Knee OsteoarthritisNCT06164899
Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid
An observational study of Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This is a prospective observational study for long-term clinical evaluation (minimum 4-year follow-up) in patients treated within the research protocol "OA-bi-blind" (Double-blind randomized trial on the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Feb 2024to 12 Feb 2025
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research Protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute
Who may be able to join
- -Patients undergoing injection for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute.
- Who met the following criteria at the time of treatment:
- Male or female patients, aged 18 to 75 years;
- Symptomatic bilateral knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- Failure after at least 2 months of conservative treatment;
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinic and radiological follow-up; And who meet the following criteria at the time of assessment by telephone or via telemedicine platform;
Show all 9Show fewer
- Capable patients
- Signature of informed consent
- Availability
Who cannot join
- Patients no longer on call;
- Patients who do not agree to undergo evaluation
- Patients who have passed away.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid for the Treatment of Bilateral Knee Osteoarthritis. Prospective Observational Study
This is a prospective observational study for long-term clinical evaluation (minimum 4-year follow-up) in patients treated within the research protocol "OA-bi-blind" (Double-blind randomized trial on the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid)
Read the detailed description
60 patients treated within the "OA-bi-blind" research protocol from 2016 to 2019 at the II Orthopaedic and Trauma Clinic of the Rizzoli Orthopaedic Institute will be recruited. These are patients undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol.Prior to enrollment, patients will be contacted provided they have released their personal or legal guardian's e-mail address and/or personal or legal guardian's telephone number in advance and only after verifying the patient's consent to be contacted again for research purposes. If the patient is interested in participating in the study, arrangements will be made with him or her to send the Informed Consent and Disclosure Letter.
The patient will have to return (by means of a pre-stamped envelope that he will have received together with the consent itself) the Informed Consent completed in all its parts to the address given in the information letter. Only upon obtaining the fully completed Informed Consent may the investigator subject the patient to a telephone interview.
Alternatively, the patient may receive the Informed Consent and the questionnaire for clinical evaluations digitally.Clinical score data will be collected from the questionnaires conducted at long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up, will be used to evaluate the time course of outcomes after treatment with autologous bone marrow concentrate versus hyaluronic acid in patients who received either treatment as per the ''OA-bi-blind'' protocol.
- Conditions
- Knee Osteoarthritis
- Keywords
- hyaluronic acid injection, BMAC injection, Bone Marrow aspirate concentrate, long term follow-up, Prospective observational study, Hyalorunic acid, knee joint
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bilateral knee osteoarthritis treated with hyaluronic acid injection | Patients with bilateral osteoarthritis treated with hyaluronic acid injection treated within the research protocol "OA-bi-blind" | |
| Patients with bilateral knee osteoarthritis treated with BMAC injection | Patients with bilateral knee osteoarthritis treated with autologous bone marrow concentrate injection treated within the research protocol "OA-bi-blind" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, where a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.
Measured: baseline
Knee Injury and Osteoarthritis Outcome score- (KOOS Score)
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale
Measured: baseline
EuroQol Visual Analogue Scale (EQ-VAS )
This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Measured: baseline
Tegner Score
This questionnaire allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. In the study, the Tegner Score will be filled in directly by the investigator, through an interview the patient. In addition, questions will also be asked about return to sports and pre-injury, pre-treatment and recovered/achieved sports level .
Measured: baseline
EQ-5D (EuroQoL) Current Health Assessment
EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys
Measured: baseline
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Measured: baseline
Visual Analogue Scale (VAS)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).
Measured: baseline
Final treatment opinion
The patient should indicate satisfaction and relative degree with the treatment performed after a minimum of 4 years after infiltrative treatment. All patients will be able to indicate their health condition by choosing from this answers: much better", "somewhat better", "no change", "a little worse", "much worse".
Measured: baseline
Failure
The patient will be asked to indicate whether and when new infiltrative or surgical treatment was performed. Questions will also be asked about any complications and reinterventions
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start9 Feb 2024
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Zaffagnini, MD, Principal investigator, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164899
- Sponsor's protocol ID
- OA-bi Blind LT
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boffa A, Di Martino A, Andriolo L, De Filippis R, Poggi A, Kon E, Zaffagnini S, Filardo G. Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):3958-3967. doi: 10.1007/s00167-021-06793-4. Epub 2021 Nov 12.
PubMed 34767030Cavallo C, Boffa A, Andriolo L, Silva S, Grigolo B, Zaffagnini S, Filardo G. Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Int Orthop. 2021 Feb;45(2):525-538. doi: 10.1007/s00264-020-04703-w. Epub 2020 Jul 13.
PubMed 32661635Filardo G, Madry H, Jelic M, Roffi A, Cucchiarini M, Kon E. Mesenchymal stem cells for the treatment of cartilage lesions: from preclinical findings to clinical application in orthopaedics. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1717-29. doi: 10.1007/s00167-012-2329-3. Epub 2013 Jan 11.
PubMed 23306713Fortier LA, Strauss EJ, Shepard DO, Becktell L, Kennedy JG. Biological Effects of Bone Marrow Concentrate in Knee Pathologies. J Knee Surg. 2019 Jan;32(1):2-8. doi: 10.1055/s-0038-1676069. Epub 2018 Nov 30.
PubMed 30500973Trigkilidas D, Anand A. The effectiveness of hyaluronic acid intra-articular injections in managing osteoarthritic knee pain. Ann R Coll Surg Engl. 2013 Nov;95(8):545-51. doi: 10.1308/rcsann.2013.95.8.545.
