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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 100 - 100
1 Nov 2021
Papadia D Comincini F Pirchio P Puggioni V Bellanova G
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Introduction and Objective

Management of bone loss associated with bone contamination or infection represents a double biological and clinical challenge frequent in traumatology. The advent of new biomaterials can allow a different approach in the treatment of bone gap. The purpose of this study was to evaluate the prophylactic and therapeutic effectiveness of addition of a new absorbable bone substitute (BS) eluting different antibiotics in reconstruction of bone defects after infections and fractures with soft tissue damage.

Materials and Methods

We conducted a review of patients with contaminated or infected bone defects treated using a new biomaterial, a porous composite of collagen matrices and Beta tricalcium phosphate (β TCP), able to provide a long-term release of different antibiotics. We have included treatment of osteomyelitis and osteosynthesis of exposed fracture (Gustilo Anderson 1–3b) or fractures with soft tissue damage and high risk of contamination. Surgical technique included debridement filling bone defect with BS eluting antibiotics, osteosynthesis (plate, nail, external fixator, kirschner wire), soft tissue coverage, and systemic antibiotic therapy. Radiographic and clinical data including complications (wound dehiscence, superficial or deep infection, osteomyelitis) were collected.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_17 | Pages 51 - 51
1 Dec 2018
Papadia D Odorizzi G Buccelletti F Bertoldi L
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Aim

The optimal treatment of displaced intra-articular calcaneal fractures (DIACF) remains controversial. The operative treatment group has better anatomical recovery, functional outcome scores and less pain than non operative treatment patients, but it may lead to a higher incidence of complications, such as delayed wound healing and surgical site infections. The aim of this study was to analyze the prophylactic effect using a biphasic bone substitute (BS) eluting antibiotic on calcaneal implant-related infections.

Methods

We conducted a retrospective non-randomized review of all patients with DIACF (type Sanders 2, 3, 4) from 2009 to 2017; 103 calcaneal fractures of 90 patients (13 bilaterally) were treated with plates. All cases received the same systemic antibiotic prophylaxis; BS was used on more complex cases with large bone defect and BS was added with antibiotic on higher risk patients. We collected data including complications: major (deep infections, osteomyelitis) and minor complications (wound dehiscence, superficial infection). We considered the absence of deep infections after 6 months. We compared statistically the outcomes of 3 operative groups: the first was treated with plates only (A), the second with plates and BS (B) and the third with plates added with BS eluting antibiotic (vancomicine or gentamicine) (C).


Aim

Open fractures with bone defects and skin lesions carry a high risk of infection potentially leading to prolonged hospitalization and complication requiring revision procedures. Treatment options for diaphyseal fractures with soft tissue lesions are one- or two-stage approaches using external fixation or intramedullary nailing. We describe a surgical technique combining intramedullary nailing with an antibiotic-eluting biphasic bone substitute (BBS) applied both at the fracture site, for dead-space management and infection prevention, and on the nail surface for the prophylaxis of implant-related infection.

Method

Adult patients with an increased risk of bony infection (severe soft tissue damage and open fractures of Gustilo-Anderson grades I and II) were treated with debridement followed by application on the intramedullary nail surface, in the canal and at the fracture site of a BBS with prolonged elution (to 28 days) of either gentamicin or vancomycin. All patients also received systemic antibiotic prophylaxis following surgery. Data on infections and other adverse events were collected throughout the follow-up period. Bone union was determined by radiographic assessment of 4 cortices in radiographs obtained 1 year after surgery.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 47 - 47
1 Jan 2017
Papadia D Dvornik G Bertoldi L
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Bone loss continues to be a clinical and therapeutic problem. Bone reconstruction of osseous defects is a challenge after fracture and traumatic injuries, infections and tumors. The common objective is to regenerate bone morphology and function. Several techniques have been developed to promote bone formation, but the advent of new biomaterials allows us to take an entirely different approach to the treatment of bone voids. However, the use of bone substitutes should be considered carefully, as not all biomaterials behave the same way in humans. Calcium phosphate ceramics are osteoconductive materials that promote bone regeneration. The aim of this study was to retrospectively evaluate the clinical, radiographic and histological results of bone loss treated with an adjunct injectable biphasic bone substitute (BBS).

We analysed the results of patients with fractures and a bone defect that were treated using an injectable BBS (calcium sulfate + hydroxyapatite) and those that were treated using the same bone substitute with antibiotic (gentamicin and/or vancomycin). Patient outcome was evaluated clinically and radiographically. In 9 cases samples for histological analysis were obtained.

From July 2009 to May 2015, 126 cases (cs) on 111 patients (pt) (calcaneus: 53 cs, 47 pt; tibia: 32 cs, 30 pt; Femur: 14 cs, 9 pt, Elbow: 5 cs, 5 pz; humerus 2 cs, 2 pz; wrist 7cs, 7pz; forearm 6 cs, 4 pz; foot 2 cs, 2 pz; Phalanx 5 cs, 5 pt) were treated at our hospital with a BBS. The mean follow-up was 15 months, and bone ingrowth was assessed at 1, 2, 3, 6 and 12 months by X-ray. In all cases, the calcium sulphate phase of the BBS dissolved within 4–6 weeks, and new bone formation was observed at 6 months. On six patients large bone was treated with a revision surgery (autologous cancellous bone graft combined with BBS and antibiotic). No complications were reported.

The 9 histological samples confirmed gradual remodeling and regeneration of the bone substitute over time.

This biomaterial is versatile, offers a good augment for hardware and bone alignment, is biocompatible and osteoconductive, and has allowed us to manage significant bone voids. Histological analysis of samples from the tibia, ulna and calcaneus have confirmed the ability of this bone substitute to remodel into bone.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 38 - 38
1 Dec 2016
Papadia D Musetti A Bertoldi L
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Aim

Open fractures with bone loss and skin lesions carry a high risk of infection and complication. Treatment options are usually a two-stage approach (debridement, temporary stabilization with external fixation followed by open reduction and stabilization with plate). We describe an experience for a single stage procedure with an antibiotic eluting bone graft substitute (BGS) for prophylaxis of implant-related infection.

Method

Between December 2014 and January 2016 were analysed the data of twenty-six patients with open fractures (Gustilo and Anderson grade I and II) or with skin lesion and high risk of contamination and bone loss. They where treated with debridement of soft tissue, closed reduction of fracture, placement of a plate augmented with BGS eluting antibiotic (gentamicin (1) and/or Vancomicin (2)).

Ampicillin and sulbactam 3g three times daily was used as systemic antibiotic prophylaxis minimum for one week. Clinical outcome and radiographic bone defect filling were assessed by blinded observers.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_16 | Pages 30 - 30
1 Dec 2015
Papadia D Musetti A Dematte E
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Open fractures carry a high risk of infection. Our objective was to evaluate the effect of a resorbable bone substitute (BS) (calcium sulphate and hydroxyapatite) eluting Gentamicin (Cerament™| G) in the prevention of bone infection and nonunion after open fracture and/or skin lesion.

The data of patients undergoing osteosynthesis augmented with BS and Gentamicin between December 2012 and April 2015 were retrospectively analyzed from a prospectively established database. Patients were treated for open fractures grade 1 Gustilo or skin lesion with high risk of contamination. Surgical technique included initial debridement, open reduction and internal fixation (ORIF), implantation of BS and Gentamicin, soft tissue closure, and systemic antibiotic therapy for 2 weeks in all cases. Clinical outcome and radiographic bone defect filling were assessed by blinded observers.

From 12/2013 to 4/2015 nine male and six female with mean age 53yrs (24–77) were treated with ORIF and BS and Gentamicin for open fractures. Fracture locations were tibial plateau (two), tibia (two), proximal humerus (one), calcaneus (four), talus (one), forearm (three), and elbow (one) distal femur (one). at final follow-up (mean 11.1 months; range 7–13).

One patient developed a sterile seroma, which was treated conservatively. No post-operative infection occurred during the follow-up period. The calcium sulphate phase of BGS dissolved within 4–6 weeks in all cases.

Bone ingrowth was assessed at 1, 2, 3, 6 and 12 months and new bone formation was observed at 6 months. One patient with an exposed comminuted fracture and large bone defect showed poor bone regeneration and was treated with a revision surgery (exchange of plate, autologous cancellous bone graft combined with BGS and Gentamicin. No complications were reported.

The use of this bone substitute is well documented in the literature. The new product containing 175 mg gentamicin in 10 ml shows a high release of gentamicin in in-vitro testing, comparable to the elution profile of PMMA beads that some authors suggested to use to reduce the risk of infection.

However, the use of this antibiotic carrier in order to prevent bone infection after open fracture has not been studied yet. In this case series 15 patients have been treated and good early clinical outcomes were observed in almost all cases. This material is highly osteoconductive and has a potential for the prophylaxis of infection in the treatment of open fractures. Further investigations and larger series are necessary to show the prophylactic effect in detail.