Comparative analysis of bone union after high tibial osteotomy between bone marrow stromal cell with synthetic bone graft and without bone filler; randomized control trial
Phase 4
Active, not recruiting
- Conditions
- Deep infection in surgical wound of high tibial osteotomy required secondary operationBMAC, Open-wedged high tibial osteotomy, Medial compartment osteoarthritis
- Registration Number
- TCTR20240418002
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Patient age 50-65 years old with medial compartment osteoarthritis with varus deformity (KL grade II-III) and failed conservative at least 3 months
Exclusion Criteria
1. Inflammatory joint disease Ex. RA, Gout, Pseudogout
2. Patellofemoral arthritis
3. Patients who had history of fracture around knee or septic arthritis
4. Patients who had flexion contracture more and equal than 15 degree or Patient who can flex knee less than 90 degree
5. Patients who should correct deformity more than 20 degree
6. Patients who can't continue follow up or long term follow up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compared of percent of bone union at 3 months after surgery between HTO with BMAC and synthetic bone graft and HTO without bone filler 3 months Fisher exact test
- Secondary Outcome Measures
Name Time Method Compared of HKA, FTA, mMPTA, PTS before and after surgery between HTO with BMAC and synthetic bone graft and HTO without bone filler 3, 6, 12 months Student t-test and Man-Whitney test,Compared of percent of bone union at 6 months after surgery between HTO with BMAC and synthetic bone graft and HTO without bone filler 6 months Fisher Exact test