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

June 12, 2023 updated by: Mahmoud Abdelgaliel Mohamed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cartilage regeneration
35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy
Procedure: cartilage regeneration technique
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu
Active Comparator: microfracture
35 patient will have knee arthroscopy and microfracture with high tibial osteotomy
Procedure: cartilage regeneration technique
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu
Placebo Comparator: high tibial osteotomy
35 patient will have knee arthroscopy and high tibial osteotomy
Procedure: cartilage regeneration technique
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical assessment of International Knee Documentation Committee (IKDC) scores
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGMM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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