Trial Outcomes & Findings for Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study (NCT NCT00733330)

NCT ID: NCT00733330

Last Updated: 2014-08-15

Results Overview

Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 86 participants
• Primary outcome timeframe: 6 - 12 Weeks
• Results posted on: 2014-08-15

Participant Flow

86 subjects were enrolled at 5 sites.

2 subjects were intraoperatively excluded and did not receive surgery.

Participant milestones

Measure	MiTKR CAS Arm Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation	Conventional TKR Arm Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
Overall Study STARTED	32	52
Overall Study COMPLETED	30	48
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MiTKR CAS Arm n=32 Participants 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	Conventional TKR Arm n=52 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique	Total n=84 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 6.3 • n=5 Participants	65.5 years STANDARD_DEVIATION 8.8 • n=7 Participants	65.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Gender Female	18 participants n=5 Participants	31 participants n=7 Participants	49 participants n=5 Participants
Gender Male	13 participants n=5 Participants	21 participants n=7 Participants	34 participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	26 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Australia	9 participants n=5 Participants	12 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment New Zealand	7 participants n=5 Participants	14 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 - 12 Weeks

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

Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

An independent radiographic observer will determine and record alignment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-op

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=31 Participants 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	Conventional TKR Arm n=50 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	45.3 points Standard Deviation 13.8

SECONDARY outcome

Timeframe: 4 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=20 Participants 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	Conventional TKR Arm n=44 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	66.3 points Standard Deviation 16.6

SECONDARY outcome

Timeframe: 8 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=20 Participants 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	Conventional TKR Arm n=42 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	77.5 points Standard Deviation 15.6

SECONDARY outcome

Timeframe: 12 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=13 Participants 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	Conventional TKR Arm n=35 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	80.9 points Standard Deviation 15.1

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=22 Participants 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	Conventional TKR Arm n=48 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	84.6 points Standard Deviation 15.1

SECONDARY outcome

Timeframe: 1 year

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=17 Participants 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	Conventional TKR Arm n=39 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	89.6 points Standard Deviation 11.5

SECONDARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=7 Participants 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	Conventional TKR Arm n=30 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	87.5 points Standard Deviation 10.2

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-op

Population: There were 2 missing outcomes for this endpoint.

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.

Outcome measures

Measure	MiTKR CAS Arm n=31 Participants 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	Conventional TKR Arm n=51 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	33.4 points Standard Deviation 8.0	36.1 points Standard Deviation 7.4

SECONDARY outcome

Timeframe: 4 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=19 Participants 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	Conventional TKR Arm n=45 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	32.3 points Standard Deviation 10.2	31.4 points Standard Deviation 7.5

SECONDARY outcome

Timeframe: 8 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=20 Participants 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	Conventional TKR Arm n=42 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	24.7 points Standard Deviation 7.2	26.5 points Standard Deviation 8.5

SECONDARY outcome

Timeframe: 12 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=12 Participants 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	Conventional TKR Arm n=35 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	20.2 points Standard Deviation 7.6	23.7 points Standard Deviation 7.0

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=22 Participants 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	Conventional TKR Arm n=48 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	20.0 points Standard Deviation 8.4	20.2 points Standard Deviation 7.0

SECONDARY outcome

Timeframe: 1 Year

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=17 Participants 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	Conventional TKR Arm n=40 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	16.5 points Standard Deviation 5.1	17.5 points Standard Deviation 6.1

SECONDARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=7 Participants 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	Conventional TKR Arm n=30 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	17.0 points Standard Deviation 6.6	17.8 points Standard Deviation 7.5

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-op

Population: There were 4 missing outcomes for this endpoint.

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.

Outcome measures

Measure	MiTKR CAS Arm n=30 Participants 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	Conventional TKR Arm n=50 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	34.7 points Standard Deviation 14.9	39.3 points Standard Deviation 14.0

SECONDARY outcome

Timeframe: 4 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=19 Participants 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	Conventional TKR Arm n=43 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	26.2 points Standard Deviation 19.2	27.6 points Standard Deviation 16.5

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=19 Participants 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	Conventional TKR Arm n=40 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	14.2 points Standard Deviation 11.5	18.5 points Standard Deviation 14.1

SECONDARY outcome

Timeframe: 12 weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=12 Participants 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	Conventional TKR Arm n=32 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	14.5 points Standard Deviation 15.5	13.7 points Standard Deviation 11.9

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=22 Participants 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	Conventional TKR Arm n=42 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	7.2 points Standard Deviation 10.4	7.0 points Standard Deviation 8.7

SECONDARY outcome

Timeframe: 1 year

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=16 Participants 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	Conventional TKR Arm n=37 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	5.9 points Standard Deviation 9.0	6.6 points Standard Deviation 8.5

SECONDARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=5 Participants 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	Conventional TKR Arm n=29 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	4.6 points Standard Deviation 5.8	6.6 points Standard Deviation 10.0

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-op

Population: There were 3 missing outcomes for this endpoint.

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.

