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OpenTrials
Completed

NCT Number: NCT03110679

Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid

OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

About this study

a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female patients, aged between 18 and 75 years;
  • Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
  • Failure after two months of conservative treatment;
  • Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
  • Signature of informed consent.

Exclusion criteria

  • Patients incapable of discernment;
  • Patients with malignancy
  • Patients with rheumatic diseases;
  • Patients with diabetes;
  • Patients with metabolic disorders of the thyroid;
  • Patients belonging abuse of alcohol, drugs or medications;
  • Patients with misalignment of the lower limbs than 10 °;
  • Body Mass Index> 40;
  • Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.

Treatment and study plan

injection of autologous bone marrow concentrate

Biological

injection of hyaluronic acid.

Biological

Primary outcomes

  1. International Knee Documentation Committee (IKDC)-Subjective score

    Time frame: Time Frame: 6 months

    Clinical improvement, measured by the change in scores IKDC Subjective

Secondary outcomes

  1. International Knee Documentation Committee (IKDC)-Subjective score

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

    Stability of the initial clinical improvement between 6 and 24 months

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS).

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

    Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: OA-bi-Blind

Important dates

Study start
2016
Primary completion
2016
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
Aug 4, 2021

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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