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CERTIFy - Cerament Treatment of Fracture Defects: A prospective, multicenter, randomized study investigating the use of CERAMENT™|BONE VOID FILLER as bone graft substitute in Tibia Plateau Fractures

Laufzeit: 01.01.2012 - 31.12.2014

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Kurzfassung


Standard treatment procedure for unicondylar tibia plateau fractures:
The knee joints are inspected for fracture patterns and damage of the meniscus and ligaments. Impaction fractures are usually treated by elevating the fragments from below with a bone impactor introduced either through the fracture or through a small cortical window. The remaining bony defect is filled with autologous cancellous bone graft from the ipsilateral iliac crest, supported by screw fixation through a buttress...
Standard treatment procedure for unicondylar tibia plateau fractures:
The knee joints are inspected for fracture patterns and damage of the meniscus and ligaments. Impaction fractures are usually treated by elevating the fragments from below with a bone impactor introduced either through the fracture or through a small cortical window. The remaining bony defect is filled with autologous cancellous bone graft from the ipsilateral iliac crest, supported by screw fixation through a buttress plate.

Co-morbidities from autologous bone graft donor sites:
The use of autograft bone is the best option when undertaking a procedure that requires bone graft because it is osteogenic, osteoconductive and osteoinductive. The iliac crest is the most frequently used site for bone-graft harvest and remains to be the 'gold standard'. The most common complication associated with the harvest of autologous bone graft is pain at the donor site; with less frequent complications including nerve injury, hematoma, infection, and fracture at the donor site, occurring in between 6% and 30% of the cases. Decreased quality of life has been reported in patients after iliac crest harvesting. Prolonged operation time and prolonged hospital stay are also commonly reported due to the additional surgical procedure and post-operative pain.

Alternatives to autologous bone grafting in the treatment of Tibia Plateau Fractures:
The products now approved as alternatives to autologous bone grafts are those based on naturally occurring materials (e.g., demineralized human bone matrix, bovine collagen mineral composites, and processed coralline hydroxyapatite) as well as synthetic materials (e.g., calcium sulfate pellets, bioactive glass and calcium phosphate cement).

Especially Calcium Phosphate Cements (CPC) have been investigated as bone graft substitutes. In a non-controlled, non-standardized cohort study bone union was achieved in all patients with a mean follow-up of 22.2 months (range 6 – 32 months), and at the latest follow-up graft resorption was observed in 89% of the knees judged by plain radiographs. A non-randomized, comparative study found better anatomical results in the group treated with CPC than in the group treated with conventional bone grafts,(9) and in a prospective, randomized study with 119 patients with tibia plateau fracture treated with calcium phosphate cement or autologous iliac bone graft. They found comparable results in the two groups, apart from a higher rate of subsidence in the bone graft group. Other studies have looked at the same and all with focus on clinical and functional outcome.
Bioactive glass has been compared to autologous bone in a randomized clinical study for the treatment of tibia plateau fractures. This study with 25 patients found the same clinical outcome in the two groups. Allogeneic frozen bone grafts have been investigated in a non-controlled cohort study showing good functional outcome and integration of the graft. None of the published studies looked at pain, quality of life (QoL), or cost of care.

Conclusion:
The co-morbidities related to harvesting of autologous bone grafts are well documented. A clinical/functional outcome when comparing the use of autologous bone graft with the use of a bone graft substitute has been investigated in several studies. However, the endpoints looked at in these studies were strongly related to the quality of the surgery performed and much less to the category of bone graft material used. No studies have compared pain, QoL, and cost of care, which are all relevant endpoints related to the category of the bone graft used. This makes it highly needed to investigate these outcomes in a sufficiently powered, prospective, randomized, controlled clinical trial.
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