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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 56 - 56
1 Dec 2017
Romanò CL Romanò D Scarponi S Logoluso N
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Aim

The treatment of osteomyelitis often requires extensive surgical debridement and removal of all infected tissues and foreign bodies. Resulting bone loss can then eventually be managed with antibacterial bone substitutes, that may also serve as a regenerative scaffold. Aim of the present study is to report the clinical results of a continuous series of patients, treated at our centre with an antibacterial bioglass*.

Method

From November 2010 to May 2016, a total of 106 patients, affected by osteomyelitis, were included in this prospective, single centre, observational study. Inclusion criteria were the presence of osteomyelitis with a contained bone defect or segmental defects < 10 mm, with adequate soft tissue coverage. All patients underwent a one-stage procedure, including surgical debridement and bone void filling with the bioactive glass*, with systemic antibiotic therapy and no local antibiotics. Clinical, radiographic and laboratory examinations were performed at 3, 6 and 12 months and yearly thereafter.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 15 - 15
1 Dec 2016
Morelli I Drago L George D Gallazzi E Scarponi S Romanò C
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Aim

The induced membrane technique (IMT) or Masquelet technique is a two-step surgical procedure used to treat bony defects (traumatic or resulting from tumoral resections) and pseudo arthroses, even caused by infections. The relatively small case series reported, sometimes with variants to the original technique, make it difficult to assess the real value of the technique. Aim of this study was then to undertake a systematic review of the literature with a particular focus on bone union, infection eradication and complication rates.

Method

A systematic review was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Individual Patient Data (PRISMA-IPD) guidelines. PubMed and other medical databases were searched using “Masquelet technique” and “induced membrane technique” keywords. English, French or Italian written articles were included if dealing with IMT employed to long bones in adults and reporting at least 5 cases with a 12 months minimum follow-up. Clinical and bone defect features, aetiology, surgical data, complications, re-interventions, union and infection eradication rates were recorded into a database. Fischer's exact test and unpaired t-test were used for the statistical analysis on the individual patient's data.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_16 | Pages 138 - 138
1 Dec 2015
Malizos K Scarponi S Simon K Blauth M Romanò C
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Infection is among the first reasons for failure of orthopedic implants. Various antibacterial coatings for implanted biomaterials are under study, but only few technologies are currently available in the clinical setting. Previous studies showed the in vitro and in vivo efficacy and safety of a fast resorbable (<96 h) hyaluronic and polylactic acid based hydrogel, loaded with antibiotic or antibiofilm agents (DAC®, Novagenit Srl, Mezzolombardo, TN). Aim of this study is to report the results of the largest clinical trial in trauma and orthopedic patients.

In this prospective, controlled, study, a total of 184 patients (86 treated with internal osteosinthesis for closed fractures and 98 undergoing cementless total hip or knee joint prosthesis) were randomly assigned in three European orthopaedic centers to receive antibiotic-loaded DAC coating or to a control group, without coating. Pre- and post-operative assessment of laboratory tests, wound healing (ASEPSIS score), clinical score (SF-12 score) and x-rays were performed at fixed time intervals. Statistical analysis was performed with Fisher exact test or Student's t test. Significance level was set at p<0.05.

The study was approved by the local Ethical Committee and all patients provided a written informed consent.

On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two-groups at a mean 12 months follow-up (min: 6, max: 18 months).

Four surgical site infections and two delayed union were observed in the control group compared to none in the treated group.

No local or systemic side effects, that could be related to DAC hydrogel coating, were noted and no detectable interference with bone healing or osteointegration could be found

This is the largest study, with the longest follow-up, reporting on clinical results after the use of a fast-resosrbable anti-bacterial hydrogel coating for orthopaedic and trauma implants. Our results show the safety of the tested coating in different indications; although not statistically significant, the data also show a trend towards surgical site infection reduction, as previously demonstrated in the animal models.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_15 | Pages 17 - 17
1 Dec 2015
George D Volpin A Scarponi S Drago L Haddad F Romano C
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The best surgical modality for treating chronic periprosthetic shoulder infections has not been established, with a lack of randomised comparative studies. This systematic review compares the infection eradication rate and functional outcomes after single- or two-stage shoulder exchange arthroplasty, to permanent spacer implant or resection arthroplasty.

Full-text papers and those with an abstract in English published from January 2000 to June 2014, identified through international databases, were reviewed. Those reporting the success rate of infection eradication after a single-stage exchange, two-stage exchange, resection arthroplasty or permanent spacer implant were included, with a minimum follow-up of 6 months and sample size of 5 patients.

Eight original articles reporting the results after resection arthroplasty (n = 83), 6 on single-stage exchange (n = 75), 13 on two-stage exchange (n = 142) and 8 papers on permanent spacer (n = 68) were included.

The average infection eradication rate was 86.7% at a mean follow-up of 39.8 months (SD 20.8) after resection arthroplasty, 94.7% at 46.8 months (SD 17.6) after a single-stage exchange, 90.8% at 37.9 months (SD 12.8) after two-stage exchange, and 95.6% at 31.0 months (SD 9.8) following a permanent spacer implant. The difference was not statistically significant.

Regarding functional outcome, patients treated with single-stage exchange had statistically significant better postoperative Constant scores (mean 51, SD 13) than patients undergoing a two-stage exchange (mean 44, SD 9), resection arthroplasty (mean 32, SD 7) or a permanent spacer implant (mean 31, SD 9) (p=0.029). However, when considering studies comparing pre- and post-operative Constant scores, the difference was not statistically significant.

This systematic review failed to demonstrate a clear difference in infection eradication and functional improvement between all four treatment modalities for established periprosthetic shoulder infection. The relatively low number of patients and the methodological limitations of the studies available point out the need for well designed multi-center trials to further assess the best treatment option of peri-prosthetic shoulder infection.