NCT03112122

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

Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bone Marrow Edema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-11
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-04-13
• Last updated: 2018-08-09

Locations

1 site across 1 country: Italy