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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Primary cementless tibia total knee arthroplasty
Primary cementless tibia total knee arthroplasty
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
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.
Time frame: 2 years
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).
Time frame: 2 years
Revision Rate
Rate of the number of revisions for any reason
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Woods Mill Orthopedics, Ltd
Chesterfield, Missouri, United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States