Osteoarthritis
Conditions
Keywords
Total knee arthroplasty
Brief summary
The purpose of this study is to compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.
Interventions
PROCEDURETotal knee arthroplasty
staged bilateral total knee arthroplasty (not more than 7 days between surgeries)
Sponsors
Stryker Orthopaedics
Heekin Orthopedic Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is a male or non-pregnant female between the ages of 21-80. 2. Patient requires cemented primary total knee replacement. 3. Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA) or avascular necrosis (AVN). 4. Patient has intact collateral ligaments. 5. Patient has signed and dated an IRB approved study specific consent form. 6. Patient is able and willing to participate in the study according to the protocol for the full length of the expected term of follow-up, and to follow their physician's directions. 7. Patient has failed to respond to conservative treatment modalities.
Exclusion criteria
1. Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee. 2. Patient is morbidly obese, \>60% over ideal body weight for frame and height. 3. Patient has a deformity at the involved knee greater than 45 degrees of flexion, 45 degrees of varus or 45 degrees of valgus. 4. Patient has an active or suspected latent infection in or about the knee joint. 5. Patient has a malignancy in the area of the involved knee joint. 6. Patient has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 7. Patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 8. Female patient is or plans to become pregnant during the course of the study. 9. Patient has a known sensitivity to device materials. 10. Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength 11. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 2 year | The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain |
Secondary
| Measure | Time frame |
|---|---|
| Quadriceps Strength | 2 year |
Countries
United States
Participant flow
Recruitment details
Forty consecutive patients who underwent staged bilateral TKA (within no more than 7 days)were assessed at 2,6, 12 weeks and 6,12, and24 months postoperatively
Pre-assignment details
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
Participants by arm
| Arm | Count |
|---|---|
| Median Parepatellar Approach or Minimidvastus Approach Total knee arthroplasty : staged bilateral total knee arthroplasty | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Median Parepatellar Approach or Minimidvastus Approach |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 65.13 years STANDARD_DEVIATION 6.49 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Knee Society Score
The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Parapatellar Approach | Knee Society Score | 98.70 score | Standard Deviation 2.32 |
| Mini-midvastus Approach | Knee Society Score | 99.03 score | Standard Deviation 1.92 |
Secondary
Quadriceps Strength
Time frame: 2 year