Osteoarthritis, Knee
Conditions
Brief summary
Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis. Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
Detailed description
Study executed with 3 centers and 69 patients.
Interventions
PROCEDUREsurgery method using CR TKP
Operation through minimal invasive surgery or standard open surgery
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patient requiring Total Knee Arthroplasty (TKA) * patients with Osteo arthritis * intact collateral ligaments and patella tendon * patients willing and able to comply with the post-operative schedule
Exclusion criteria
* patients who require a revision TKA * patients with TKA contralateral knee within 6 months with bad outcomes * patients who need a TKA on contralateral side within 2 years * intraoperative resurfacing of patella * intraoperative eversion of patella * patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy * BMI \> 30 * patients with fixed flexion contracture\> 15 degrees * patients with deformity greater than 20 degrees of varus or 15 degrees of valgus * Patient with Mediolateral stability \> 10 degrees patient with active or suspected malignancy * patient with Rheumatoid arthritis * patient with systemic disease that would effect subject's wellfare or overall outcome of the study * patient with other severe concurrent joint involvement which can effect their outcome * patients with an immobile hip * patient with a history of Pulmonary embolism or Deep venous thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| range of motion | pre-op vs post-op until 5 years post-op | measurement of flexion and extension in degrees |
| blood loss | 24 hours after surgery | measurement of milliliters blood loss during the first 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient questionnaire | pre-op vs post-op until 5 year post operative | WOMAC pain and function score |
| chair rise and stair climb test | pre-op vs post-op until 5 years post operative | Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities |
Outcome results
None listed