Trial Outcomes & Findings for Proprioception of the Knee Post MIS TKA and MIS-QS TKA (NCT NCT02160977)
NCT ID: NCT02160977
Last Updated: 2014-08-04
Results Overview
Proprioception of the knee position sense was assessed by the knee angle reproduction test (10\~20 degree, 30\~40 degree, 80\~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Scale Name:degree scale range:0\~180 degree,and a higher values represent a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
six months
Results posted on
2014-08-04
Participant Flow
From October of 2011 to June of 2012, patients who suffered from severely osteoarthritis were recruited in this study.All the patients were hospitalized patients at Peking University Third Hospital.Patients were randomly divided into two groups by digital random method.
Patients refused to receive MIS-QS TKA or MIS TKA.
Participant milestones
| Measure |
MIS-TKA
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
QS-TKA
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
|---|---|---|
|
One Week After Surgery
STARTED
|
45
|
45
|
|
One Week After Surgery
COMPLETED
|
45
|
45
|
|
One Week After Surgery
NOT COMPLETED
|
0
|
0
|
|
Six Weeks After Surgery
STARTED
|
45
|
45
|
|
Six Weeks After Surgery
COMPLETED
|
44
|
45
|
|
Six Weeks After Surgery
NOT COMPLETED
|
1
|
0
|
|
Three Months After Surgery
STARTED
|
44
|
45
|
|
Three Months After Surgery
COMPLETED
|
44
|
43
|
|
Three Months After Surgery
NOT COMPLETED
|
0
|
2
|
|
Six Months After Surgery
STARTED
|
44
|
43
|
|
Six Months After Surgery
COMPLETED
|
42
|
42
|
|
Six Months After Surgery
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
MIS-TKA
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
QS-TKA
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
|---|---|---|
|
Six Weeks After Surgery
Lost to Follow-up
|
1
|
0
|
|
Three Months After Surgery
Lost to Follow-up
|
0
|
2
|
|
Six Months After Surgery
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Proprioception of the Knee Post MIS TKA and MIS-QS TKA
Baseline characteristics by cohort
| Measure |
QS-TKA
n=42 Participants
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
MIS-TKA
n=42 Participants
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 6.1 • n=113 Participants
|
64.5 years
STANDARD_DEVIATION 7.1 • n=163 Participants
|
65.4 years
STANDARD_DEVIATION 6.8 • n=160 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=113 Participants
|
32 Participants
n=163 Participants
|
68 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=113 Participants
|
10 Participants
n=163 Participants
|
16 Participants
n=160 Participants
|
|
Preoperative HSS score,Continuous
|
56.2 units on a scale
STANDARD_DEVIATION 13.8 • n=113 Participants
|
59.9 units on a scale
STANDARD_DEVIATION 14.6 • n=163 Participants
|
58.1 units on a scale
STANDARD_DEVIATION 14.3 • n=160 Participants
|
PRIMARY outcome
Timeframe: six monthsProprioception of the knee position sense was assessed by the knee angle reproduction test (10\~20 degree, 30\~40 degree, 80\~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Scale Name:degree scale range:0\~180 degree,and a higher values represent a worse outcome
Outcome measures
| Measure |
MIS-TKA
n=42 Participants
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
QS-TKA
n=42 Participants
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
|---|---|---|
|
Proprioception of the Knee Post Operation
preoperative proprioception at 10 ~ 20 degree
|
10.3 units on a scale
Standard Error 6.8
|
6.3 units on a scale
Standard Error 2.9
|
|
Proprioception of the Knee Post Operation
preoperative proprioception at 30 ~ 40 degree
|
7.3 units on a scale
Standard Error 3.2
|
6.4 units on a scale
Standard Error 2.1
|
|
Proprioception of the Knee Post Operation
preoperative proprioception at 80 ~ 90 degree
|
8.0 units on a scale
Standard Error 3.2
|
7.0 units on a scale
Standard Error 3.7
|
|
Proprioception of the Knee Post Operation
one week after operation at 10 ~ 20 degree
|
8.6 units on a scale
Standard Error 2.8
|
5.0 units on a scale
Standard Error 1.3
|
|
Proprioception of the Knee Post Operation
one week after operation at 30 ~40 degree
|
6.3 units on a scale
Standard Error 1.9
|
4.0 units on a scale
Standard Error 1.5
|
|
Proprioception of the Knee Post Operation
six weeks after operation at 10 ~ 20 degree
|
7.7 units on a scale
Standard Error 3.3
|
5.2 units on a scale
Standard Error 3.1
|
|
Proprioception of the Knee Post Operation
six weeks after operation at 30 ~ 40 degree
|
11.6 units on a scale
Standard Error 4.7
|
8.3 units on a scale
Standard Error 5.1
|
|
Proprioception of the Knee Post Operation
six weeks after operation at 80 ~ 90 degree
|
8.1 units on a scale
Standard Error 2.8
|
5.8 units on a scale
Standard Error 2.3
|
|
Proprioception of the Knee Post Operation
three months after operation at 10 ~ 20 degree
|
4.9 units on a scale
Standard Error 2.8
|
4.2 units on a scale
Standard Error 2.7
|
|
Proprioception of the Knee Post Operation
three months after operation at 30 ~ 40 degree
|
8.6 units on a scale
Standard Error 5.0
|
7.4 units on a scale
Standard Error 4.6
|
|
Proprioception of the Knee Post Operation
three months after operation at 80 ~ 90 degree
|
6.3 units on a scale
Standard Error 3.8
|
4.7 units on a scale
Standard Error 3.1
|
|
Proprioception of the Knee Post Operation
six months after operation at 10 ~ 20 degree
|
3.6 units on a scale
Standard Error 3.4
|
3.8 units on a scale
Standard Error 3.7
|
|
Proprioception of the Knee Post Operation
six months after operation at 30 ~ 40 degree
|
11.4 units on a scale
Standard Error 6.9
|
8.0 units on a scale
Standard Error 4.0
|
|
Proprioception of the Knee Post Operation
six months after operation at 80 ~ 90 degree
|
6.6 units on a scale
Standard Error 4.5
|
5.5 units on a scale
Standard Error 3.7
|
SECONDARY outcome
Timeframe: 6 monthsScale Name:score scale range:0\~100,and a higher values represent a better outcome
Outcome measures
| Measure |
MIS-TKA
n=42 Participants
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
QS-TKA
n=42 Participants
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
|---|---|---|
|
HSS(Hospital for Special Surgery) Score of the Knee Joint
one week after operation
|
65.3 units on a scale
Standard Deviation 9.1
|
68.4 units on a scale
Standard Deviation 6.2
|
|
HSS(Hospital for Special Surgery) Score of the Knee Joint
six weeks after operation
|
69.6 units on a scale
Standard Deviation 9.3
|
74.5 units on a scale
Standard Deviation 7.7
|
|
HSS(Hospital for Special Surgery) Score of the Knee Joint
three months after operation
|
76.3 units on a scale
Standard Deviation 9.3
|
77.8 units on a scale
Standard Deviation 9.5
|
|
HSS(Hospital for Special Surgery) Score of the Knee Joint
six months after operation
|
81.1 units on a scale
Standard Deviation 7.7
|
82.4 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 6 monthsScale Name:score scale range:0\~100,and a higher values represent a worse outcome
Outcome measures
| Measure |
MIS-TKA
n=42 Participants
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty
|
QS-TKA
n=42 Participants
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty
|
|---|---|---|
|
VAS(Visual Analogue Scale/Score) of the Knee Joint
one week after operation
|
2.5 units on a scale
Standard Deviation 1.5
|
2.2 units on a scale
Standard Deviation 1.7
|
|
VAS(Visual Analogue Scale/Score) of the Knee Joint
six weeks after operation
|
2.6 units on a scale
Standard Deviation 1.8
|
2.7 units on a scale
Standard Deviation 1.7
|
|
VAS(Visual Analogue Scale/Score) of the Knee Joint
three months after operation
|
1.8 units on a scale
Standard Deviation 1.7
|
1.5 units on a scale
Standard Deviation 1.2
|
|
VAS(Visual Analogue Scale/Score) of the Knee Joint
six months after operation
|
1.5 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 0.6
|
Adverse Events
MIS-TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
QS-TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place