Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
Phase 4
Completed
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT02625311
- Lead Sponsor
- Maastricht University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method blood loss 24 hours after surgery measurement of milliliters blood loss during the first 24 hours after surgery
range of motion pre-op vs post-op until 5 years post-op measurement of flexion and extension in degrees
- Secondary Outcome Measures
Name Time Method 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
patient questionnaire pre-op vs post-op until 5 year post operative WOMAC pain and function score