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

Phase 4

Terminated

• Conditions: Bone Marrow Edema
• Interventions: Procedure: core decompression; Biological: bone substitute i-FactorTM; Biological: autologous bone marrow concentrate

• Registration Number: NCT03112122
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.

Study Timeline

• Study Start: 2016-03-11
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
core decompression technique	core decompression	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).
bone substitution (i-FactorTM)	bone substitute i-FactorTM	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.
injections of autologous Bone Marrow Concentrate (BMC)	autologous bone marrow concentrate	injections of autologous BMC.

Primary Outcome Measures

Name	Time	Method
change of Visual Analogue Scale (VAS) score	[Timepoint: Screening, 1 , 3 6, 12, 24 months]	improvement in VAS score from baseline to follow up

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome (KOOS) Score	[Timepoint: Screening, 1 , 3 6, 12, 24 months]	improvement in KOOS score from baseline to follow up
Tegner Activity Level Scale	[Timepoint: Screening, 1 , 3 6, 12, 24 months]	improvement in activity level scale from baseline to follow up
International Knee Documentation Committee (IKDC) subjective score	[Timepoint: Screening, 1 , 3 6, 12, 24 months]	improvement in IKDC subjective score from baseline to follow up

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy