flex Fixed Bearing femoral component | Device | 1 |
| NexGen Legacy Posterior Stabilized KneeAlso: LPS KneeNexGen Legacy Posterior Stabilized femoral component | Device | 2 |
Primary outcome
Postoperative Range of Motion (ROM)
Time frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
1 secondary outcome
Return to Function (RtF) Via Knee Society Score (Modified)
Time frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGen LPS-Flex Fixed Bearing Knee and NexGen Legacy Posterior Stabilized Knee in people with Total Knee Arthroplasty and Osteoarthritis, run by Zimmer Biomet at 15 sites in 2 countries.
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 11 inclusion and 13 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, 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?
Yes. Results are posted in the registry (first posted 25 May 2012). 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?
Postoperative Range of Motion (ROM) (time frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed). 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 4 Jun 2012.