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Clinical Trials/NCT02642848
NCT02642848
Unknown
Not Applicable

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

Dongsik Chae1 site in 1 country52 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Dongsik Chae
Enrollment
52
Locations
1
Primary Endpoint
Knee score
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dongsik Chae
Responsible Party
Sponsor Investigator
Principal Investigator

Dongsik Chae

Assistant professor

Catholic Kwandong University

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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