Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration
Brief summary
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.
Interventions
PROCEDUREumbilical cord blood stem cell implantation for osteoarthritis treatment
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.
Sponsors
Uijeongbu St. Mary Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
only case series of the treated patients
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Cartilage Repair Society (ICRS) grade improvement | at 24, 48, 96 weeks after surgery, score changes will be observed. | over grade 1 should be improved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | at 24, 48, 96 weeks after surgery, score changes will be observed. | 0-10 score range, lower the better |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | at 24, 48, 96 weeks after surgery, score changes will be observed. | 0-100 score range, lower the better |
| International Knee Documentation Committee (IKDC score) | at 24, 48, 96 weeks after surgery, score changes will be observed. | 0-100 % range, lower the better |
Outcome results
None listed