Background
Methods
Search terms | |
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#4 Search ((#1) AND #2) AND #3 #3 Search “patient” OR “clinic” #2 Search (“bone repair” OR “bone regeneration” OR “repairing bone defect” OR “repair of bone” OR “osteanagenesis” OR “osteanaphysis” OR “osteoanagenesis”) #1 Search “Scaffold*” |
Results
Scaffold | Case | Duration | Trial | Results | Complications | Reference |
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Collagen scaffold | Long bone non-unions (group rhBMP-7 n = 60 group PRP) n = 60) | > 9 months | The purpose of this prospective randomized clinical study was to compare the efficacy of rhBMP-7 and PRP as bone-stimulating agents in the treatment of persistent fracture non-unions. | Both clinical and radiological union occurred in 52 (86.7%) cases of the rhBMP-7 group compared to 41 (68.3%) cases of the PRP group, with a lower median clinical and radiographic healing time observed in the rhBMP-7 group. | Complications including severe, moderate and mild; adverse events were classified as serious or non-serious | Calori et al. [31] |
Porous collagen I scaffold | Volumetric bone deficiencies (n = 10) | 3 years | The clinical outcomes of ten patients with volumetric bone deficiencies treated with MSCs and bone marrow aspirate are presented in this case series. Results were evaluated with radiographs. | All patients showed bony healing and/or sufficient new bone formation within follow-up. There were no restrictions to any physical activities prior to the causative disease at latest follow-up. All patients returned to their profession after treatment. | 1 prolonged hematoma | Jager et al. [18] |
Absorbable collagen sponge scaffold | Open tibial fractures (n = 450) | 12 months | The objective of this study was to evaluate the safety and efficacy of the use of rhBMP-2. 450 patients with an open tibial fracture were randomized to receive either the standard of care, the standard of care and an implant containing 0.75 mg/mL of rhBMP-2, or the standard of care and an implant containing 1.50 mg/mL of rhBMP-2. The rhBMP-2 implant (rhBMP-2 applied to an absorbable collagen sponge) was placed over the fracture at the time of definitive wound closure. | The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia. | Local adverse events including inflammation, infection, hardware failure, pain, and complications. | Govender et al. [19] |
Absorbable collagen sponge scaffold | Open tibial fractures (n = 510) | 12 months | The objective of the current study was to perform a subgroup analysis of the combined data from these studies. 510 patients were randomized to receive the control treatment or the control treatment and an absorbable collagen sponge impregnated with one of two concentrations of rhBMP-2. The rhBMP-2 implant was placed over the fracture at the time of definitive wound closure. | The addition of rhBMP-2 to the treatment of type-III open tibial fractures can significantly reduce the frequency of bone-grafting procedures and other secondary interventions. This analysis establishes the clinical efficacy of rhBMP-2 combined with an absorbable collagen sponge implant for the treatment of these severe fractures | NC | Swiontkowski et al. [20] |
Collagen sponge and Hap scaffold | Volumetric bone deficiencies patients (n = 39) with collagen scaffold (n = 12) and HA scaffold(n = 27) | > 6 months | The study investigated the potency of BMAC to augment bone grafting and support bone healing. The functional and radiographic outcome of 39 patients with treated with BMAC are presented and evaluated | All patients showed new bone formation in radiographs during follow-up. Two patients underwent revision surgery due to a lack in bone healing. The postoperative bone formation and complete bone healing appeared earlier in the HA group in contrast to the Collagen group. | 1 persisting hematoma, 3 wound secretions | Jager et al. [32] |
Gel foam scaffold | 16 patients (n = 51 ribs) who underwent costectomy with gel foam scaffold and 15 patients (n = 33 ribs) with no scaffold. | 6 months | The aim of the study is to compare rib regeneration with a scaffold placed intra-periosteally against no scaffold, after costectomy in adolescent idiopathic scoliosis. Patients were analyzed radiographically for rib regeneration and morphology. | The resulting data showed that majority of ribs re-grew to normal morphology in 3–6 months in the trial group. Ribs treated by placement of gel foam scaffold regenerate to a near normal radiological profile within 6 months of costectomy compared to a slower regeneration in those without gel foam scaffold. | NC | Philip et al. [35] |
