Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
160 participants
INTERVENTIONAL
2017-10-03
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Monoblock
Subjects that receive the NexGen TM Monoblock Tibia
NexGen TM Monoblock Tibia
Primary cementless tibia total knee arthroplasty
Modular
Subjects that receive the NexGen TM Modular Tibia
NexGen TM Modular Tibia
Primary cementless tibia total knee arthroplasty
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NexGen TM Monoblock Tibia
Primary cementless tibia total knee arthroplasty
NexGen TM Modular Tibia
Primary cementless tibia total knee arthroplasty
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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:
1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
2. Collagen disorders and/or avascular necrosis of the femoral condyle.
3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
4. Moderate valgus, varus, or flexion deformities.
5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
3. Patient has participated in the study-related Informed Consent process.
4. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
5. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
6. Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.
Exclusion Criteria
2. Active local or systemic infection that may affect the prosthetic joint.
3. Insufficient bone stock on femoral or tibial surfaces.
4. Skeletal immaturity.
5. Neuropathic arthropathy.
6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
7. A stable, painless arthrodesis in a satisfactory functional position.
8. Severe instability secondary to the absence of collateral ligament integrity.
9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
10. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
11. Patient is currently participating in any other surgical intervention studies or pain management studies.
12. Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
13. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kacy Arnold, RN, MBA
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LA BioMed at Harbor-UCLA Medical Center
Torrance, California, United States
Cornerstone Orthopaedics & Sports Medicine, P.C.
Wheat Ridge, Colorado, United States
Franciscan Health
Mooresville, Indiana, United States
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, United States
Woods Mill Orthopedics, Ltd
Chesterfield, Missouri, United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K.CR.I.G.16.34
Identifier Type: -
Identifier Source: org_study_id