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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Core decompression |
|
| Bone marrow | Experimental | core decompression plus autologous concentrated bone marrow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| core decompression with autologous bone marrow implantation | Procedure | core biopsy with injection of 40 ml concentrated autologous bone marrow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of total prosthesis | Need to undergo a surgical treatment total prosthesis | 24, 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | Visual analogue scale | 24, 60 months |
| functional status | Lequesne and WOMAC scores | 24, 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Liège | Liège | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28988340 | Derived | Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018 Jul;42(7):1429-1435. doi: 10.1007/s00264-017-3650-8. Epub 2017 Oct 7. |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| core decompression of the femoral head | Procedure | core biopsy with injection of 40 ml saline solution in place of bone marrow. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |