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

NCT05912998 | Unknown

• 1 other identifier: MGMM
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of International Knee Documentation Committee (IKDC) scores

  one year

Study Arms (3)

cartilage regeneration

ACTIVE COMPARATOR

35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy

Procedure: cartilage regeneration technique

microfracture

ACTIVE COMPARATOR

35 patient will have knee arthroscopy and microfracture with high tibial osteotomy

Procedure: cartilage regeneration technique

high tibial osteotomy

PLACEBO COMPARATOR

35 patient will have knee arthroscopy and high tibial osteotomy

Procedure: cartilage regeneration technique

Interventions

cartilage regeneration technique PROCEDURE

autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

cartilage regeneration; high tibial osteotomy; microfracture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 15, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06