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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2025-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cartilage regeneration

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

Group Type ACTIVE_COMPARATOR

cartilage regeneration technique

Intervention Type PROCEDURE

autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

microfracture

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

Group Type ACTIVE_COMPARATOR

cartilage regeneration technique

Intervention Type PROCEDURE

autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

high tibial osteotomy

35 patient will have knee arthroscopy and high tibial osteotomy

Group Type PLACEBO_COMPARATOR

cartilage regeneration technique

Intervention Type PROCEDURE

autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

Interventions

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cartilage regeneration technique

autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes