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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2025-08-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ankle Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BMAC injection

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

Group Type EXPERIMENTAL

BMAC

Intervention Type 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

HA injections

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.

Group Type ACTIVE_COMPARATOR

HA

Intervention Type 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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Bone Marrow Aspirate Concentrate injection Hyaluronic Acid injections

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No