OsteoarthritisNCT00854295

Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

A study testing NexGen LPS-Flex Mobile Bearing Knee in people with Osteoarthritis and Traumatic Arthritis, run by Zimmer Biomet at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle
What is being tested?: NexGen LPS-Flex Mobile Bearing Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 3 sitesUnited States
Study dates: Apr 2009to Jun 2021
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Osteoarthritis
Primary and secondary traumatic arthritis
Avascular necrosis of the femoral condyle
Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)

Who cannot join

Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
A stable, painless arthrodesis in a satisfactory functional position

Show all 11Show fewer

Severe instability secondary to the absence of collateral integrity
Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.
Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up
Patient is not willing or able to give informed consent to participate in the follow-up program
Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Advanced Orthopaedics
Auburn Hills, Michigan, 48236-2776
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, 37923
Phoenix Clinical Research
Tamarac, Florida, 33321

Other trials in United States

About this study

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

Read the detailed description

The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery.

Conditions: Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus, Flexion Deformities
Being tested: NexGen LPS-Flex Mobile Bearing Knee
Keywords: arthritis, osteoarthritis, degenerative knee disease, avascular necrosis, total knee replacement, TKA
Medical subject headings: Osteoarthritis, Genu Valgum, Arthritis, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NexGen LPS-Flex Mobile Bearing KneeDevice
Also called Mobile bearing knee
Total Knee Replacement

Study groups in NCT00854295
Study group	Role	What they receive
Post-Approval Study Group (Group 2)	Experimental	Subjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years. Receives: Device: NexGen LPS-Flex Mobile Bearing Knee
Investigational Device Exemption Group (Group 1)	Experimental	Subjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years. Receives: Device: NexGen LPS-Flex Mobile Bearing Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

Group 2 - Total Knee Society Score (KSS)
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Measured: 5 year
Group 2 - Number of Subjects With Absence of Implant Revision
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Measured: 5 year
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.
Measured: 5 year
Group 1 - Total Knee Society Score (KSS)
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 4 year, 5 year, 6 year, 8 year, and 10 year
Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Measured: 10 year
Group 1 - Number of Subjects With Absence of Implant Revision
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Measured: 10 year
Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.
Measured: 10 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2021

First posted3 Mar 2009 (estimated)
Study startApr 2009
Primary completionJun 2020
Study completionJun 2021

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 OsteoarthritisStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00854295
Sponsor's protocol ID: 07-100
Status last verified: Jan 2023
First submitted: 26 Feb 2009
Last updated: 14 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
ClinicalTrials.gov ID: NCT00854295
Acronym / sponsor ID: 07-100
Conditions: Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus, Flexion Deformities
Keywords: arthritis, osteoarthritis, degenerative knee disease, avascular necrosis, total knee replacement, TKA
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Apr 2009 (actual)
Primary completion: Jun 2020 (actual)
Study completion: Jun 2021 (actual)
First posted: 3 Mar 2009 (estimated)
Results: Posted 14 Feb 2023

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 the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Post-Approval Study Group (Group 2)	Experimental	Device: NexGen LPS-Flex Mobile Bearing KneeSubjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years.
Investigational Device Exemption Group (Group 1)	Experimental	Device: NexGen LPS-Flex Mobile Bearing KneeSubjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Osteoarthritis
Primary and secondary traumatic arthritis
Avascular necrosis of the femoral condyle
Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)

Key exclusion criteria (11 listed)

Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb

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 Mobile Bearing KneeAlso: Mobile bearing kneeTotal Knee Replacement	Device	Investigational Device Exemption Group (Group 1), Post-Approval Study Group (Group 2)

Primary outcome

Group 2 - Total Knee Society Score (KSS)
Time frame: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
Time frame: 5 year
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Group 2 - Number of Subjects With Absence of Implant Revision
Time frame: 5 year
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
Time frame: 5 year
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.
Group 1 - Total Knee Society Score (KSS)
Time frame: 4 year, 5 year, 6 year, 8 year, and 10 year
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
Time frame: 10 year
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Group 1 - Number of Subjects With Absence of Implant Revision
Time frame: 10 year
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication
Time frame: 10 year
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.

Results and safety

Results posted to the registry on 14 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LPS Flex Mobile Unilateral Group (Group 2)	106	65
LPS Flex Mobile Bilateral Group (Group 2)	14	8
LPS Flex Fixed (Group 1)	77	54
LPS Flex Mobile (Group 1)	69	44

Primary outcome: Group 2 - Total Knee Society Score (KSS)

Time frame: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Mean (Standard Deviation). Unit: score on a scale

Measure	LPS Flex Mobile Unilateral Group (Group 2) n = 106	LPS Flex Mobile Bilateral Group (Group 2) n = 14
Pre-op	92.2 (28.5)	78.5 (29)
6 Week	118.2 (33)	96.7 (34)
6 Month	148 (29.7)	130.4 (51.5)
1 Year	159.2 (28.1)	137.2 (56.9)
2 Year	159.2 (32.2)	149.4 (34.7)
3 Year	161.1 (27.3)	147.3 (45.3)
4 Year	160.2 (29.4)	121.3 (56.7)
5 Year	160.8 (28.6)	167.1 (29.3)

Population analysed: Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.

Primary outcome: Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss

Time frame: 5 year. Count of participants. Unit: Participants

Measure	LPS Flex Mobile Unilateral Group (Group 2) n = 106	LPS Flex Mobile Bilateral Group (Group 2) n = 14
Value	90	14

Population analysed: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Primary outcome: Group 2 - Number of Subjects With Absence of Implant Revision

Time frame: 5 year. Count of participants. Unit: Participants

Measure	LPS Flex Mobile Unilateral Group (Group 2) n = 106	LPS Flex Mobile Bilateral Group (Group 2) n = 14
Value	103	14

Population analysed: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Primary outcome: Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication

Time frame: 5 year. Count of participants. Unit: Participants

Measure	LPS Flex Mobile Unilateral Group (Group 2) n = 106	LPS Flex Mobile Bilateral Group (Group 2) n = 14
Value	105	14

Population analysed: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Adverse events

Time frame: Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LPS Flex Mobile Unilateral (Group 2)	17 of 106 (16%)	82 of 106 (77.4%)	7 of 106
LPS Flex Mobile Bilateral (Group 2)	0 of 14 (0%)	14 of 14 (100%)	0 of 14
LPS Flex Fixed (Group 1)	8 of 77 (10.4%)	64 of 77 (83.1%)	1 of 77
LPS Flex Mobile (Group 1)	5 of 69 (7.2%)	14 of 69 (20.3%)	1 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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.

Erin Osborn study director

Zimmer Biomet

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NexGen LPS-Flex Mobile Bearing Knee in people with Osteoarthritis and Traumatic Arthritis, run by Zimmer Biomet at 3 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 4 inclusion and 11 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 14 Feb 2023). 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?

Group 2 - Total Knee Society Score (KSS) (time frame: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00854295.

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 14 Feb 2023.