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

Not Applicable

Recruiting

• Conditions: Ankle Osteoarthritis
• Interventions: Procedure: BMAC; Procedure: HA

• Registration Number: NCT04883892
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

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 Timeline

• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Study Start: 2021-12-15
• Primary Completion: 2022-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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;

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BMAC injection	BMAC	Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint
HA injections	HA	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.

Primary Outcome Measures

Name	Time	Method
AOS (Ankle Osteoarthritis Scale)	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

Secondary Outcome Measures

Name	Time	Method
AOFAS (The American Orthopedic Foot and Ankle Score)	Baseline, 1, 3, 6, 12, 24 months	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy