Trial Outcomes & Findings for Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function (NCT NCT00710840)
NCT ID: NCT00710840
Last Updated: 2015-06-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Results posted on
2015-06-10
Participant Flow
Participant milestones
| Measure |
TKA Min
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Baseline characteristics by cohort
| Measure |
TKA Min
n=22 Participants
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=22 Participants
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
BMI
|
30.5 kg\m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.3 kg\m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
30.9 kg\m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured pre-operatively; post-surgery at 4 weeks and 12 weeksOutcome measures
| Measure |
TKA Min
n=22 Participants
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=19 Participants
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Quadriceps Muscle Force
Quadriceps Strength Preop
|
1.27 Nm/kg
Standard Deviation 0.56
|
1.37 Nm/kg
Standard Deviation 0.56
|
|
Quadriceps Muscle Force
Quadriceps Strength 4 weeks Postop
|
0.79 Nm/kg
Standard Deviation 0.39
|
0.66 Nm/kg
Standard Deviation 0.23
|
|
Quadriceps Muscle Force
Quadriceps Strength 12 weeks Postop
|
1.24 Nm/kg
Standard Deviation 0.40
|
1.20 Nm/kg
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: Measured pre-operatively; post-surgery at 4 weeks and 12 weeksKnee Flexion Active Range of Motion (AROM)
Outcome measures
| Measure |
TKA Min
n=22 Participants
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=19 Participants
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Knee Range of Motion
Flexion AROM Preop
|
120.0 degrees
Standard Deviation 16.7
|
119.3 degrees
Standard Deviation 15.8
|
|
Knee Range of Motion
Flexion AROM 4 weeks Postop
|
98.6 degrees
Standard Deviation 12.3
|
96.9 degrees
Standard Deviation 13.9
|
|
Knee Range of Motion
Flexion AROM 12 weeks Postop
|
113.5 degrees
Standard Deviation 10.6
|
112.4 degrees
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Measured pre-operatively; post-surgery at 4 weeks and 12 weeksOutcome measures
| Measure |
TKA Min
n=22 Participants
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=19 Participants
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Functional Performance: 6 Minute Walk (6MW) Distance
6MW Preop
|
464.0 Meters
Standard Deviation 124.9
|
434.7 Meters
Standard Deviation 147.8
|
|
Functional Performance: 6 Minute Walk (6MW) Distance
6MW 4 weeks Postop
|
345.9 Meters
Standard Deviation 111.2
|
326.6 Meters
Standard Deviation 125.7
|
|
Functional Performance: 6 Minute Walk (6MW) Distance
6MW 12 weeks Postop
|
474.6 Meters
Standard Deviation 105.4
|
448.5 Meters
Standard Deviation 124.8
|
SECONDARY outcome
Timeframe: Measured pre-operatively; post-surgery at 4 weeks and 12 weeksThis outcome measures the time (seconds) it takes to climb up and back down 12 steps.
Outcome measures
| Measure |
TKA Min
n=22 Participants
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=19 Participants
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Functional Performance: Stair Climb Test
Stair Climb Preop
|
18.1 Seconds
Standard Deviation 9.7
|
19.4 Seconds
Standard Deviation 17.2
|
|
Functional Performance: Stair Climb Test
Stair Climb 4 weeks Postop
|
35.0 Seconds
Standard Deviation 18.7
|
32.2 Seconds
Standard Deviation 17.3
|
|
Functional Performance: Stair Climb Test
Stair Climb 12 weeks Postop
|
15.9 Seconds
Standard Deviation 8.7
|
16.4 Seconds
Standard Deviation 7.8
|
Adverse Events
TKA Min
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
TKA Traditional
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TKA Min
n=22 participants at risk
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=22 participants at risk
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
4.5%
1/22
|
0.00%
0/22
|
Other adverse events
| Measure |
TKA Min
n=22 participants at risk
Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
|
TKA Traditional
n=22 participants at risk
Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
|
|---|---|---|
|
Surgical and medical procedures
Femoral Notching
|
9.1%
2/22
|
9.1%
2/22
|
|
Surgical and medical procedures
Retained Cement
|
4.5%
1/22
|
9.1%
2/22
|
|
Surgical and medical procedures
Heterotopic Ossification
|
0.00%
0/22
|
4.5%
1/22
|
|
Surgical and medical procedures
Retained Drill Bit
|
0.00%
0/22
|
4.5%
1/22
|
|
Surgical and medical procedures
Intra-Operative Fracture
|
0.00%
0/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Hematoma\Excessive Bleeding
|
9.1%
2/22
|
27.3%
6/22
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/22
|
9.1%
2/22
|
|
General disorders
Poor Bone Quality
|
0.00%
0/22
|
4.5%
1/22
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/22
|
4.5%
1/22
|
|
Cardiac disorders
Transient EKG Abnormality
|
0.00%
0/22
|
4.5%
1/22
|
|
Nervous system disorders
Hypersensitivity to Light Touch
|
4.5%
1/22
|
0.00%
0/22
|
|
Surgical and medical procedures
Surgical Malalignment
|
18.2%
4/22
|
18.2%
4/22
|
Additional Information
Dr. Jennifer Stevens-Lapsley
University of Colorado Denver, Anschutz Medical Center
Phone: 303-724-9170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place