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

NCT03112122 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-08-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

autologous bone marrow concentrate

injection of autologous bone marrow concentrate

BIOLOGICAL

bone substitute i-FactorTM

subchondral injections of i-FactorTM

PROCEDURE

core decompression

subchondral anterograde drilling

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-11
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112122 on ClinicalTrials.gov