Ankle OsteoarthritisNCT04883892
Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis
A study testing BMAC and HA in people with Ankle Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- BMAC and HA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2021to 11 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with degenerative ankle cartilage disease;
- Unilateral involvement on the ankle;
- Signs and symptoms of degenerative pathology of the ankle cartilage;
- Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
- No clinically significant electrocardiographic changes (recently performed ECG).
- Ability and consent of patients to actively participate in clinical follow-up;
Who cannot join
- Patients unable to give consent;
- Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
- Patients who have undergone ankle surgery in the preceding 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with uncompensated diabetes;
- 9. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index > 35;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. After 12 months patients in the control group can decide to cross-over in the treatment group.
Read the detailed description
All the patients who meet the inclusion criteria and giving written informed consent will be randomized. We planned to enrol 120 patients.
Following the randomization, every patient will be treated with a single injection of Bone Marrow Aspirate Concentrate (BMAC) or two injections of Hyaluronic Acid (HA) in the affected ankle.
After the treatment patients will be followed up to 24 months whit clinical and radiological assessment.
After 12 months patients in the control group can decide to cross-over in the treatment group with BMAC. These patients will be followed up further 12 months.
- Conditions
- Ankle Osteoarthritis
- Being tested
- BMAC, HA
- Keywords
- bone marrow aspirate concentrate, hyaluronic acid, BMAC, HA, ankle, ankle injection, ankle OA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMACProcedure or surgery
Also called Bone Marrow Aspirate Concentrate injection
patients will be injected with BMAC into the ankle joint, after treatment patients will be followed up to 24 months. In particular patients will be assessed after treatment at 1, 3, 6, 12 and 24 months.
During the injection, samples of BMAC will be collected for the characterization of the phenotype markers and clonogenic capability
HAProcedure or surgery
Also called Hyaluronic Acid injections
patients will be treated with two injection of HA, one every 15 days, into the ankle joint. After treatment these patients will be followed up to 24 months. At 12 months patients can decide to cross.over in the BMAC arm treatment. After cross-over patients will be assessed for further 12 months.
| Study group | Role | What they receive |
|---|---|---|
| BMAC injection | Experimental | Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint Receives: Procedure: BMAC |
| HA injections | Active comparator | two injections of Hyaluronic Acid (HA) into the ankle joint - one injection every 15 days.
After 12 months patients are allowed to cross-over in the BMAC arm. Receives: Procedure: HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOS (Ankle Osteoarthritis Scale)
Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment
Measured: Baseline, 1, 3, 6, 12, 24 months
Secondary outcomes (1)
AOFAS (The American Orthopedic Foot and Ankle Score)
Score 0-100 made by 3 categories: Pain (0-40), Function (0-50) and Alignment (0-10).
The best clinical and function condition is represented by a score of 100. 0 is the worst possible condition.
Measured: Baseline, 1, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 Dec 2021
- Primary completion15 Jun 2022
- Study completion11 Aug 2025
Why it stopped: Issues related to the adaptation of BMAC kits to the MDR
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Crossover
- Model description
- RCT, single-blind, allocation 1:1. After 12 months patients in the control group are allowed to cross-over in the treatment group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883892
- Sponsor's protocol ID
- BMAC
- Status last verified
- Aug 2025
- First submitted
- 7 May 2021
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.
PubMed 27566242Kennedy JG, Murawski CD. The Treatment of Osteochondral Lesions of the Talus with Autologous Osteochondral Transplantation and Bone Marrow Aspirate Concentrate: Surgical Technique. Cartilage. 2011 Oct;2(4):327-36. doi: 10.1177/1947603511400726.
PubMed 26069591Giannini S, Buda R, Cavallo M, Ruffilli A, Cenacchi A, Cavallo C, Vannini F. Cartilage repair evolution in post-traumatic osteochondral lesions of the talus: from open field autologous chondrocyte to bone-marrow-derived cells transplantation. Injury. 2010 Nov;41(11):1196-203. doi: 10.1016/j.injury.2010.09.028. Epub 2010 Oct 8.
PubMed 20934692Buda R, Vannini F, Castagnini F, Cavallo M, Ruffilli A, Ramponi L, Pagliazzi G, Giannini S. Regenerative treatment in osteochondral lesions of the talus: autologous chondrocyte implantation versus one-step bone marrow derived cells transplantation. Int Orthop. 2015 May;39(5):893-900. doi: 10.1007/s00264-015-2685-y. Epub 2015 Feb 8.
PubMed 25662594Vannini F, Cavallo M, Ramponi L, Castagnini F, Massimi S, Giannini S, Buda RE. Return to Sports After Bone Marrow-Derived Cell Transplantation for Osteochondral Lesions of the Talus. Cartilage. 2017 Jan;8(1):80-87. doi: 10.1177/1947603516642574. Epub 2016 Apr 12.
PubMed 27994723Luciani D, Cadossi M, Tesei F, Chiarello E, Giannini S. Viscosupplementation for grade II osteoarthritis of the ankle: a prospective study at 18 months' follow-up. Chir Organi Mov. 2008 Dec;92(3):155-60. doi: 10.1007/s12306-008-0066-z. Epub 2008 Dec 6.
