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

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ClinicalTrials.gov Identifier: NCT02642848
Recruitment Status : Unknown
Verified January 2016 by Dongsik Chae, Catholic Kwandong University.
Recruitment status was:  Recruiting
First Posted : December 30, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Dongsik Chae, Catholic Kwandong University

Tracking Information
First Submitted Date  ICMJE December 11, 2015
First Posted Date  ICMJE December 30, 2015
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2015)
  • Knee score [ Time Frame: one year ]
  • MRI [ Time Frame: One year ]
    Using MRI, evaluate cartilage conditions by ICRS grade
  • Arthroscopic finding [ Time Frame: One year ]
    Using arthroscopy, evaluate degree of cartilage repair
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02642848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy
Official Title  ICMJE Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Genu Varum
Intervention  ICMJE
  • Procedure: HTO with microfracture
    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
  • Procedure: Transplantation of bone marrow stem cell
    Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc
  • Procedure: Transplantation of adipose derived stem cell
    Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc
Study Arms  ICMJE
  • Active Comparator: HTO with micro fracture
    High tibial osteotomy(HTO) with micro fracture is an common treatment for the correction of malalignment of the knee treating osteoarthritis.
    Intervention: Procedure: HTO with microfracture
  • Experimental: HTO with bone marrow stem cell
    High tibial osteotomy(HTO) with transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone.
    Interventions:
    • Procedure: HTO with microfracture
    • Procedure: Transplantation of bone marrow stem cell
  • Experimental: HTO with adipose derived stem cell
    High tibial osteotomy(HTO) with autologous adipose-derived stromal vascular fraction transplantation using LipoSculptor collecting from abdominal fat tissue.
    Interventions:
    • Procedure: HTO with microfracture
    • Procedure: Transplantation of adipose derived stem cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 27, 2015)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02642848
Other Study ID Numbers  ICMJE IS15OISI0021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dongsik Chae, Catholic Kwandong University
Study Sponsor  ICMJE Dongsik Chae
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catholic Kwandong University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP