Minimally Invasive Total Knee Replacement - Navigated Ver... | NCT00733330

NCT00733330

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional TKR arm	Other	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
MiTKR CAS arm	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique	Device	Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Newport Orthopaedic Institute		Newport Beach	California	92651	United States
Wake Forest University

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
FG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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)

The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.

Posted

6 - 12 Weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG0000 OG0010

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.

The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.

Posted

operative

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

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.

The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.

Posted

4 - 12 Weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

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.

Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.

Posted

Mean

Standard Deviation

points

Pre-op

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

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.

There were 19 missing outcomes and 1 consent withdrawal for this endpoint.

Posted

Mean

Standard Deviation

points

4 Weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.

Posted

Mean

Standard Deviation

points

8 Weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.

Posted

Mean

Standard Deviation

points

12 Weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.

Posted

Mean

Standard Deviation

points

6 Months

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.

Posted

Mean

Standard Deviation

points

1 year

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.

Posted

Mean

Standard Deviation

points

2 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.

Posted

5 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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.

There were 2 missing outcomes for this endpoint.

Posted

Mean

Standard Deviation

points

pre-op

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 19 missing outcomes and 1 consent withdrawal for this outcome.

Posted

Mean

Standard Deviation

points

4 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

8 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.

Posted

Mean

Standard Deviation

points

12 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.

Posted

Mean

Standard Deviation

points

6 Months

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.

Posted

Mean

Standard Deviation

points

1 Year

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

2 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

The study was terminated before completion due to business purposes, therefore there are no results for this outcome.

Posted

5 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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.

There were 4 missing outcomes for this endpoint.

Posted

Mean

Standard Deviation

points

pre-op

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 21 missing outcomes and 1 consent withdrawal for this endpoint.

Posted

Mean

Standard Deviation

points

4 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

8 weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

12 weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

6 months

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

1 year

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

points

2 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

The study was terminated early for business reasons therefore there are no outcomes for this endpoint.

Posted

5 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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.

There were 3 missing outcomes for this endpoint.

Posted

Mean

Standard Deviation

millimeters

pre-op

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.

Posted

Mean

Standard Deviation

millimeters

4 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.

Posted

Mean

Standard Deviation

millimeters

8 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

millimeters

12 Weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

Secondary

To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

millimeters

6 months

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants

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.

The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.

Posted

5 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Secondary

To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.

An independent radiographer will observe and record alignment

The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.

Posted

5 years

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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.

There were 5 missing outcomes for this endpoint.

Posted

Mean

Standard Deviation

Feet

pre-op

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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).

There were 21 missing outcomes and 1 consent withdrawal for this endpoint.

Posted

Mean

Standard Deviation

Feet

4 weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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).

There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

Feet

8 weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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).

There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

Feet

12 weeks

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

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).

There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.

Posted

Mean

Standard Deviation

Feet

6 months

ID	Title	Description
OG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
OG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Nervous System Disorder	Nervous system disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 affected52 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0015 events5 affected52 at risk
Chest Pain	General disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Confusional State	Psychiatric disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA 16.0	EG0000 events0 affected32 at risk EG0012 events2 affected52 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0014 events1 affected52 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0012 events1 affected52 at risk
Thrombosis	Vascular disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0011 events1 affected52 at risk
Cellulitis	Infections and infestations	MedDRA 16.0	EG0001 events1 affected32 at risk EG0010 events0 affected52 at risk
Infection	Infections and infestations	MedDRA 16.0	EG0001 events1 affected32 at risk EG0010 events0 affected52 at risk
Wound Abscess	Infections and infestations	MedDRA 16.0	EG0001 events1 affected32 at risk EG0010 events0 affected52 at risk
Wound Complication	Injury, poisoning and procedural complications	MedDRA 16.0	EG0001 events1 affected32 at risk EG0010 events0 affected52 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0002 events2 affected32 at risk EG0015 events4 affected52 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0003 events3 affected32 at risk EG0014 events3 affected52 at risk
Pain	General disorders	MedDRA 16.0	EG0000 events0 affected32 at risk EG0013 events3 affected52 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 16.0	EG0003 events3 affected32 at risk EG0010 events0 affected52 at risk

ID	Term
D010003	Osteoarthritis
D001072	Apraxias

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D011596	Psychomotor Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MiTKR CAS Arm	Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation			2	32	4	32
EG001	Conventional TKR Arm	Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique			9	52	7	52