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OsteonecrosisPhase 3AVN-13NCT01892514

Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head

A Phase 3 study testing core decompression in people with Osteonecrosis, run by Istituto Ortopedico Rizzoli at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new United States of America cases) characterized by ischemic cell necrosis in a hip proximal epiphysis area frequently requiring total Hip Arthroplasty (THA). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Osteonecrosis
What is being tested?
core decompression
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
3 sitesItaly
Study dates
Apr 2013to Apr 2018
Phase
Phase 3
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with necrosis of the femoral head without fracture of the subchondral bone and without flattening of the head itself (according to ARCO classification 2A, B, C).
  • Age between 18 and 60 years.
  • Any etiology
  • Patients who had undergone a previous orthopaedic treatment for traumatology interventions

Who cannot join

  • Patients under the age of 18 years or more than 60 years.
  • Patients not able to provide informed consent to treatment.
  • Patients suffering from apparent local infective processes.
  • Patients with active neoplastic diseases.
  • Patients with necrosis of the femoral head of advanced stages (ARCO 3A, B, C, 4).
  • Pregnant patients

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • 3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute

    Bologna, 40136

  • S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute

    Bologna, 40136

  • Orthopaedic and Traumatologic Department Policlinico di Modena

    Modena, 41124

Other trials in Italy

About this study

Official title: Combined Treatment of Early and Advanced Osteonecrosis of the Femoral Head With Core Decompression and Grafting With Demineralized Bone Matrix (DBM) or Homologous Lyophilized Bone Chips (LBC) Together With Platelet-rich-fibrin (PRF) and Concentrated Bone Marrow (CBM)

Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new United States of America cases) characterized by ischemic cell necrosis in a hip proximal epiphysis area frequently requiring total Hip Arthroplasty (THA).

Even though THA resolves symptoms and restores good joint function, young patients are prone to major disabilities and require prosthesis revision surgeries.

Read more

In this clinical trial a comparison between two groups of patients, treated with the same procedure but with two different regenerative techniques, will be performed:

  1. 52 patients with necrosis in an early stage, without deformity of the femoral epiphysis (stage 2A-B-C in Association for Research on Osseous Circulation (ARCO) classification, will undergo wide decompression of the necrotic area and reconstruction with homologous Lyophilized Bone Chips (LBC), growth factors from platelet concentrate Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM).
  2. 52 patients with necrosis of similar features, without deformity of the femoral epiphysis, will undergo wide decompression of the necrotic area and reconstruction with Demineralized Bone Matrix (DBM), growth factors from Platelet-Rich-Fibrin (PRF) and Concentrated Bone Marrow (CBM).

Patients will be evaluated post-surgery at 6 weeks, 3, 6, 12, and 24 months to assess joint damage evolution by ARCO classification, and hip function by clinical scores (Harris Hip Score (HHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score, and Visual Analogic Scale (VAS)).

Read the detailed description

Rationale. In vitro study and animal models have shown that Mesenchymal Stromal Cells (MSC) have the capacity to differentiate into osteoblastic lineage and that platelet reach fibrin can represent a clinical source of growth factors, able to accelerate the processes of tissue repair. This study intend to highlight how these factors, associated to two different preparations of bone allograft, may accelerate the formation of new host bone in patients with osteonecrosis of the femoral head that represents a common condition in clinical practice with an high socio-economic impact.

Primary objective of the study is to delay or avoid total hip replacement in patients with early necrosis of the femoral head, using different methods of regenerative medicine.

Secondary end points are described below:

  • To assess differences in outcome related to features, etiology and localization of the necrosis of the femoral head and to assess variation in post-operative return to daily activities.
  • To characterize the osteogenetic and angiogenic potential of marrow-derived Mesenchymal Stromal Cells (MSC) in patients with avascular necrosis of the femoral head, and to correlate these features with medical history and clinical outcome.
Conditions
Osteonecrosis
Being tested
core decompression
Keywords
osteonecrosis, bone marrow concentrate, demineralized bone matrix, homologous lyophilized bone chips, autologous platelet rich fibrin, mesenchymal stromal cells
Medical subject headings
Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • core decompressionProcedure or surgery

    core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)

Study groups in NCT01892514
Study groupRoleWhat they receive
Demineralized Bone Marrow (DBM)Experimentalcore decompression of necrotic area and graft with a biological product based on Demineralized Bone Matrix (DBM), Platelet-Rich-Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Receives: Procedure: core decompression
Lyophilized Bone Chips (LBC)Experimentalcore decompression of the necrotic area and graft with a biological product based on homologous Lyophilized Bone Chips (LBC), Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Receives: Procedure: core decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI)

    Measured: baseline, and 12 months after surgery

Secondary outcomes (3)

  1. Pain reduction by measurement of the Visual Analog Scale (VAS)

    Measured: baseline, and 6 weeks, 3, 6, 12, 24 months after surgery

  2. Functional status evaluated by Harris Hip Score (HHS) and Western Ontario McMaster Universities Arthritis Index (WOMAC)

    Measured: baseline, and 6, 12, 24 months after surgery

  3. maintenance of structural integrity of the joint by Radiography (RX)

    Measured: baseline, and 6 weeks, 3, 6, 12, 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892514
Sponsor's protocol ID
AVN-13
Acronym
AVN-13
Status last verified
May 2023
First submitted
25 Jun 2013
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Dallari D, Fini M, Stagni C, Torricelli P, Nicoli Aldini N, Giavaresi G, Cenni E, Baldini N, Cenacchi A, Bassi A, Giardino R, Fornasari PM, Giunti A. In vivo study on the healing of bone defects treated with bone marrow stromal cells, platelet-rich plasma, and freeze-dried bone allografts, alone and in combination. J Orthop Res. 2006 May;24(5):877-88. doi: 10.1002/jor.20112.

    PubMed 16609976

  • Dallari D, Savarino L, Stagni C, Cenni E, Cenacchi A, Fornasari PM, Albisinni U, Rimondi E, Baldini N, Giunti A. Enhanced tibial osteotomy healing with use of bone grafts supplemented with platelet gel or platelet gel and bone marrow stromal cells. J Bone Joint Surg Am. 2007 Nov;89(11):2413-20. doi: 10.2106/JBJS.F.01026.

    PubMed 17974883

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing core decompression in people with Osteonecrosis, run by Istituto Ortopedico Rizzoli at 3 sites 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 4 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI) (time frame: baseline, and 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01892514, which also lists 2 linked publications.

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 12 May 2023.

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