NCT02625311CompletedPhase 4
A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
Maastricht University Medical Center0 sites69 target enrollmentStarted: December 1, 2004Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 69
- Primary Endpoint
- blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MIS
Experimental
Minimal invasive surgery for placement total knee prosthesis
Intervention: surgery method using CR TKP (Procedure)
conventional approach
Active Comparator
conventional "open" surgery for placement total knee prosthesis.
Intervention: surgery method using CR TKP (Procedure)
Outcomes
Primary Outcomes
blood loss
Time Frame: 24 hours after surgery
measurement of milliliters blood loss during the first 24 hours after surgery
range of motion
Time Frame: pre-op vs post-op until 5 years post-op
measurement of flexion and extension in degrees
Secondary Outcomes
- chair rise and stair climb test(pre-op vs post-op until 5 years post operative)
- patient questionnaire(pre-op vs post-op until 5 year post operative)
Investigators
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