NCT02642848

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

December 11, 2015

Last Update Submit

January 1, 2016

Conditions

OsteoarthritisGenu Varum

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

HTO with micro fracture

ACTIVE COMPARATOR

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

HTO with bone marrow stem cell

EXPERIMENTAL

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

Procedure: HTO with microfractureProcedure: Transplantation of bone marrow stem cell

HTO with adipose derived stem cell

EXPERIMENTAL

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

Procedure: HTO with microfractureProcedure: Transplantation of adipose derived stem cell

Interventions

HTO with microfracturePROCEDURE

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

HTO with adipose derived stem cellHTO with bone marrow stem cellHTO with micro fracture
Transplantation of bone marrow stem cellPROCEDURE

Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc

HTO with bone marrow stem cell
Transplantation of adipose derived stem cellPROCEDURE

Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc

HTO with adipose derived stem cell

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International St. Mary's Hospital

Incheon, Incheon, 22711, South Korea

RECRUITING

MeSH Terms

Conditions

OsteoarthritisGenu Varum

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone Diseases

Central Study Contacts

Dongsik Chae

CONTACT

82-32-290-3151drchaeos@gmail.com

Jeong-min Shin

CONTACT

82-32-290-3158kook4731@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 11, 2015

First Posted

December 30, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

KR(1)