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Completed

NCT Number: NCT03110666

Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study

This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

About this study

This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ranging from 40 to 75
  • Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);
  • Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
  • Signature of informed consent.

Exclusion criteria

  • Patients with trauma in the 6 months prior to the intervention;
  • Patients with malignancies;
  • Patients with rheumatic diseases;
  • Patients with diabetes;
  • Patients suffering from metabolic disorders of the thyroid;
  • Patients being abuse of alcohol, drugs or medications;
  • Body Mass Index> 35;

Treatment and study plan

Injection of autologous concentrated bone marrow aspirate

Biological

Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

Primary outcomes

  1. improvement of the International Knee Documentation Committee (IKDC) subjective score

    Time frame: Time Frame: 1,3,6, 12, 24 months evaluation

    (International Knee Documentation Committee)

Secondary outcomes

  1. improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)

    Time frame: Time Frame: 1,3,6, 12, 24 months evaluation

    (Knee Injury and osteoarthritis Outcome Score)

  2. evaluation of WORMS score for MRI

    Time frame: Time Frame: 6, 12, 24 months evaluation

    MRI score

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study

Acronym: IOC-target

Important dates

Study start
2016
Primary completion
2018
Study completion
2022
First posted
Apr 12, 2017
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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