Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute

NCT03112122 | Terminated Phase 4

• 1 other identifier: BME-TARGET
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.

Conditions

Bone Marrow Edema

Keywords

Bone Marrow Edema; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• change of Visual Analogue Scale (VAS) score

  improvement in VAS score from baseline to follow up

  [Timepoint: Screening, 1 , 3 6, 12, 24 months]

Secondary Outcomes (3)

• International Knee Documentation Committee (IKDC) subjective score

  [Timepoint: Screening, 1 , 3 6, 12, 24 months]

• Knee Injury and Osteoarthritis Outcome (KOOS) Score

  [Timepoint: Screening, 1 , 3 6, 12, 24 months]

• Tegner Activity Level Scale

  [Timepoint: Screening, 1 , 3 6, 12, 24 months]

Study Arms (3)

core decompression technique

ACTIVE COMPARATOR

The standard surgical technique is the subchondral anterograde drilling, which permit a revascularization of the Bone Marrow Edema (BME) and a reduction of the intramedullary pressure (core decompression).

Procedure: core decompression

bone substitution (i-FactorTM)

EXPERIMENTAL

i-FactorTM is a combination of the mineral component of bone (Anorganic Bone Mineral) with a peptide replicating the cell-binding domain of Type-I collagen (P-15). It has been used in bone defects and in spine fusion providing good clinical results. Thus, i-FactorTM could be a valid and efficient bone substitute to treat BMLs with subchondral injections.

Biological: bone substitute i-FactorTM

injections of autologous Bone Marrow Concentrate (BMC)

EXPERIMENTAL

injections of autologous BMC.

Biological: autologous bone marrow concentrate

Interventions

autologous bone marrow concentrate BIOLOGICAL

injection of autologous bone marrow concentrate

injections of autologous Bone Marrow Concentrate (BMC)

bone substitute i-FactorTM BIOLOGICAL

subchondral injections of i-FactorTM

bone substitution (i-FactorTM)

core decompression PROCEDURE

subchondral anterograde drilling

core decompression technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18 and 75 years;
• Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
• Failure after at least two months of a conservative treatment;
• Single BME areas involving a single compartment of the knee;
• Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
• Signature of informed consent.

You may not qualify if:

• Patients incapable of discernment;
• History of allergy to calcium phosphates;
• Patients with malignancies;
• Patients with rheumatic diseases;
• Patients with diabetes;
• Patients suffering of metabolic disorders of the thyroid;
• Patients with history of abuse of alcohol, drugs or medication;
• Patients with advanced osteoarthritis (Kellgren-Lawrence grade\> 3);
• Body Mass Index\> 35;
• BME that involve more than one compartment;
• Patients with trauma in the 6 months prior to the intervention. -

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: randomized, controlled, three-arm, double-blind study

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 13, 2017
• Study Start: March 11, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)