PubMed 24165334
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid for the Treatment of Bilateral Knee Osteoarthritis. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06164899
- Acronym / sponsor ID
- OA-bi Blind LT
- Conditions
- Knee Osteoarthritis
- Keywords
- hyaluronic acid injection, BMAC injection, Bone Marrow aspirate concentrate, long term follow-up, Prospective observational study, Hyalorunic acid, knee joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 11 Dec 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.
This is a prospective observational study for long-term clinical evaluation (minimum 4-year follow-up) in patients treated within the research protocol "OA-bi-blind" (Double-blind randomized trial on the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid)
Detailed description
60 patients treated within the "OA-bi-blind" research protocol from 2016 to 2019 at the II Orthopaedic and Trauma Clinic of the Rizzoli Orthopaedic Institute will be recruited. These are patients undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol.Prior to enrollment, patients will be contacted provided they have released their personal or legal guardian's e-mail address and/or personal or legal guardian's telephone number in advance and only after verifying the patient's consent to be contacted again for research purposes. If the patient is interested in participating in the study, arrangements will be made with him or her to send the Informed Consent and Disclosure Letter.
The patient will have to return (by means of a pre-stamped envelope that he will have received together with the consent itself) the Informed Consent completed in all its parts to the address given in the information letter. Only upon obtaining the fully completed Informed Consent may the investigator subject the patient to a telephone interview.
Alternatively, the patient may receive the Informed Consent and the questionnaire for clinical evaluations digitally.Clinical score data will be collected from the questionnaires conducted at long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up, will be used to evaluate the time course of outcomes after treatment with autologous bone marrow concentrate versus hyaluronic acid in patients who received either treatment as per the ''OA-bi-blind'' protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bilateral knee osteoarthritis treated with hyaluronic acid injection | – | –Patients with bilateral osteoarthritis treated with hyaluronic acid injection treated within the research protocol "OA-bi-blind" |
| Patients with bilateral knee osteoarthritis treated with BMAC injection | – | –Patients with bilateral knee osteoarthritis treated with autologous bone marrow concentrate injection treated within the research protocol "OA-bi-blind" |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research Protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute
Key inclusion criteria (9 listed)
- -Patients undergoing injection for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute.
- Male or female patients, aged 18 to 75 years;
- Symptomatic bilateral knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- Failure after at least 2 months of conservative treatment;
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinic and radiological follow-up; And who meet the following criteria at the time of assessment by telephone or via telemedicine platform;
Key exclusion criteria (3 listed)
- Patients no longer on call;
- Patients who do not agree to undergo evaluation
- Patients who have passed away.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form
Time frame: baseline
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, where a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.
Knee Injury and Osteoarthritis Outcome score- (KOOS Score)
Time frame: baseline
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale
EuroQol Visual Analogue Scale (EQ-VAS )
Time frame: baseline
This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Tegner Score
Time frame: baseline
This questionnaire allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. In the study, the Tegner Score will be filled in directly by the investigator, through an interview the patient. In addition, questions will also be asked about return to sports and pre-injury, pre-treatment and recovered/achieved sports level .
EQ-5D (EuroQoL) Current Health Assessment
Time frame: baseline
EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys
Patient Acceptable Symptom State (PASS)
Time frame: baseline
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Visual Analogue Scale (VAS)
Time frame: baseline
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).
Final treatment opinion
Time frame: baseline
The patient should indicate satisfaction and relative degree with the treatment performed after a minimum of 4 years after infiltrative treatment. All patients will be able to indicate their health condition by choosing from this answers: much better", "somewhat better", "no change", "a little worse", "much worse".
Failure
Time frame: baseline
The patient will be asked to indicate whether and when new infiltrative or surgical treatment was performed. Questions will also be asked about any complications and reinterventions
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 18 Feb 2025.
- Background: PubMed 34767030Boffa A, Di Martino A, Andriolo L, De Filippis R, Poggi A, Kon E, Zaffagnini S, Filardo G. Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):3958-3967. doi: 10.1007/s00167-021-06793-4. Epub 2021 Nov 12.
- Background: PubMed 32661635Cavallo C, Boffa A, Andriolo L, Silva S, Grigolo B, Zaffagnini S, Filardo G. Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Int Orthop. 2021 Feb;45(2):525-538. doi: 10.1007/s00264-020-04703-w. Epub 2020 Jul 13.
- Background: PubMed 23306713Filardo G, Madry H, Jelic M, Roffi A, Cucchiarini M, Kon E. Mesenchymal stem cells for the treatment of cartilage lesions: from preclinical findings to clinical application in orthopaedics. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1717-29. doi: 10.1007/s00167-012-2329-3. Epub 2013 Jan 11.
- Background: PubMed 30500973Fortier LA, Strauss EJ, Shepard DO, Becktell L, Kennedy JG. Biological Effects of Bone Marrow Concentrate in Knee Pathologies. J Knee Surg. 2019 Jan;32(1):2-8. doi: 10.1055/s-0038-1676069. Epub 2018 Nov 30.
- Background: PubMed 24165334Trigkilidas D, Anand A. The effectiveness of hyaluronic acid intra-articular injections in managing osteoarthritic knee pain. Ann R Coll Surg Engl. 2013 Nov;95(8):545-51. doi: 10.1308/rcsann.2013.95.8.545.
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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.
Stefano Zaffagnini, MD principal investigator
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee 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 9 inclusion and 3 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 18 Feb 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 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?
Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form (time frame: baseline). The study lists 9 primary outcomes in all. 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 NCT06164899, which also lists 5 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 18 Feb 2025.