Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects

Knee Osteoarthritis Clinical Trial

Official title:

Comparative Study Between Autologous Adipose Tissue Graft With Hyaline Catilage Versus Microfracture for Treatment of Articular Cartilage Defects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05912998
• Other study ID #: MGMM
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Knee arthroscopy using standard portals will be performed in three groups. Complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. The cartilage lesion grading according to the International Cartilage Repair Society system (ICRS). The patients assigned for the first group will have Liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). Autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. The graft will be mixed with fibrin glue and left to solidify a little. After obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. During the graft preparation, a high tibial osteotomy will be performed. Patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. Patients assigned for the third group will have open wedge high tibial osteotomy. Standard titanium T locked plate will be used to fix the open wedge osteotomy in the three groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age group 18 to 60 years old.

• Cartilage defect size range 2-5 cm2.

• Outer Bridge classification II & III.

• Single full thickness symptomatic femoral condyles ulcer.

• Varus deformity of the affected knee 50 - 100.

Exclusion Criteria:

• Advanced knee osteoarthritis.

• Knee range of motion less than 1000.

• Ligamentous injury of the affected knee.

• Recent intra articular injection of any type with in last 6 months.

• Fracture around the knee.

• Inflammatory joints disorders.

• Tumors.

• Immunocompromised patients.

• Body mass index < 35

• Valgus deformed knee any degree

• Sever varus deformed knee < 10 0

Related Conditions & MeSH terms

• Fractures, Stress
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• cartilage regeneration technique
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment of International Knee Documentation Committee (IKDC) scores		one year