Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid

NCT06164899 | Completed

• 1 other identifier: OA-bi Blind LT
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Knee Osteoarthritis

Keywords

hyaluronic acid injection; BMAC injection; Bone Marrow aspirate concentrate; long term follow-up; Prospective observational study; Hyalorunic acid; knee joint

Outcome Measures

Primary Outcomes (9)

• 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.

  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

  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).

  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 .

  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

  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.

  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).

  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".

  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

  baseline

Study Arms (2)

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"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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;
• Capable patients
• Signature of informed consent
• Availability

You may not qualify if:

• Patients no longer on call;
• Patients who do not agree to undergo evaluation
• Patients who have passed away.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

• 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.

  PMID: 34767030 BACKGROUND

• Cavallo 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.

  PMID: 32661635 BACKGROUND

• Filardo 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.

  PMID: 23306713 BACKGROUND

• Fortier 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.

  PMID: 30500973 BACKGROUND

• Trigkilidas 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.

  PMID: 24165334 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stefano Zaffagnini, MD

  Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: February 9, 2024
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

IT (1)