OsteoarthritisNCT03272373
NexGen TM Tibia Clinical Outcomes Study
A study testing NexGen TM Monoblock Tibia and NexGen TM Modular Tibia in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 7 sites in United States.
Trial summary
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- What is being tested?
- NexGen TM Monoblock Tibia and NexGen TM Modular Tibia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Oct 2017to 31 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age.
- Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
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- The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- Patient has participated in the study-related Informed Consent process.
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
- Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.
Who cannot join
- Previous history of infection in the affected joint.
- Active local or 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.
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- A stable, painless arthrodesis in a satisfactory functional position.
- Severe instability secondary to the absence of collateral ligament integrity.
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
- Patient is currently participating in any other surgical intervention studies or pain management studies.
- Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Woods Mill Orthopedics, Ltd
Chesterfield, Missouri, 63017
Franciscan Health
Mooresville, Indiana, 46158
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, 47362
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
LA BioMed at Harbor-UCLA Medical Center
Torrance, California, 90502
Cornerstone Orthopaedics & Sports Medicine, P.C.
Wheat Ridge, Colorado, 80033
About this study
Official title: NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
Read the detailed description
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.
The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.
The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.
The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:
- No revisions for any reason
- Oxford Knee Score >38
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle, Post-traumatic Loss of Joint Configuration
- Being tested
- NexGen TM Monoblock Tibia, NexGen TM Modular Tibia
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexGen TM Monoblock TibiaDevice
Primary cementless tibia total knee arthroplasty
NexGen TM Modular TibiaDevice
Primary cementless tibia total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Monoblock | Other | Subjects that receive the NexGen TM Monoblock Tibia Receives: Device: NexGen TM Monoblock Tibia |
| Modular | Other | Subjects that receive the NexGen TM Modular Tibia Receives: Device: NexGen TM Modular Tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiograph Assessment of Progressive Tibial Radiolucencies
Progressive tibial radiolucency will be derived in accordance with the following definitions:
Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone.
Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of >0.5mm.
Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.
Measured: 2 years
Secondary outcomes (2)
Oxford Knee Score
The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The maximum score is 48 points (best) and the minimum score is 0 points (worst).
Measured: 2 years
Revision Rate
Rate of the number of revisions for any reason
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start3 Oct 2017
- Primary completion30 Mar 2023
- Study completion31 Mar 2023
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
- Parallel groups
- Model description
- 2 single arms being analyzed separately
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, RN, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272373
- Sponsor's protocol ID
- K.CR.I.G.16.34
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2017
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
- ClinicalTrials.gov ID
- NCT03272373
- Acronym / sponsor ID
- K.CR.I.G.16.34
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle, Post-traumatic Loss of Joint Configuration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
Detailed description
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.
The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.
The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.
The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:
- No revisions for any reason
- Oxford Knee Score >38
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 single arms being analyzed separately
| Arm | Type | Receives |
|---|---|---|
| Monoblock | Other | Device: NexGen TM Monoblock TibiaSubjects that receive the NexGen TM Monoblock Tibia |
| Modular | Other | Device: NexGen TM Modular TibiaSubjects that receive the NexGen TM Modular Tibia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is at least 18 years of age.
- Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Patient has participated in the study-related Informed Consent process.
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
Key exclusion criteria (13 listed)
- Previous history of infection in the affected joint.
- Active local or systemic infection that may affect the prosthetic joint.
- Insufficient bone stock on femoral or tibial surfaces.
- Skeletal immaturity.
- Neuropathic arthropathy.
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 TM Monoblock TibiaPrimary cementless tibia total knee arthroplasty | Device | Monoblock |
| NexGen TM Modular TibiaPrimary cementless tibia total knee arthroplasty | Device | Modular |
Primary outcome
Radiograph Assessment of Progressive Tibial Radiolucencies
Time frame: 2 years
Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of >0.5mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.
2 secondary outcomes
Oxford Knee Score
Time frame: 2 years
Revision Rate
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kacy Arnold, RN, MBA study director
Zimmer Biomet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGen TM Monoblock Tibia and NexGen TM Modular Tibia in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 7 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 5 Dec 2024). 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?
Radiograph Assessment of Progressive Tibial Radiolucencies (time frame: 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 30 Dec 2024.