Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis

NCT04883892 | Terminated DMC

• 1 other identifier: BMAC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. After 12 months patients in the control group can decide to cross-over in the treatment group.

Conditions

Ankle Osteoarthritis

Keywords

bone marrow aspirate concentrate; hyaluronic acid; BMAC; HA; ankle; ankle injection; ankle OA

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 1, 3, 6, 12, 24 months

Secondary Outcomes (1)

• AOFAS (The American Orthopedic Foot and Ankle Score)

  Baseline, 1, 3, 6, 12, 24 months

Other Outcomes (6)

• VAS function (Visual Analog Score - function)

  Baseline, 1, 3, 6, 12, 24 months

• VAS pain (Visual Analog Score - pain)

  Baseline, 1, 3, 6, 12, 24 months

• EuroQol Visual Analogue Scale (EQ-VAS)

  Baseline, 1, 3, 6, 12, 24 months

Study Arms (2)

BMAC injection

EXPERIMENTAL

Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint

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.

Procedure: HA

Interventions

BMAC PROCEDURE

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

Also known as: Bone Marrow Aspirate Concentrate injection

BMAC injection

HA PROCEDURE

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.

Also known as: Hyaluronic Acid injections

HA injections

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• \. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

Location

Related Publications (6)

• 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.

  PMID: 27566242 BACKGROUND

• Kennedy 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.

  PMID: 26069591 BACKGROUND

• Giannini 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.

  PMID: 20934692 BACKGROUND

• Buda 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.

  PMID: 25662594 BACKGROUND

• Vannini 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.

  PMID: 27994723 BACKGROUND

• Luciani 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.

  PMID: 19067120 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT, single-blind, allocation 1:1. After 12 months patients in the control group are allowed to cross-over in the treatment group

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: December 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: August 11, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)