Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy

Study Overview
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Brief Summary
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The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as conventional microfracture surgery on injured cartilage has a disadvantage of the replacement by fibrocartilage, this research intends to prove the excellence over the conventional therapy by proving a hyaline cartilage regeneration of injured cartilage by stem cell.

Detailed Description
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The prevalence rate of arthritis in medial knee joint is increasing with an increase in senile diseases and there are two main types of therapy: total knee replacement surgery and high tibial osteotomy. Generally, the elderly prefer total knee replacement surgery and younger people prefer high tibial osteotomy. High tibial osteotomy is a procedure to reduce pain and to prevent the progression of osteoarthritis by evenly dispersing excessive load on medial knee joint attributed to varus deformity on the overall knee joint through the correction of abnormal anatomical axis arising from degenerative changes in articular cartilage. The clinical outcomes of high tibial osteotomy are reported as favorable but this high tibial osteotomy has a limitation in terms of the regeneration of injured cartilage. Thus, a research to concurrently perform additional therapy for the regeneration of injured cartilage with the osteotomy was released. Microfracture surgery on injured cartilage, autologous chondrocyte implantation, autologous bone marrow injections and adipose derived stem cell injections are typical examples. However, there is not any solid proof for the excellence of concurrent therapy over a therapy using only the osteotomy in the regeneration of injured cartilage. Therefore, this research is designed to conduct a research to prove the excellence of the direct transplantation of stem cell into injured cartilage over the existing concurrent therapy in the regeneration of injured cartilage. Besides, this research intends to compare the cartilage regeneration capabilities of bone marrow and adipose-derived stem cell.

Official Title
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Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy

Conditions
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Osteoarthritis, Genu Varum

Intervention / Treatment
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* Procedure: HTO with microfracture
* Procedure: Transplantation of bone marrow stem cell
* Procedure: Transplantation of adipose derived stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 or more to 65 years of age or younger Classification of degenerative arthritis: Kellgren-Lawrence grade I, III, III Arthritis lesion limited to medial knee joint Varus deformity of knee joint of 15 degrees or less BMI under 35 Exclusion Criteria: More than 65 years of age Classification of degenerative arthritis: Kellgren-Lawrence grade IV Lesions of arthritis (Kellgren-Lawrence grade III, IV) found in lateral knee joint Varus deformity of knee joint more than 15 degrees BMI above 35 Operation history - Surgery of Microfracture and fracture, and ligament regeneration History of intraarticular injection of steroid and hyaluronic acid in the last 3 months

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HTO with micro fracture<br>High tibial osteotomy(HTO) with micro fracture is an common treatment for the correction of malalignment of the knee treating osteoarthritis. | Procedure: HTO with microfracture<br>* High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix<br>|
| Experimental: HTO with bone marrow stem cell<br>High tibial osteotomy(HTO) with transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. | Procedure: HTO with microfracture<br>* High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix<br>Procedure: Transplantation of bone marrow stem cell<br>* Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc<br>|
| Experimental: HTO with adipose derived stem cell<br>High tibial osteotomy(HTO) with autologous adipose-derived stromal vascular fraction transplantation using LipoSculptor collecting from abdominal fat tissue. | Procedure: HTO with microfracture<br>* High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix<br>Procedure: Transplantation of adipose derived stem cell<br>* Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee score |  | one year | 
| MRI | Using MRI, evaluate cartilage conditions by ICRS grade | One year | 
| Arthroscopic finding | Using arthroscopy, evaluate degree of cartilage repair | One year |