Complex cellular scaffold | Post-traumatic nature bone defects (n = 8) | 6–8 weeks | Critical size defects were treated with the IM technique. Morphological characteristics, cell composition, and growth factor expression were compared with healthy diaphyseal P. Functional and molecular evaluation of MSC activity was performed. | Both tissues shared similar morphology although IM was significantly thicker than P. The IM resembles periosteum with a cellular composition and molecular profile facilitating large defect repair and therefore may be described as an “induced-periosteum” | NC | Cuthbert et al. [33] |
Intra-operative cellular bone substitution material scaffold | Various bone healing disturbances (n = 101) | 2-24 months | The objective of the study was to evaluate new bone formation after the application of BMAC as well as to record complications. The application of BMAC was performed via a local injection as part of a core decompression (n = 72) or by the local adsorption of intra-operative cellular bone substitution material (scaffold) incubated with BMAC during osteosynthesis (n = 17)or in further surgery (n = 12). | Only 2 patients were observed complications. Infections, excessive new bone formation, induction of tumor formation and morbidity due to the bone marrow aspiration from the iliac crest were not seen. | 2 complications | Hendrich et al. [34] |
Scaffold | Case (n = sample) | Duration | Trial | Results | Complications | Reference |
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HAp | Bone tumors (n = 3) | 29–43 months | MSCs obtained from each patient’s bone marrow cells were forced to differentiate into osteoblasts followed by bone matrix formation on HAp ceramics to heal bone tumors using tissue-engineered implants. Serial plain radiographs and computed tomography images were used to observe results. | The strong osteogenic ability of the implants, as evidenced by high osteoblastic activity, was confirmed. The tissue-engineered HAp was used to fill the patient’s bone cavity after tumor curettage. Immediate healing potential was found and no adverse reactions were noted in these patients | NC | Morishita et al. [36] |
Porous HAp ceramic scaffold | Large bone diaphysis defects (n = 4) | 6.5 years | Cells from the patients’ bone marrow stroma were expanded in culture and seeded onto porous HAp ceramic scaffolds designed to match the bone deficit in terms of size and shape. Conventional radiographs and CT scans evaluated patients. | No major complications occurred in the early or late postoperative periods. No signs of pain, swelling, or infection were observed at the implantation site. Complete fusion between the implant and the host bone occurred 5 to 7 months after surgery. | No major complications and No signs of pain, swelling, or infection. | Marcacci et al. [37] |
HAp | Large bone defects (n = 3) | > 15 months | Osteoprogenitor cells were isolated from bone marrow and expanded ex vivo. These cells were placed on macroporous hydroxyapatite scaffolds and implanted at the lesion sites. External fixation was provided initially for mechanical stability and was subsequently removed. | In all three patients, radiographs and computed tomographic scans revealed abundant callus formation along the implants and good integration at the interfaces with the host bones by the second month after surgery. | NC | Quarto et al. [38] |
IP-CHA | 22 patients (n = 30 hips) who used BMMNCs with IP-CHA and 8 patients (n = 9 hips) with cell-free IP-CHA of osteonecrosis of the femoral head | > 12 months | We have investigated the effectiveness of the transplantation of BMMNCs and cell-free with IP-CHA on early bone repair for osteonecrosis of the femoral head. | In the BMMNC group, a reduction in the size of the osteonecrotic lesion was observed subsequent to hypertrophy of the bone in the transition zone and three patients were detected extensive collapse. In the control group, severe collapse of the femoral head occurred in six of eight hips. | No intra- or post-operative complications | Yamasaki et al. [39] |
HAp/type I collagen composite scaffold | Bone defects by benign bone tumors with HAp/Col (n = 63) and β-TCP (n = 63) | 18 and 24 weeks | The efficacy and safety of HAp/Col were assessed in comparison β-TCP. X-ray images and blood tests and observation of the surgical site were performed to evaluate the efficacy and safety of the implants. | The highest grade of bone regeneration was more frequent in the porous HAp/Col group than in the porous β-TCP group (p = 0.0004 and 0.0254 respectively). The incidence of adverse effects was higher in the porous HAp/Col group than in the β-TCP group. | NC | Sotome et al. [40] |
