The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to: Compare the accuracy of long leg alignment achieved by the two types of procedure. Compare the number of optimal implantations achieved by the two types of procedure. Compare the clinical performance of the knee replacement in subjects who have undergone one of the two types of procedure. Compare the functional outcome achieved by subjects who have undergone one of the two types of procedure. Compare the interface radiographic appearance 5 years post-operatively between the two types of procedure. Compare the accuracy and precision of long leg alignment achieved by the two types of procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy and precision between the final follow-up and baseline. Compare the Adverse Events experienced by the subjects who have undergone the two types of procedure.
Primary endpoint: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA, specifically 3 months to demonstrate the variability of the mechanical axis. Secondary endpoints: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA specifically to demonstrate the proportion of procedures that fall within a satisfactory alignment window in either group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation
Newport Orthopaedic Institute
Newport Beach, California, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Joint Reconstruction Center, UPMC
Pittsburgh, Pennsylvania, United States
Sportsmed
Adelaide, South Australia, Australia
Ascot & Mercy Hospital
Remuera, Aukland 5, New Zealand
To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)
Time frame: 6 - 12 Weeks
To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
An independent radiographic observer will determine and record alignment.
Time frame: operative
To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.
Time frame: 4 - 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: Pre-op
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 4 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 8 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 6 Months
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 1 year
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 2 years
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time frame: 5 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: pre-op
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 4 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 8 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 12 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 6 Months
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 1 Year
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 2 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time frame: 5 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: pre-op
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 4 Weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 8 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 12 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 6 months
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 1 year
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 2 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
Time frame: 5 years
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
Time frame: pre-op
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
Time frame: 4 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
Time frame: 8 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
Time frame: 12 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
Time frame: 6 months
To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
An independent radiographer will observe and record alignment.
Time frame: 5 years
To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.
An independent radiographer will observe and record alignment
Time frame: 5 years
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.
Time frame: pre-op
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).
Time frame: 4 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).
Time frame: 8 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).
Time frame: 12 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).
Time frame: 6 months
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