Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

Uijeongbu St. Mary Hospital10 enrolled

Overview

The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint. Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

The arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl. Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age older than 30 years, * full-thickness cartilage lesion measuring at least 2 cm2, * femoro-tibial angle (varus or valgus) 5°\< in the mechanical axis Exclusion Criteria: * ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament), * metabolic arthritis * infectious condition * psychosis * serious medical illness * pregnancy

Outcomes

Primary Outcomes

International Cartilage Repair Society (ICRS) grade improvement

over grade 1 should be improved

Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.

Secondary Outcomes

Visual analogue scale (VAS)

0-10 score range, lower the better

Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

0-100 score range, lower the better

Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.

International Knee Documentation Committee (IKDC score)

0-100 % range, lower the better

Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.