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

September 27, 2023 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40124
        • Recruiting
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMAC injection
Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint
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

Other Names:
  • Bone Marrow Aspirate Concentrate injection
Active Comparator: 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.
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.
Other Names:
  • Hyaluronic Acid injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOS (Ankle Osteoarthritis Scale)
Time Frame: 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
Baseline, 1, 3, 6, 12, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS (The American Orthopedic Foot and Ankle Score)
Time Frame: 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.
Baseline, 1, 3, 6, 12, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS function (Visual Analog Score - function)
Time Frame: Baseline, 1, 3, 6, 12, 24 months
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
VAS pain (Visual Analog Score - pain)
Time Frame: Baseline, 1, 3, 6, 12, 24 months
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
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: Baseline, 1, 3, 6, 12, 24 months
0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"
Baseline, 1, 3, 6, 12, 24 months
EQ-5D (EuroQoL) Current Health Assessment
Time Frame: Baseline, 1, 3, 6, 12, 24 months
Score for the assessment of the quality of life of the patient.
Baseline, 1, 3, 6, 12, 24 months
Patient Acceptable Symptom State (PASS)
Time Frame: Baseline, 1, 3, 6, 12, 24 months
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
Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams
Time Frame: 12, 24 months
RX and MRI will be performed at 12 and 24 month after treatment
12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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