Hip NecrosisNEC15NCT04210440
The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression
A study testing Core decompression procedure in people with Hip Necrosis and Hip Injuries, run by Dante Dallari, MD at 1 site in Italy.
Trial summary
This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Necrosis, Hip Injuries
- What is being tested?
- Core decompression procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2003to 1 Mar 2012
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- hip avascular necrosis
Who cannot join
- protrusio acetabuli
- concentric femoral head migration;
- presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)
- presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);
- concomitant rheumatic diseases;
- bone tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Decompression With Bone Chips Allograft Adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS): Results in Avascular Necrosis of Femoral Head (AVN) After 2 Years Minimum Follow-up
This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).
Read the detailed description
We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).
The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year.
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR), while the secondary outcomes were the assessment of any change in clinical performance as measured by Harris Hip Score
- Conditions
- Hip Necrosis, Hip Injuries
- Being tested
- Core decompression procedure
- Keywords
- hip avascular necrosis, hip conservative surgery
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core decompression procedureProcedure or surgery
Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow
| Study group | Role | What they receive |
|---|---|---|
| Hip avascular necrosis | Experimental | patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria Receives: Procedure: Core decompression procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoiding arthroplasty
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)
Measured: 24 months after surgery
Secondary outcomes (4)
Harris Hip Score
The collection of functional outcomes score HHS at 6 weeks. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 6 weeks after surgery
Harris Hip Score
The collection of functional outcomes score HHS at 3 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results
Measured: 3 months after surgery
Harris Hip Score
The collection of functional outcomes score HHS at 6 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 6 months after surgery
Harris Hip Score
The collection of functional outcomes score HHS at 12 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Mar 2003
- Primary completion1 Mar 2011
- Study completion1 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip NecrosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dante Dallari, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dante Dallari, MD, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210440
- Sponsor's protocol ID
- 0029170
- Acronym
- NEC15
- Status last verified
- Dec 2019
- First submitted
- 21 Dec 2019
- Last updated
- 24 Dec 2019
- 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 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Decompression With Bone Chips Allograft Adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS): Results in Avascular Necrosis of Femoral Head (AVN) After 2 Years Minimum Follow-up
- ClinicalTrials.gov ID
- NCT04210440
- Acronym / sponsor ID
- NEC15 / 0029170
- Conditions
- Hip Necrosis, Hip Injuries
- Keywords
- hip avascular necrosis, hip conservative surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dante Dallari, MDUniversity, hospital or other
- Study start
- 1 Mar 2003 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 1 Mar 2012 (actual)
- First posted
- 24 Dec 2019 (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 retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).
Detailed description
We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).
The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year.
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR), while the secondary outcomes were the assessment of any change in clinical performance as measured by Harris Hip Score
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip avascular necrosis | Experimental | Procedure: Core decompression procedurepatients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- hip avascular necrosis
Key exclusion criteria (6 listed)
- protrusio acetabuli
- concentric femoral head migration;
- presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)
- presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);
- concomitant rheumatic diseases;
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 decompression procedureCore Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow | Procedure or surgery | Hip avascular necrosis |
Primary outcome
Avoiding arthroplasty
Time frame: 24 months after surgery
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)
4 secondary outcomes
Harris Hip Score
Time frame: 6 weeks after surgery
Harris Hip Score
Time frame: 3 months after surgery
Harris Hip Score
Time frame: 6 months after surgery
Harris Hip Score
Time frame: 12 months after surgery
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 24 Dec 2019.
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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 procedure in people with Hip Necrosis and Hip Injuries, run by Dante Dallari, MD at 1 site in Italy.
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 1 inclusion and 6 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 24 Dec 2019. 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 Italy. 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?
Avoiding arthroplasty (time frame: 24 months after surgery). 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 24 Dec 2019.