OBJECTIVE: To compare the clinical outcomes of the core decompression combined with autologous bone marrow mesenchymal stem cells (BMSCs) transplantation with the isolated core decompression for the treatment of early avascular necrosis of the femoral head (ANFH). METHODS:From May 2006 to October 2008, 8 patients (16 hips) with early ANFH were treated. There were 7 males and 1 female with an average age of 35.7 years (range, 19-43 years). According to the system of the Association Research Circulation Osseous (ARCO): 4 hips were classified as stage II a, 2 as stage II b, 1 as stage II c, and 1 as stage III a in group A; 2 hips were classified as stage II a, 2 as stage II b, 3 as stage II c, and 1 as stage III a in group B. The average disease course was 1.1 years (range, 4 months to 2 years). The patients were randomly divided into 2 groups according to left or right side: group A, only the core decompression was used; group B, both the core decompression and autologous BMSCs transplantation were used. The Harris score and visual analogue scale (VAS) score were determined, imaging evaluation was carried out by X-rays and MRI pre- and post-operatively. The erythrocyte sedimentation rate, C-reactive protein, liver function, renal function, and immunoglobulin were detected for safety evaluation. RESULTS: All incisions healed by first intention. Eight patients were followed up 12-42 months (23.5 months on average). The clinical symptoms of pain and claudication were gradually improved. The Harris scores and VAS scores of all patients were increased significantly at 3, 6, and 12 months after operation (P < 0.05). There was no significant difference between groups A and B 3 and 6 months after operation (P > 0.05), but there was significant difference between groups A and B 12 months after operation (P < 0.05). The necrosis area of femoral head in groups A and B were 18.13% +/- 2.59% and 13.25% +/- 2.12%, respectively, showing significant difference (P < 0.05). In group A, femoral head collapsed 12 months after operation in 1 case of stage III. No complication of fever, local infection CONCLUSION: The core decompression and the core decompression combined with BMSCs transplantation are both occurred. effective for the treatment of early ANFH. The core decompression combined with BMSCs transplantation is better than core decompression in the relief of pain and postponing head collapse.
RCT Entities:
OBJECTIVE: To compare the clinical outcomes of the core decompression combined with autologous bone marrow mesenchymal stem cells (BMSCs) transplantation with the isolated core decompression for the treatment of early avascular necrosis of the femoral head (ANFH). METHODS: From May 2006 to October 2008, 8 patients (16 hips) with early ANFH were treated. There were 7 males and 1 female with an average age of 35.7 years (range, 19-43 years). According to the system of the Association Research Circulation Osseous (ARCO): 4 hips were classified as stage II a, 2 as stage II b, 1 as stage II c, and 1 as stage III a in group A; 2 hips were classified as stage II a, 2 as stage II b, 3 as stage II c, and 1 as stage III a in group B. The average disease course was 1.1 years (range, 4 months to 2 years). The patients were randomly divided into 2 groups according to left or right side: group A, only the core decompression was used; group B, both the core decompression and autologous BMSCs transplantation were used. The Harris score and visual analogue scale (VAS) score were determined, imaging evaluation was carried out by X-rays and MRI pre- and post-operatively. The erythrocyte sedimentation rate, C-reactive protein, liver function, renal function, and immunoglobulin were detected for safety evaluation. RESULTS: All incisions healed by first intention. Eight patients were followed up 12-42 months (23.5 months on average). The clinical symptoms of pain and claudication were gradually improved. The Harris scores and VAS scores of all patients were increased significantly at 3, 6, and 12 months after operation (P < 0.05). There was no significant difference between groups A and B 3 and 6 months after operation (P > 0.05), but there was significant difference between groups A and B 12 months after operation (P < 0.05). The necrosis area of femoral head in groups A and B were 18.13% +/- 2.59% and 13.25% +/- 2.12%, respectively, showing significant difference (P < 0.05). In group A, femoral head collapsed 12 months after operation in 1 case of stage III. No complication of fever, local infection CONCLUSION: The core decompression and the core decompression combined with BMSCs transplantation are both occurred. effective for the treatment of early ANFH. The core decompression combined with BMSCs transplantation is better than core decompression in the relief of pain and postponing head collapse.