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Completed

NCT Number: NCT01544712

Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.

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Key information

Conditions

Non Traumatic Osteonecrosis of the Femoral Head (Hip) Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who have a non traumatic ON of the femoral head
  • Stage 3 ON (subchondral fracture).
  • Age > 18 years
  • Be able and willing to participate in the study

Exclusion criteria

  • evidence of malignant disorder in the past five years
  • Patient unable to undergo a MRI.
  • Patient who is positive for an HIV, hepatitis B or C infection.

Treatment and study plan

core decompression with autologous bone marrow implantation

Procedure

core biopsy with injection of 40 ml concentrated autologous bone marrow.

core decompression of the femoral head

Procedure

core biopsy with injection of 40 ml saline solution in place of bone marrow.

Primary outcomes

  1. reduction of total prosthesis

    Time frame: 24, 60 months

    Need to undergo a surgical treatment total prosthesis

Secondary outcomes

  1. Pain reduction

    Time frame: 24, 60 months

    Visual analogue scale

  2. functional status

    Time frame: 24, 60 months

    Lequesne and WOMAC scores

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 6, 2012
Registry last updated
Mar 6, 2012

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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