Total Knee ArthroplastyNCT00761956
A Study to Compare the NexGen CR and CR-Flex Knee Implants
A study testing NexGen CR-Flex Fixed Bearing Knee and NexGen CR Knee in people with Total Knee Arthroplasty and Osteoarthritis, run by Zimmer Biomet at 8 sites in United States.
Trial summary
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-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 CR-Flex Fixed Bearing Knee and NexGen CR Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2004to Dec 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, Male and Females will be included
- BMI less than or equal to 39
- Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
- Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
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- Patient has stable and functional posterior cruciate and 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 120 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Chicago Hospital
Chicago, Illinois, 60637
The Orthopedic Group
Clairton, Pennsylvania, 15025
Slocum Orthopedics, PC
Eugene, Oregon, 97401
Orthopaedic Associates of Grand Rapids, PC
Grand Rapids, Michigan, 49525
Dickinson Medical Group, LLC
Milford, Delaware, 19963
Pinehurst Surgical Center
Pinehurst, North Carolina, 28374
Rockford Orthopedic Associates
Rockford, Illinois, 61107
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
Read the detailed description
This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative 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 CR-Flex Fixed Bearing Knee, NexGen CR 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 CR-Flex Fixed Bearing KneeDevice
Also called CR-Flex Knee
NexGen CR-Flex Fixed Bearing femoral component
NexGen CR KneeDevice
Also called CR Knee
NexGen Complete Knee Solution Cruciate Retaining femoral component
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. Receives: Device: NexGen CR-Flex Fixed Bearing Knee |
| 2 | Active comparator | Study arm will consist of patients that are treated with the NexGen CR Knee. Receives: Device: NexGen CR Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Range of Motion (ROM)
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
Measured: 24 Months
Secondary outcomes (1)
Return to Function (RtF) Via Knee Scoiety 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 estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Measured: 24 Months
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 startSep 2004
- Primary completionDec 2010
- Study completionDec 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
- 189 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
- NCT00761956
- Sponsor's protocol ID
- 04-300
- Status last verified
- Jun 2012
- First submitted
- 26 Sep 2008
- Last updated
- 16 Jul 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 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
- ClinicalTrials.gov ID
- NCT00761956
- Acronym / sponsor ID
- 04-300
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 16 Jul 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, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
Detailed description
This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative 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 CR-Flex Fixed Bearing KneeStudy arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. |
| 2 | Active comparator | Device: NexGen CR KneeStudy arm will consist of patients that are treated with the NexGen CR 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, Male and Females will be included
- BMI less than or equal to 39
- Stable Health, the patient would be able to undergo surgery and participate in a 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 CR-Flex Fixed Bearing KneeAlso: CR-Flex KneeNexGen CR-Flex Fixed Bearing femoral component | Device | 1 |
| NexGen CR KneeAlso: CR KneeNexGen Complete Knee Solution Cruciate Retaining femoral component | Device | 2 |
Primary outcome
Postoperative Range of Motion (ROM)
Time frame: 24 Months
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
1 secondary outcome
Return to Function (RtF) Via Knee Scoiety Score (Modified)
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGen CR-Flex Fixed Bearing Knee and NexGen CR Knee in people with Total Knee Arthroplasty and Osteoarthritis, run by Zimmer Biomet at 8 sites in United States.
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 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 16 Jul 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: 24 Months). 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 16 Jul 2012.