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Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_15 | Pages 3 - 3
1 Dec 2015
Olesen U Moser C Bonde C Mcnally M Eckardt H
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Treatment of open fractures is complex and controversial.

The purpose of the present study is to add evidence to the management of open tibial fractures, where tissue loss necessitates cover with a free flap. We identified factors that increase the risk of complications. We questioned whether early flap coverage improved the clinical outcome and whether we could improve our antibiotic treatment of open fractures. From 2002 to 2013 we treated 56 patients with an open tibial fracture covered with a free flap. We reviewed patient records and databases for type of trauma, smoking, time to tissue cover, infection, amputations, flap loss and union of fracture. We identified factors thatincrease the risk of complications. We analyzed the organisms cultured from open fractures to propose the optimal antibiotic prophylaxis.

Follow-up was minimum one year. Primary outcome was infection, bacterial sensitivity pattern, amputation, flap failure and union of the fracture.

When soft tissue cover was delayed beyond 7 days, infection rate increased from 27% to 60% (p<0.04). High-energy trauma patients had a higher risk of amputation, infection, flap failure and non-union. Smokers had a higher risk of non-union and flap failure. The bacteria found were often resistant to Cefuroxime, aminoglycosides or amoxicillin, but sensitive to Vancomycin or Meropenem.

Flap cover within one week is essential to avoid infection. High-energy trauma and smoking are important predictors of complications. We suggest antibiotic prophylaxis with Vancomycin and Meropenem until the wound is covered in these complex injuries.

The authors wish to thank Christian E Forrestal for secretarial assistance, spreadsheets and figures, MD Maria Petersen for academic feedback and typography.

Table: Culture results. