Osteoarthritis
Conditions
Keywords
Surgical procedures, Minimally invasive, Arthroplasty, Knee
Brief summary
If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.
Detailed description
Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. 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. Paired two-tailed t tests with a level of significance of p \< 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.
Interventions
PROCEDUREtotal knee arthroplasty
Sponsors
Jia-kuo yu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of osteoarthritis * Indication of TKA
Exclusion criteria
* Bilateral total knee replacements * Rheumatoid arthritis * Genu valgus over than 10 degrees and genu varum over 15 degrees * ROM (Range of motion) of preoperative knee joint less than 100 degree.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proprioception of the Knee Post Operation | six months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HSS(Hospital for Special Surgery) Score of the Knee Joint | 6 months | Scale Name:score scale range:0\ 100,and a higher values represent a better outcome |
| VAS(Visual Analogue Scale/Score) of the Knee Joint | 6 months | Scale Name:score scale range:0\ 100,and a higher values represent a worse outcome |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
Patients refused to receive MIS-QS TKA or MIS TKA.
Participants by arm
| Arm | Count |
|---|---|
| QS-TKA patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty | 42 |
| MIS-TKA patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Six Months After Surgery | Lost to Follow-up | 2 | 1 |
| Six Weeks After Surgery | Lost to Follow-up | 1 | 0 |
| Three Months After Surgery | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | QS-TKA | MIS-TKA | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 6.1 | 64.5 years STANDARD_DEVIATION 7.1 | 65.4 years STANDARD_DEVIATION 6.8 |
| Preoperative HSS score,Continuous | 56.2 units on a scale STANDARD_DEVIATION 13.8 | 59.9 units on a scale STANDARD_DEVIATION 14.6 | 58.1 units on a scale STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 36 Participants | 32 Participants | 68 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Proprioception of the Knee Post Operation
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
Time frame: six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 10 ~ 20 degree | 10.3 units on a scale | Standard Error 6.8 |
| MIS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 30 ~ 40 degree | 7.3 units on a scale | Standard Error 3.2 |
| MIS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 80 ~ 90 degree | 8.0 units on a scale | Standard Error 3.2 |
| MIS-TKA | Proprioception of the Knee Post Operation | one week after operation at 10 ~ 20 degree | 8.6 units on a scale | Standard Error 2.8 |
| MIS-TKA | Proprioception of the Knee Post Operation | one week after operation at 30 ~40 degree | 6.3 units on a scale | Standard Error 1.9 |
| MIS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 10 ~ 20 degree | 7.7 units on a scale | Standard Error 3.3 |
| MIS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 30 ~ 40 degree | 11.6 units on a scale | Standard Error 4.7 |
| MIS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 80 ~ 90 degree | 8.1 units on a scale | Standard Error 2.8 |
| MIS-TKA | Proprioception of the Knee Post Operation | three months after operation at 10 ~ 20 degree | 4.9 units on a scale | Standard Error 2.8 |
| MIS-TKA | Proprioception of the Knee Post Operation | three months after operation at 30 ~ 40 degree | 8.6 units on a scale | Standard Error 5 |
| MIS-TKA | Proprioception of the Knee Post Operation | three months after operation at 80 ~ 90 degree | 6.3 units on a scale | Standard Error 3.8 |
| MIS-TKA | Proprioception of the Knee Post Operation | six months after operation at 10 ~ 20 degree | 3.6 units on a scale | Standard Error 3.4 |
| MIS-TKA | Proprioception of the Knee Post Operation | six months after operation at 30 ~ 40 degree | 11.4 units on a scale | Standard Error 6.9 |
| MIS-TKA | Proprioception of the Knee Post Operation | six months after operation at 80 ~ 90 degree | 6.6 units on a scale | Standard Error 4.5 |
| QS-TKA | Proprioception of the Knee Post Operation | three months after operation at 80 ~ 90 degree | 4.7 units on a scale | Standard Error 3.1 |
| QS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 10 ~ 20 degree | 6.3 units on a scale | Standard Error 2.9 |
| QS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 80 ~ 90 degree | 5.8 units on a scale | Standard Error 2.3 |
| QS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 30 ~ 40 degree | 6.4 units on a scale | Standard Error 2.1 |
| QS-TKA | Proprioception of the Knee Post Operation | six months after operation at 30 ~ 40 degree | 8.0 units on a scale | Standard Error 4 |
| QS-TKA | Proprioception of the Knee Post Operation | preoperative proprioception at 80 ~ 90 degree | 7.0 units on a scale | Standard Error 3.7 |
| QS-TKA | Proprioception of the Knee Post Operation | three months after operation at 10 ~ 20 degree | 4.2 units on a scale | Standard Error 2.7 |
| QS-TKA | Proprioception of the Knee Post Operation | one week after operation at 10 ~ 20 degree | 5.0 units on a scale | Standard Error 1.3 |
| QS-TKA | Proprioception of the Knee Post Operation | six months after operation at 10 ~ 20 degree | 3.8 units on a scale | Standard Error 3.7 |
| QS-TKA | Proprioception of the Knee Post Operation | one week after operation at 30 ~40 degree | 4.0 units on a scale | Standard Error 1.5 |
| QS-TKA | Proprioception of the Knee Post Operation | three months after operation at 30 ~ 40 degree | 7.4 units on a scale | Standard Error 4.6 |
| QS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 10 ~ 20 degree | 5.2 units on a scale | Standard Error 3.1 |
| QS-TKA | Proprioception of the Knee Post Operation | six months after operation at 80 ~ 90 degree | 5.5 units on a scale | Standard Error 3.7 |
| QS-TKA | Proprioception of the Knee Post Operation | six weeks after operation at 30 ~ 40 degree | 8.3 units on a scale | Standard Error 5.1 |
p-value: <0.05t-test, 2 sided
Secondary
HSS(Hospital for Special Surgery) Score of the Knee Joint
Scale Name:score scale range:0\ 100,and a higher values represent a better outcome
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | one week after operation | 65.3 units on a scale | Standard Deviation 9.1 |
| MIS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | six weeks after operation | 69.6 units on a scale | Standard Deviation 9.3 |
| MIS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | three months after operation | 76.3 units on a scale | Standard Deviation 9.3 |
| MIS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | six months after operation | 81.1 units on a scale | Standard Deviation 7.7 |
| QS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | six months after operation | 82.4 units on a scale | Standard Deviation 5.8 |
| QS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | one week after operation | 68.4 units on a scale | Standard Deviation 6.2 |
| QS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | three months after operation | 77.8 units on a scale | Standard Deviation 9.5 |
| QS-TKA | HSS(Hospital for Special Surgery) Score of the Knee Joint | six weeks after operation | 74.5 units on a scale | Standard Deviation 7.7 |
p-value: <0.05t-test, 2 sided
Secondary
VAS(Visual Analogue Scale/Score) of the Knee Joint
Scale Name:score scale range:0\ 100,and a higher values represent a worse outcome
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | one week after operation | 2.5 units on a scale | Standard Deviation 1.5 |
| MIS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | six weeks after operation | 2.6 units on a scale | Standard Deviation 1.8 |
| MIS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | three months after operation | 1.8 units on a scale | Standard Deviation 1.7 |
| MIS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | six months after operation | 1.5 units on a scale | Standard Deviation 1 |
| QS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | six weeks after operation | 2.7 units on a scale | Standard Deviation 1.7 |
| QS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | one week after operation | 2.2 units on a scale | Standard Deviation 1.7 |
| QS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | three months after operation | 1.5 units on a scale | Standard Deviation 1.2 |
| QS-TKA | VAS(Visual Analogue Scale/Score) of the Knee Joint | six months after operation | 1.4 units on a scale | Standard Deviation 0.6 |
p-value: <0.05t-test, 2 sided