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Table 3 Synthetic scaffolds

From: Scaffolds for the repair of bone defects in clinical studies: a systematic review

Scaffold Case (n = sample) Duration Trial Results Complications Reference
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]