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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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240418002
Enrollment
28
Registered
2024-04-18
Start date
2023-12-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep infection in surgical wound of high tibial osteotomy required secondary operation BMAC, Open-wedged high tibial osteotomy, Medial compartment osteoarthritis

Interventions

We will perform open gap osteotomy at proximal tibia and fixation with medial high tibial osteotomy locking plate (Tomofix). If patient in BMAC and synthetic bone graft insertion group. we will harves
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Patient who had open-wedge high tibial osteotomy with BMAC and synthetic bone graft,Patient who had open-wedge high tibial osteotomy without bone filler

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
50 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPatchara Sengpanich

Lerdsin hospital

patchara.sengpanich@gmail.com0882601193

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026