Avascular Necrosis of the Femoral HeadNCT07922551
Core Decompression Versus Core Decompression With Platelet-Rich Plasma Instillation for Treatment of Early Stage Avascular Necrosis of Femoral Head
A study testing Core Decompression and Platelet rich plasma (PRP) in people with Avascular Necrosis of the Femoral Head, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare core decompression, a classic technique used for the treatment of avascular necrosis of the femoral head, versus core decompression augmented with PRP instillation, and how it affects the outcome of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis of the Femoral Head
- What is being tested?
- Core Decompression and Platelet rich plasma (PRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2022to 22 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females.
- Age greater-than 18 years old.
- Patients diagnosed with unilateral or bilateral avascular necrosis of the femoral head presenting in the pre-collapse phase, Arlet and Ficat stage I and II.
- Patients who agree to participate in the study and signed an informed consent.
Who cannot join
- AVNFH with Arlet and Ficat stage III, and IV
- Patients not willing to participate or refused to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine - Ain Shams University
Abbassia, Cairo Governorate, 00202
About this study
This study aims to compare core decompression, a classic technique used for the treatment of avascular necrosis of the femoral head, versus core decompression augmented with PRP instillation, and how it affects the outcome of the disease.
Read the detailed description
A total of 30 hips with stage 1 or 2 avascular necrosis of the femoral head according to the Arlet and Ficat classification were included in the study. Using randomized allocation, 15 hips underwent core decompression alone and 15 hips underwent core decompression with Platelet-Rich-Plasma instillation.
- Conditions
- Avascular Necrosis of the Femoral Head
- Being tested
- Core Decompression, Platelet rich plasma (PRP)
- Keywords
- Core Decompression, PRP, Platelet Rich Plasma, AVN Femoral Head, Avascular Necrosis of the Femoral Head
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core DecompressionProcedure or surgery
The classic technique used to manage these types of cases
Platelet rich plasma (PRP)Biological
Augmenting Core Decompression with PRP instillation as a biological enhancement to a classic technique
| Study group | Role | What they receive |
|---|---|---|
| Core Decompression | Active comparator | This is the classic gold standard technique used for these types of patients Receives: Procedure: Core Decompression |
| Core Decompression with PRP Instillation | Experimental | This is an augmented form of core decompression which includes a biological enhancement by adding PRP instillation Receives: Procedure: Core Decompression; Biological: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
A numerical assessment measurement of hip function and pain on a scale of 0-100
Measured: 18 months post intervention
Secondary outcomes (2)
Modified Kerboul Angle
A radiological assessement measurement of femoral head necrosis by measuring angles from serial MRI scans.
Measured: 18 months post intervention
Conversion to Total Hip Arthroplasty
A real world indicator of joint preservation showing whether patients were satisfied with the outcome or had to resort to hip replacement surgery.
Measured: 18 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start25 Oct 2022
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of the Femoral HeadStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922551
- Sponsor's protocol ID
- MD242/2022
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Decompression Versus Core Decompression With Platelet-Rich Plasma Instillation for Treatment of Early Stage Avascular Necrosis of Femoral Head
- ClinicalTrials.gov ID
- NCT07922551
- Acronym / sponsor ID
- MD242/2022
- Conditions
- Avascular Necrosis of the Femoral Head
- Keywords
- Core Decompression, PRP, Platelet Rich Plasma, AVN Femoral Head, Avascular Necrosis of the Femoral Head
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 6 Nov 2026 (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.
This study aims to compare core decompression, a classic technique used for the treatment of avascular necrosis of the femoral head, versus core decompression augmented with PRP instillation, and how it affects the outcome of the disease.
Detailed description
A total of 30 hips with stage 1 or 2 avascular necrosis of the femoral head according to the Arlet and Ficat classification were included in the study. Using randomized allocation, 15 hips underwent core decompression alone and 15 hips underwent core decompression with Platelet-Rich-Plasma instillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Decompression | Active comparator | Procedure: Core DecompressionThis is the classic gold standard technique used for these types of patients |
| Core Decompression with PRP Instillation | Experimental | Procedure: Core Decompression, Biological: Platelet rich plasma (PRP)This is an augmented form of core decompression which includes a biological enhancement by adding PRP instillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females.
- Age greater-than 18 years old.
- Patients diagnosed with unilateral or bilateral avascular necrosis of the femoral head presenting in the pre-collapse phase, Arlet and Ficat stage I and II.
- Patients who agree to participate in the study and signed an informed consent.
Key exclusion criteria (2 listed)
- AVNFH with Arlet and Ficat stage III, and IV
- Patients not willing to participate or refused to sign an informed consent.
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 |
|---|---|---|
| Core DecompressionThe classic technique used to manage these types of cases | Procedure or surgery | Core Decompression, Core Decompression with PRP Instillation |
| Platelet rich plasma (PRP)Augmenting Core Decompression with PRP instillation as a biological enhancement to a classic technique | Biological | Core Decompression with PRP Instillation |
Primary outcome
Harris Hip Score
Time frame: 18 months post intervention
A numerical assessment measurement of hip function and pain on a scale of 0-100
2 secondary outcomes
Modified Kerboul Angle
Time frame: 18 months post intervention
Conversion to Total Hip Arthroplasty
Time frame: 18 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Decompression and Platelet rich plasma (PRP) in people with Avascular Necrosis of the Femoral Head, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Harris Hip Score (time frame: 18 months post intervention). 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 6 Nov 2026.