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

Primary Purpose

Osteoarthritis, Genu Varum

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HTO with microfracture
Transplantation of bone marrow stem cell
Transplantation of adipose derived stem cell
Sponsored by
Dongsik Chae
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • International St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

HTO with micro fracture

HTO with bone marrow stem cell

HTO with adipose derived stem cell

Arm Description

High tibial osteotomy(HTO) with micro fracture is an common treatment for the correction of malalignment of the knee treating osteoarthritis.

High tibial osteotomy(HTO) with transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone.

High tibial osteotomy(HTO) with autologous adipose-derived stromal vascular fraction transplantation using LipoSculptor collecting from abdominal fat tissue.

Outcomes

Primary Outcome Measures

Knee score
MRI
Using MRI, evaluate cartilage conditions by ICRS grade
Arthroscopic finding
Using arthroscopy, evaluate degree of cartilage repair

Secondary Outcome Measures

Full Information

First Posted
December 11, 2015
Last Updated
January 1, 2016
Sponsor
Dongsik Chae
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1. Study Identification

Unique Protocol Identification Number
NCT02642848
Brief Title
Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy
Acronym
HTOSC
Official Title
Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dongsik Chae

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Genu Varum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HTO with micro fracture
Arm Type
Active Comparator
Arm Description
High tibial osteotomy(HTO) with micro fracture is an common treatment for the correction of malalignment of the knee treating osteoarthritis.
Arm Title
HTO with bone marrow stem cell
Arm Type
Experimental
Arm Description
High tibial osteotomy(HTO) with transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone.
Arm Title
HTO with adipose derived stem cell
Arm Type
Experimental
Arm Description
High tibial osteotomy(HTO) with autologous adipose-derived stromal vascular fraction transplantation using LipoSculptor collecting from abdominal fat tissue.
Intervention Type
Procedure
Intervention Name(s)
HTO with microfracture
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Transplantation of bone marrow stem cell
Intervention Description
Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc
Intervention Type
Procedure
Intervention Name(s)
Transplantation of adipose derived stem cell
Intervention Description
Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc
Primary Outcome Measure Information:
Title
Knee score
Time Frame
one year
Title
MRI
Description
Using MRI, evaluate cartilage conditions by ICRS grade
Time Frame
One year
Title
Arthroscopic finding
Description
Using arthroscopy, evaluate degree of cartilage repair
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsik Chae
Phone
82-32-290-3151
Email
drchaeos@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-min Shin
Phone
82-32-290-3158
Email
kook4731@naver.com
Facility Information:
Facility Name
International St. Mary's Hospital
City
Incheon
ZIP/Postal Code
22711
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-min Shin
Phone
82-32-290-3158

12. IPD Sharing Statement

Learn more about this trial

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

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