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

Ankle Osteoarthritis Clinical Trial

Official title:

BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883892
• Other study ID #: BMAC
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: July 2027

Study information

• Verified date: September 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Francesca Vannini, MD
• Phone: 051-6366878
• Email: francesca.vannini[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2027
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with degenerative ankle cartilage disease;

2. Unilateral involvement on the ankle;

3. Signs and symptoms of degenerative pathology of the ankle cartilage;

4. Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);

5. No clinically significant electrocardiographic changes (recently performed ECG).

6. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion Criteria:

1. Patients unable to give consent;

2. Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;

3. Patients who have undergone ankle surgery in the preceding 12 months;

4. Patients with malignant neoplasms;

5. Patients with rheumatic diseases;

6. 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;

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

Procedure:
• BMAC
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
• HA
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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS function (Visual Analog Score - function)	the scale is to expect the patient to select the number that best describes their functional disability status, in a range of length from 0 to 10 cm. The higher the value indicated the higher the degree of disability.	Baseline, 1, 3, 6, 12, 24 months
Other	VAS pain (Visual Analog Score - pain)	the scale is to expect the patient to select the number that best describes their pain status, in a range of length from 0 to 10 cm. The higher the value indicated the higher the degree of disability.	Baseline, 1, 3, 6, 12, 24 months
Other	EuroQol Visual Analogue Scale (EQ-VAS)	0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"	Baseline, 1, 3, 6, 12, 24 months
Other	EQ-5D (EuroQoL) Current Health Assessment	Score for the assessment of the quality of life of the patient.	Baseline, 1, 3, 6, 12, 24 months
Other	Patient Acceptable Symptom State (PASS)	tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no).	Baseline, 1, 3, 6, 12, 24 months
Other	Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams	RX and MRI will be performed at 12 and 24 month after treatment	12, 24 months
Primary	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	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.	Baseline, 1, 3, 6, 12, 24 months