PubMed 19067120
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04883892
- Acronym / sponsor ID
- BMAC
- Conditions
- Ankle Osteoarthritis
- Keywords
- bone marrow aspirate concentrate, hyaluronic acid, BMAC, HA, ankle, ankle injection, ankle OA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues related to the adaptation of BMAC kits to the MDR
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 12 May 2021 (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.
The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. After 12 months patients in the control group can decide to cross-over in the treatment group.
Detailed description
All the patients who meet the inclusion criteria and giving written informed consent will be randomized. We planned to enrol 120 patients.
Following the randomization, every patient will be treated with a single injection of Bone Marrow Aspirate Concentrate (BMAC) or two injections of Hyaluronic Acid (HA) in the affected ankle.
After the treatment patients will be followed up to 24 months whit clinical and radiological assessment.
After 12 months patients in the control group can decide to cross-over in the treatment group with BMAC. These patients will be followed up further 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT, single-blind, allocation 1:1. After 12 months patients in the control group are allowed to cross-over in the treatment group
| Arm | Type | Receives |
|---|---|---|
| BMAC injection | Experimental | Procedure: BMACSingle injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint |
| HA injections | Active comparator | Procedure: HAtwo injections of Hyaluronic Acid (HA) into the ankle joint - one injection every 15 days. After 12 months patients are allowed to cross-over in the BMAC arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with degenerative ankle cartilage disease;
- Unilateral involvement on the ankle;
- Signs and symptoms of degenerative pathology of the ankle cartilage;
- Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
- No clinically significant electrocardiographic changes (recently performed ECG).
Key exclusion criteria (7 listed)
- Patients unable to give consent;
- Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
- Patients who have undergone ankle surgery in the preceding 12 months;
- Patients with malignant neoplasms;
- Patients with 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 |
|---|---|---|
| BMACAlso: Bone Marrow Aspirate Concentrate injectionpatients will be injected with BMAC into the ankle joint, after treatment patients will be followed up to 24 months. In particular patients will be assessed after treatment at 1, 3, 6, 12 and 24 months. During the injection, samples of BMAC will be collected for the characterization of the phenotype markers and clonogenic capability | Procedure or surgery | BMAC injection |
| HAAlso: Hyaluronic Acid injectionspatients will be treated with two injection of HA, one every 15 days, into the ankle joint. After treatment these patients will be followed up to 24 months. At 12 months patients can decide to cross.over in the BMAC arm treatment. After cross-over patients will be assessed for further 12 months. | Procedure or surgery | HA injections |
Primary outcome
AOS (Ankle Osteoarthritis Scale)
Time frame: Baseline, 1, 3, 6, 12, 24 months
Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment
1 secondary outcome
AOFAS (The American Orthopedic Foot and Ankle Score)
Time frame: Baseline, 1, 3, 6, 12, 24 months
Results and safety
The study was stopped early (reason given: Issues related to the adaptation of BMAC kits to the MDR). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 27566242Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.
- Background: PubMed 26069591Kennedy JG, Murawski CD. The Treatment of Osteochondral Lesions of the Talus with Autologous Osteochondral Transplantation and Bone Marrow Aspirate Concentrate: Surgical Technique. Cartilage. 2011 Oct;2(4):327-36. doi: 10.1177/1947603511400726.
- Background: PubMed 20934692Giannini S, Buda R, Cavallo M, Ruffilli A, Cenacchi A, Cavallo C, Vannini F. Cartilage repair evolution in post-traumatic osteochondral lesions of the talus: from open field autologous chondrocyte to bone-marrow-derived cells transplantation. Injury. 2010 Nov;41(11):1196-203. doi: 10.1016/j.injury.2010.09.028. Epub 2010 Oct 8.
- Background: PubMed 25662594Buda R, Vannini F, Castagnini F, Cavallo M, Ruffilli A, Ramponi L, Pagliazzi G, Giannini S. Regenerative treatment in osteochondral lesions of the talus: autologous chondrocyte implantation versus one-step bone marrow derived cells transplantation. Int Orthop. 2015 May;39(5):893-900. doi: 10.1007/s00264-015-2685-y. Epub 2015 Feb 8.
- Background: PubMed 27994723Vannini F, Cavallo M, Ramponi L, Castagnini F, Massimi S, Giannini S, Buda RE. Return to Sports After Bone Marrow-Derived Cell Transplantation for Osteochondral Lesions of the Talus. Cartilage. 2017 Jan;8(1):80-87. doi: 10.1177/1947603516642574. Epub 2016 Apr 12.
- Background: PubMed 19067120Luciani D, Cadossi M, Tesei F, Chiarello E, Giannini S. Viscosupplementation for grade II osteoarthritis of the ankle: a prospective study at 18 months' follow-up. Chir Organi Mov. 2008 Dec;92(3):155-60. doi: 10.1007/s12306-008-0066-z. Epub 2008 Dec 6.
- Individual participant dataSharing planned: No
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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 BMAC and HA in people with Ankle Osteoarthritis, run by Istituto Ortopedico Rizzoli 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Aug 2025. 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 was stopped early (reason given: Issues related to the adaptation of BMAC kits to the MDR). 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?
AOS (Ankle Osteoarthritis Scale) (time frame: Baseline, 1, 3, 6, 12, 24 months). 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 NCT04883892, which also lists 6 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 17 Aug 2025.