Outcome measures

Measure	MiTKR CAS Arm n=31 Participants 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	Conventional TKR Arm n=50 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	17.4 millimeters Standard Deviation 19.8	24.7 millimeters Standard Deviation 24.9

SECONDARY outcome

Timeframe: 4 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=18 Participants 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	Conventional TKR Arm n=42 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	10.3 millimeters Standard Deviation 17.8	15.8 millimeters Standard Deviation 23.4

SECONDARY outcome

Timeframe: 8 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=20 Participants 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	Conventional TKR Arm n=35 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	8.4 millimeters Standard Deviation 16.8	7.9 millimeters Standard Deviation 13.3

SECONDARY outcome

Timeframe: 12 Weeks

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=13 Participants 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	Conventional TKR Arm n=30 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	10.0 millimeters Standard Deviation 17.7	7.5 millimeters Standard Deviation 12.5

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Measure	MiTKR CAS Arm n=22 Participants 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	Conventional TKR Arm n=46 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	4.8 millimeters Standard Deviation 11.8	2.9 millimeters Standard Deviation 6.0

SECONDARY outcome

Timeframe: 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.

An independent radiographer will observe and record alignment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

An independent radiographer will observe and record alignment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-op

Population: There were 5 missing outcomes for this endpoint.

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.

Outcome measures

Measure	MiTKR CAS Arm n=31 Participants 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	Conventional TKR Arm n=48 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	990.6 Feet Standard Deviation 386

SECONDARY outcome

Timeframe: 4 weeks

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

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).

Outcome measures

Measure	MiTKR CAS Arm n=18 Participants 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	Conventional TKR Arm n=44 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	922.5 Feet Standard Deviation 391

SECONDARY outcome

Timeframe: 8 weeks

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

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).

Outcome measures

Measure	MiTKR CAS Arm n=20 Participants 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	Conventional TKR Arm n=41 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	1079.4 Feet Standard Deviation 382

SECONDARY outcome

Timeframe: 12 weeks

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

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).

Outcome measures

Measure	MiTKR CAS Arm n=13 Participants 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	Conventional TKR Arm n=35 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	1259.5 Feet Standard Deviation 588

SECONDARY outcome

Timeframe: 6 months

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

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).

Outcome measures

Measure	MiTKR CAS Arm n=22 Participants 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	Conventional TKR Arm n=45 Participants Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
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	1393.7 Feet Standard Deviation 470

Adverse Events

MiTKR CAS Arm

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Conventional TKR Arm

Serious events: 9 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	MiTKR CAS Arm n=32 participants at risk Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation	Conventional TKR Arm n=52 participants at risk Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
Nervous system disorders Nervous System Disorder	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	9.6% 5/52 • Number of events 5 • Adverse Events were collected from baseline through December 2008.
General disorders Chest Pain	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Psychiatric disorders Confusional State	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Fall	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	3.8% 2/52 • Number of events 2 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Laceration	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Ligament Rupture	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Infections and infestations Postoperative Wound Infection	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 4 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 2 • Adverse Events were collected from baseline through December 2008.
Vascular disorders Thrombosis	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	1.9% 1/52 • Number of events 1 • Adverse Events were collected from baseline through December 2008.
Infections and infestations Cellulitis	3.1% 1/32 • Number of events 1 • Adverse Events were collected from baseline through December 2008.	0.00% 0/52 • Adverse Events were collected from baseline through December 2008.
Infections and infestations Infection	3.1% 1/32 • Number of events 1 • Adverse Events were collected from baseline through December 2008.	0.00% 0/52 • Adverse Events were collected from baseline through December 2008.
Infections and infestations Wound Abscess	3.1% 1/32 • Number of events 1 • Adverse Events were collected from baseline through December 2008.	0.00% 0/52 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Wound Complication	3.1% 1/32 • Number of events 1 • Adverse Events were collected from baseline through December 2008.	0.00% 0/52 • Adverse Events were collected from baseline through December 2008.

Other adverse events

Measure	MiTKR CAS Arm n=32 participants at risk Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation	Conventional TKR Arm n=52 participants at risk Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 2/32 • Number of events 2 • Adverse Events were collected from baseline through December 2008.	7.7% 4/52 • Number of events 5 • Adverse Events were collected from baseline through December 2008.
Musculoskeletal and connective tissue disorders Joint Swelling	9.4% 3/32 • Number of events 3 • Adverse Events were collected from baseline through December 2008.	5.8% 3/52 • Number of events 4 • Adverse Events were collected from baseline through December 2008.
General disorders Pain	0.00% 0/32 • Adverse Events were collected from baseline through December 2008.	5.8% 3/52 • Number of events 3 • Adverse Events were collected from baseline through December 2008.
Injury, poisoning and procedural complications Joint Injury	9.4% 3/32 • Number of events 3 • Adverse Events were collected from baseline through December 2008.	0.00% 0/52 • Adverse Events were collected from baseline through December 2008.

Additional Information

Kimberly Dwyer

DePuy International

Email: kdwyer2@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.
• Publication restrictions are in place

Restriction type: OTHER