Treatment of the Femoral Head With Core Decompression and Cell Grafting Increases the Survivorship of the Hip

Overview

About this study

The purpose of this study is to determine if treatment of the femoral head with core decompression and cell grafting increases the survivorship of the hip when compared to core decompression alone. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients who have ARCO Stage I and Stage II (i.e., no evidence of collapse on MRI or x-ray) atraumatic osteonecrosis of the femoral head (ONFH), all lesion sizes, major risk factors (e.g., corticosteroids, alcohol, organ recipient). Idiopathic patients for which no risk factor has yet been identified will be included. The patients will include all sexes, ethnicities, and races. The age range to be recruited is 18 to 90 years.
  • The orthopaedic surgeon has decided that core decompression (with or without BMAC) is the appropriate treatment.
  • The procedure has been discussed and agreed to by the patient.

Exclusion Criteria: 

  • ONFH patients associated with sickle cell disease, major trauma, post-irradiation ONFH, Gaucher Disease, and Perthes Disease will be excluded as the natural history of the disease in these patients may potentially differ from that of secondary ONFH (e.g., corticosteroid, alcohol).
  • Patients who are pregnant or breastfeeding will be excluded from this study, as it is not advisable for radiographs to be taken.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/16/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rafael Sierra, M.D.

Contact us for the latest status

Contact information:

Erin Hennessey

(507) 284-1975

Hennessey.Erin@mayo.edu

More information

Publications

Publications are currently not available