Back to resultsComparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects
Primary Purpose
Knee Osteoarthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cartilage regeneration technique
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
cartilage regeneration
microfracture
high tibial osteotomy
Arm Description
35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy
35 patient will have knee arthroscopy and microfracture with high tibial osteotomy
35 patient will have knee arthroscopy and high tibial osteotomy
Outcomes
Primary Outcome Measures
Clinical assessment of International Knee Documentation Committee (IKDC) scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05912998
Brief Title
Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects
Official Title
Comparative Study Between Autologous Adipose Tissue Graft With Hyaline Catilage Versus Microfracture for Treatment of Articular Cartilage Defects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cartilage regeneration
Arm Type
Active Comparator
Arm Description
35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy
Arm Title
microfracture
Arm Type
Active Comparator
Arm Description
35 patient will have knee arthroscopy and microfracture with high tibial osteotomy
Arm Title
high tibial osteotomy
Arm Type
Placebo Comparator
Arm Description
35 patient will have knee arthroscopy and high tibial osteotomy
Intervention Type
Procedure
Intervention Name(s)
cartilage regeneration technique
Intervention Description
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu
Primary Outcome Measure Information:
Title
Clinical assessment of International Knee Documentation Committee (IKDC) scores
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects
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