Recombinant Human Bone Morphogenetic Protein-2 in Debridement and Impacted Bone Graft for the Treatment of Femoral Head Osteonecrosis

Sun, Wei; Li, Zirong; Gao, Fuqiang; Shi, Zhencai; Zhang, Qidong; Guo, Wanshou

doi:10.1371/journal.pone.0100424

Cited by 59 publications

(61 citation statements)

References 27 publications

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“…Therapies using cells [4][5][6], proteins, and other bone growth-promoting substances [2,7,8] have been proposed, and various cell therapies using autologous marrow cells are already being attempted. Non-cellular therapeutic strategies using growth factors have been proposed; however, there has been little progress with regard to the verification of animal experiments, primarily because of the absence of an animal model for femoral head-specific necrosis [9,16] and secondarily because of the lack of a technique to locally deliver the growth factor [17].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, non-cellular therapeutic strategies that use growth factors have also been proposed [2,3,7,8]. In an animal study using adult rabbits, we reported that a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor (rhFGF)-2 not only promoted the regeneration of the necrotic bone but also suppressed the progression of ONFH [9].…”

Section: Introductionmentioning

confidence: 99%

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A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head

Kuroda

Asada

et al. 2015

International Orthopaedics (SICOT)

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Purpose We evaluated the safety and clinical outcomes of a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor (rhFGF)-2 for the treatment of the precollapse stage of osteonecrosis of the femoral head (ONFH). Methods Patients with ONFH (precollapse stage ≤2) received a single local administration of 800 μg of rhFGF-2-impregnated gelatin hydrogel and were followed up for one year. The surgery was performed using a minimally invasive technique involving a 1-cm skin incision, and walking was allowed from day one postoperatively. The primary outcomes included occurrence of adverse events and complications. The secondary outcomes included changes in the Harris hip scores, visual analog scale for pain scores, University of California, Los Angeles (UCLA) activity scores, and radiological images. Results We included ten patients, of which five experienced 14 adverse events, including one complication from spinal anesthesia. However, patients completely recovered from all adverse events. The mean clinical scores significantly improved by one year postoperatively compared with the pre-operative scores (before vs. after: visual analog score for pain, 21.2 vs. 5.3 mm; UCLA activity score, 5.5 vs. 6.6; Harris hip score, 81.0 vs. 96.9 points). There was only one case of femoral head collapse; however, this occurred in a hip with extensive necrosis. Stage progression and collapse did not occur in the other nine cases. Computed tomography confirmed bone regeneration in the femoral heads. Conclusions Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse ONFH was feasible and safe.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head

Kuroda

Asada

et al. 2015

International Orthopaedics (SICOT)

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“…After a 2-year follow-up, there was a marked increase in mean HHS from 34 points (range, 22 to 50 points) pre-operatively to 87 points (range, 70 to 90 points) post-operatively (p>0.05). Similarly, a randomized trial by Sun et al [26] evaluated the use of rhBMP-2 with impact NVBG (n=43) compared to NVBG alone (n=36) for the treatment of pre-collapse ONFH. After a mean follow-up of 6 years (range, 5 to 8 years), the authors found a marked difference in survival rates between the control and experimental cohorts (72 versus 82 %, respectively).…”

Section: Use Of Bmpsmentioning

confidence: 99%

A current review of non-vascularized bone grafting in osteonecrosis of the femoral head

Pierce

Elmallah

Jauregui

et al. 2015

Curr Rev Musculoskelet Med

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Over the past three decades, non-vascularized bone grafts have been demonstrated to be viable treatments for preand early post-collapse osteonecrosis of the femoral head; however, there are limited reviews on this topic. Therefore, the purposes of this review are to (1) provide a summary of the different surgical techniques and their respective clinical outcomes and (2) evaluate new adjunct therapies. Originally, nonvascularized bone grafting was performed using the Phemister technique with varying results. More recently, newer techniques such as the lightbulb and trapdoor are used to place non-vascularized bone grafts with excellent results. The addition of various biological agents has demonstrated positive results; however, further studies are needed to confirm the best appropriate indications and to elucidate long-term results.

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“…Finally, little evidence has been reported on osteonecrosis, with four published studies, one of which was comparative [17] and described similar results with or without rhBMPs. No complications or adverse events have been reported in these studies.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, there are two commercially available BMPs, recombinant human rh BMP-2 and rhBMP-7. They have been tested in several preclinical studies showing the ability to induce bone regeneration [9][10][11], and evaluated in clinical trials to treat various bone disorders such as non-unions, open fractures, and osteonecrosis [12][13][14][15][16][17]. The successful application of BMPs led, in July 2002, to the approval by the European Medicines Agency (EMA) of rhBMP-2 (InductOs®) for the treatment of single-level lumbar spine fusion and for acute tibial fractures in adults [18].…”

Section: Introductionmentioning

confidence: 99%

Clinical application of bone morphogenetic proteins for bone healing: a systematic review

Krishnakumar

Roffi

Reale

et al. 2017

International Orthopaedics (SICOT)

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Purpose This paper documents the existing evidence on bone morphogenetic proteins (BMPs) use for the treatment of bone fractures, non-union, and osteonecrosis, through a review of the clinical literature, underlying potential and limitations in terms of cost effectiveness and risk of complications. Methods A systematic review was performed on the PubMed database using the following string: (bone morphogenetic proteins OR BMPs) and (bone repair OR bone regeneration) including papers from 2000 to 2016. The search focused on clinical trials dealing with BMPs application to favor bone regeneration in bone fractures, non-union, and osteonecrosis, in English language, with level of evidence I, II, III, and IV. Relevant data (type of study, number of patients, BMPs delivery material, dose, site, follow-up, outcome, and adverse events) were extracted and analyzed. Results Forty-four articles met the inclusion criteria: 10 randomized controlled trials (RCTs), 7 comparative studies, 18 case series, and 9 case reports. rhBMP-2 was documented mainly for the treatment of fractures, and rhBMP-7 mainly for non-unions and osteonecrosis. Mixed results were found among RCTs and comparative papers: 11 reported positive results for BMPs augmentation, 3 obtained no significant effects, and 2 showed negative results. The only study comparing the two BMPs showed a better outcome with rhBMP-2 for non-union treatment. Conclusion Clinical evidence on BMPs use for the treatment of fractures, non-union, and osteonecrosis is still controversial, with the few available reports being mainly of low quality. While positive findings have been described in many studies, mixed results are still present in the literature in terms of efficacy and adverse events. The difficulties in drawing clear conclusions are also due to the studies heterogeneity, mainly in terms of different BMPs applied, with different concomitant treatments for each bone pathology. Therefore, further research with well-designed studies is needed in order to understand the real potential of this biological approach to favour bone healing.

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Recombinant Human Bone Morphogenetic Protein-2 in Debridement and Impacted Bone Graft for the Treatment of Femoral Head Osteonecrosis

Cited by 59 publications

References 27 publications

A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head

A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head

A current review of non-vascularized bone grafting in osteonecrosis of the femoral head

Clinical application of bone morphogenetic proteins for bone healing: a systematic review

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