Osteoarthritis
Conditions
Keywords
Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive
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.
Interventions
DEVICEEither P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
DEVICEEither P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation
Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation
Sponsors
DePuy International
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 6 - 12 Weeks | Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 - 12 Weeks | Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension. |
| To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | Pre-op | 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. |
| To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | pre-op | 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. |
| To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | pre-op | 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. |
| 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. | operative | An independent radiographic observer will determine and record alignment. |
| To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 5 years | An independent radiographer will observe and record alignment. |
| To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment. | 5 years | An independent radiographer will observe and record alignment |
| To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | pre-op | 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. |
| To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | pre-op | 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. |
Countries
Australia, New Zealand, United States
Participant flow
Recruitment details
86 subjects were enrolled at 5 sites.
Pre-assignment details
2 subjects were intraoperatively excluded and did not receive surgery.
Participants by arm
| Arm | Count |
|---|---|
| MiTKR CAS Arm 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 | 32 |
| Conventional TKR Arm Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique | 52 |
| Total | 84 |
Baseline characteristics
| Characteristic | MiTKR CAS Arm | Conventional TKR Arm | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 6.3 | 65.5 years STANDARD_DEVIATION 8.8 | 65.8 years STANDARD_DEVIATION 7.9 |
| Gender Female | 18 participants | 31 participants | 49 participants |
| Gender Male | 13 participants | 21 participants | 34 participants |
| Region of Enrollment Australia | 9 participants | 12 participants | 21 participants |
| Region of Enrollment New Zealand | 7 participants | 14 participants | 21 participants |
| Region of Enrollment United States | 16 participants | 26 participants | 42 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 32 | 7 / 52 |
| serious Total, serious adverse events | 2 / 32 | 9 / 52 |
Outcome results
Primary
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
Population: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.
Secondary
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
Population: There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1403.9 Feet | Standard Deviation 442 |
| Conventional TKR Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1393.7 Feet | Standard Deviation 470 |
Secondary
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
Population: There were 5 missing outcomes for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1094.1 Feet | Standard Deviation 326 |
| Conventional TKR Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 990.6 Feet | Standard Deviation 386 |
Secondary
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
Population: There were 21 missing outcomes and 1 consent withdrawal for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 948.4 Feet | Standard Deviation 395 |
| Conventional TKR Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 922.5 Feet | Standard Deviation 391 |
Secondary
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
Population: There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1249.9 Feet | Standard Deviation 402 |
| Conventional TKR Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1079.4 Feet | Standard Deviation 382 |
Secondary
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
Population: There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1287.1 Feet | Standard Deviation 410 |
| Conventional TKR Arm | To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 1259.5 Feet | Standard Deviation 588 |
Secondary
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
Population: There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 85.5 points | Standard Deviation 17.5 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 80.9 points | Standard Deviation 15.1 |
Secondary
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
Population: There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 83.3 points | Standard Deviation 18.2 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 84.6 points | Standard Deviation 15.1 |
Secondary
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
Population: There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 86.5 points | Standard Deviation 13.4 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 89.6 points | Standard Deviation 11.5 |
Secondary
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
Population: There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 76.4 points | Standard Deviation 20.5 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 87.5 points | Standard Deviation 10.2 |
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.
Secondary
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
Population: Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 54.1 points | Standard Deviation 16 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 45.3 points | Standard Deviation 13.8 |
Secondary
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
Population: There were 19 missing outcomes and 1 consent withdrawal for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 63.8 points | Standard Deviation 19.5 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 66.3 points | Standard Deviation 16.6 |
Secondary
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
Population: There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 78.8 points | Standard Deviation 16.8 |
| Conventional TKR Arm | To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 77.5 points | Standard Deviation 15.6 |
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.
Secondary
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
Population: There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 20.0 points | Standard Deviation 8.4 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 20.2 points | Standard Deviation 7 |
Secondary
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
Population: There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 16.5 points | Standard Deviation 5.1 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 17.5 points | Standard Deviation 6.1 |
Secondary
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
Population: There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 17.0 points | Standard Deviation 6.6 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 17.8 points | Standard Deviation 7.5 |
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore there are no results for this outcome.
Secondary
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
Population: There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 20.2 points | Standard Deviation 7.6 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 23.7 points | Standard Deviation 7 |
Secondary
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
Population: There were 2 missing outcomes for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 33.4 points | Standard Deviation 8 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 36.1 points | Standard Deviation 7.4 |
Secondary
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
Population: There were 19 missing outcomes and 1 consent withdrawal for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 32.3 points | Standard Deviation 10.2 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 31.4 points | Standard Deviation 7.5 |
Secondary
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
Population: There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 24.7 points | Standard Deviation 7.2 |
| Conventional TKR Arm | To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 26.5 points | Standard Deviation 8.5 |
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.
Secondary
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
Population: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.
Secondary
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
Population: There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 8.4 millimeters | Standard Deviation 16.8 |
| Conventional TKR Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 7.9 millimeters | Standard Deviation 13.3 |
Secondary
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
Population: There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 4.8 millimeters | Standard Deviation 11.8 |
| Conventional TKR Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 2.9 millimeters | Standard Deviation 6 |
Secondary
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
Population: There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 10.0 millimeters | Standard Deviation 17.7 |
| Conventional TKR Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 7.5 millimeters | Standard Deviation 12.5 |
Secondary
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
Population: There were 3 missing outcomes for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 17.4 millimeters | Standard Deviation 19.8 |
| Conventional TKR Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 24.7 millimeters | Standard Deviation 24.9 |
Secondary
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
Population: There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 10.3 millimeters | Standard Deviation 17.8 |
| Conventional TKR Arm | To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 15.8 millimeters | Standard Deviation 23.4 |
Secondary
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
Population: There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 14.5 points | Standard Deviation 15.5 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 13.7 points | Standard Deviation 11.9 |
Secondary
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
Population: There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 5.9 points | Standard Deviation 9 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 6.6 points | Standard Deviation 8.5 |
Secondary
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
Population: There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 4.6 points | Standard Deviation 5.8 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 6.6 points | Standard Deviation 10 |
Secondary
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
Population: The study was terminated early for business reasons therefore there are no outcomes for this endpoint.
Secondary
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
Population: There were 4 missing outcomes for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 34.7 points | Standard Deviation 14.9 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 39.3 points | Standard Deviation 14 |
Secondary
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
Population: There were 21 missing outcomes and 1 consent withdrawal for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 26.2 points | Standard Deviation 19.2 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 27.6 points | Standard Deviation 16.5 |
Secondary
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
Population: There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 14.2 points | Standard Deviation 11.5 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 18.5 points | Standard Deviation 14.1 |
Secondary
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
Population: There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiTKR CAS Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 7.2 points | Standard Deviation 10.4 |
| Conventional TKR Arm | To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. | 7.0 points | Standard Deviation 8.7 |