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

Primary Purpose

Ankle Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

BMAC

About this trial

This is an interventional treatment trial for Ankle Osteoarthritis focused on measuring bone marrow aspirate concentrate, hyaluronic acid, BMAC, HA, ankle, ankle injection, ankle OA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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;

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

Sites / Locations

Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BMAC injection

HA injections

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04883892

First Posted

May 7, 2021

Last Updated

September 27, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04883892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2021 (Actual)

Primary Completion Date

June 15, 2022 (Actual)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BMAC injection

Arm Type

Experimental

Arm Description

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

Arm Title

HA injections

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

BMAC

Other Intervention Name(s)

Bone Marrow Aspirate Concentrate injection

Intervention Description

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

Intervention Name(s)

Other Intervention Name(s)

Hyaluronic Acid injections

Intervention Description

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.

Primary Outcome Measure Information:

Title

AOS (Ankle Osteoarthritis Scale)

Description

Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment

Time Frame

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

Secondary Outcome Measure Information:

Title

AOFAS (The American Orthopedic Foot and Ankle Score)

Description

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.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

VAS function (Visual Analog Score - function)

Description

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.

Time Frame

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

Title

VAS pain (Visual Analog Score - pain)

Description

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.

Time Frame

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

Title

EuroQol Visual Analogue Scale (EQ-VAS)

Description

0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"

Time Frame

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

Title

EQ-5D (EuroQoL) Current Health Assessment

Description

Score for the assessment of the quality of life of the patient.

Time Frame

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

Title

Patient Acceptable Symptom State (PASS)

Description

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).

Time Frame

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

Title

Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams

Description

RX and MRI will be performed at 12 and 24 month after treatment

Time Frame

12, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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; 9. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index > 35;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesca Vannini, MD

Phone

051-6366878

francesca.vannini@ior.it

First Name & Middle Initial & Last Name or Official Title & Degree

Daniele Andreani, M.Sc.

daniele.andreani@ior.it

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

ZIP/Postal Code

40124

Country

Italy

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27566242

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.

Results Reference

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PubMed Identifier

26069591

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.

Results Reference

background

PubMed Identifier

20934692

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.

Results Reference

background

PubMed Identifier

25662594

Citation

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.

Results Reference

background

PubMed Identifier

27994723

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.

Results Reference

background

PubMed Identifier

19067120

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.

Results Reference

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

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