HAp/TCP scaffold | Spondylolisthesis (n = 25) | 12–27 months | Autograft/ TSRH pedicle screw instrumentation (n = 5), rhBMP-2/TSRH (n = 11), and rhBMP-2 only without internal fixation (n = 9). On each side, 20 mg of rhBMP-2 was delivered on a carrier consisting of 60% HAp and 40% TCP granules (10 cm3/side). | RhBMP-2 with the biphasic CaPs granules induced radiographic posterolateral lumbar spine fusion with or without internal fixation in patients whose spondylolisthesis did not exceed grade 1. Statistically greater and quicker improvement in patient-derived clinical outcome was measured in the rhBMP-2 groups. | No complications | Boden et al. [41] |
rCPBS scaffold | Recalcitrant tibial fracture nonunion (n = 20) | 14 ± 2.7 months | All patients were treated with a procedure including debridement and decortications of the bone ends, nonunion fixation with a locking plate, and filling of the bony defect with a combined graft of rhBMP-7 (as osteoinductor) with an rCPBS (as scaffold) | No specific complication of rCPBS or rhBMP-7 was encountered. The application of rCPBS combined with rhBMP-7, without any bone grafting, is safe and efficient in the treatment of recalcitrant bone union. | No specific complication | Ollivier et al. [43] |
β-TCP scaffold | Femoral defects with autologous MSC/ β-TCP (n = 9) and β-TCP (n = 9) | 12 months | Compare healing quality of implantation into femoral defects during revision total hip arthroplasty, containing either expanded autologous MSC (trial group) or Β-phosphate alone (control group). | A significant difference in the bone defect healing was observed between both groups of patients (p < 0.05). Trabecular remodeling was found in all nine patients in the trial group, and only 1 patient in the control group. | 2 dislocation and 1 pulmonary embolism, and 1 cardiac arrhythmia | Sponer et al. [42] |
Bonelike scaffold | Medial compartment osteoarthritis of the knee (n = 11) | 12 months | The aim of the present work was to assess the biological behavior of Bonelike graft and osteoconductive properties and resorption characteristics of the granulesin. Radiological follow-up, scanning electron microscopy, histological analysis and histomorphometric measurements were conducted on the retrieved samples to assess bone regeneration in the defect area. | Bonelike acted as an excellent bioactive scaffold, allowing the migration, proliferation, and differentiation of bone cells on its surface, and therefore regeneration of the defects was achieved in a rapid, controlled manner. | NC | Gutierres et al. [47] |
BoneSave (TCP/HAp) | Posterolateral inter-transverse spinal defects(n = 45) | 46 months | Analogue scales for pain, patient global impression of change, work status, persisting symptoms and patient satisfaction data, radiological evaluation of fusion was carried out from the most recent spinal radiographs available for each patient | Significant post-operative improvements were seen across all outcome measures in the large majority of cases. Successful fusion was achieved in 56.7% of cases. | Avoid donor site morbidity | Kapur et al. [44] |
BoneSave (TCP/HAp) | 34 patients received uncemented acetabular components (n = 34) and 9 received cemented components (n = 9) | 2 years | BoneSave using mixtures of allograft and BoneSave in impaction grafting were used to assess the effectiveness. | There were no re-revisions and there was no implant migration. Complications were rare (1 fracture, 2 dislocations). Impaction grafting of BoneSave and allograft is an effective method of dealing with loss of bone stock at revision hip surgery in short-term study. | 1 fracture, 2 dislocations | Blom et al. [46] |
BoneSave (TCP/HAp) | 34 patients received uncemented acetabular components (n = 34) and 9 received cemented components (n = 9) | 7 years | Patients were followed up radiographically and with the SAPS, OHS, and SF12 health survey. Kaplan-Meier survivorship analysis was performed with revision of the acetabular component, revision of any part of the construct, and reoperation as endpoints. | 1 patient had been revised for aseptic loosening of the acetabulum and 1 for deep infection. BoneSave is a reliable material for impaction grafting of the acetabulum when used in conjunction with femoral head allograft in medium-term study. | NC | Whitehouse et al. [45] |