Knee OsteoarthritisNCT05912998
Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects
A study testing cartilage regeneration technique in people with Knee Osteoarthritis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- cartilage regeneration technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Tumors.
- Immunocompromised patients.
- Body mass index < 35
- Valgus deformed knee any degree
- Sever varus deformed knee < 10 0
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- cartilage regeneration technique
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cartilage regeneration techniqueProcedure or surgery
autologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu
| Study group | Role | What they receive |
|---|---|---|
| cartilage regeneration | Active comparator | 35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy Receives: Procedure: cartilage regeneration technique |
| microfracture | Active comparator | 35 patient will have knee arthroscopy and microfracture with high tibial osteotomy Receives: Procedure: cartilage regeneration technique |
| high tibial osteotomy | Placebo comparator | 35 patient will have knee arthroscopy and high tibial osteotomy Receives: Procedure: cartilage regeneration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of International Knee Documentation Committee (IKDC) scores
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelgaliel Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912998
- Sponsor's protocol ID
- MGMM
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Autologous Adipose Tissue Graft With Hyaline Catilage Versus Microfracture for Treatment of Articular Cartilage Defects
- ClinicalTrials.gov ID
- NCT05912998
- Acronym / sponsor ID
- MGMM
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cartilage regeneration | Active comparator | Procedure: cartilage regeneration technique35 patient will have knee arthroscopy and cartilage regeneration technique and high tibial osteotomy |
| microfracture | Active comparator | Procedure: cartilage regeneration technique35 patient will have knee arthroscopy and microfracture with high tibial osteotomy |
| high tibial osteotomy | Placebo comparator | Procedure: cartilage regeneration technique35 patient will have knee arthroscopy and high tibial osteotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cartilage regeneration techniqueautologous adipose tissue graft with hyaline cartilage graft mixed with fiberinglu | Procedure or surgery | cartilage regeneration, high tibial osteotomy, microfracture |
Primary outcome
Clinical assessment of International Knee Documentation Committee (IKDC) scores
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cartilage regeneration technique in people with Knee Osteoarthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of International Knee Documentation Committee (IKDC) scores (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.