Knee Osteoarthritis
Conditions
Keywords
Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide
Brief summary
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.
Detailed description
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.
Interventions
PROCEDUREStandard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
PROCEDUREPatient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 60-90 * Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following: * Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved; * Correction of varus or valgus. * Willing to participate and return for follow-up study visits.
Exclusion criteria
* Vascular insufficiency * Previous deep vein thrombosis and pulmonary embolism * Previous osteotomy * Previous patella fracture or surgery * Previous healed tibia or femur fractures * Previous joint replacement surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films | 3 Months Post-operative | Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Bleeding | Intra-operative |
| Operative time | During the procedure |
| Hemoglobin level | Post-operative day1, 2, 3 |
| WOMAC score | 6 weeks |
| Blood volume in suction drain | Post-operative Day 2 |
Other
| Measure | Time frame |
|---|---|
| WOMAC Score | 2 years |
Countries
Thailand
Outcome results
None listed