Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
* Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged between 18 and 80 years inclusive. Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol. Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation. Subjects who have given consent to the transfer of his/her information to DePuy. Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. Exclusion Criteria: Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis. Subjects who have a fixed flexion contracture of greater than 10º. Subjects who are clinically obese i.e. BMI ≥30. Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study. Female subjects who are pregnant or lactating. Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes. Subjects who have participated in a clinical investigation with an investigational product in the last 3 months. Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims. Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee. Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy. Subjects who require simultaneous bilateral total knee replacements. Subjects who have had a contralateral TKA performed less than six months before the proposed TKA. Subjects who have had a contralateral TKA and that knee was previously entered in the study. Subjects who, in the opinion of the surgeon, will require a contralateral TKA within 6 months of the index procedure. Subjects in whom the surgeon intends to implant a knee component that is not one of those listed in Table 1. Subjects who have inflammatory arthritis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional TKR arm<br>Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique | Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique<br>* Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation<br>|
| Active Comparator: MiTKR CAS arm<br>Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation | Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation<br>* Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 - 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 5 years | 
| To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment. | An independent radiographer will observe and record alignment | 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. | 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). | 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). | 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). | 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). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive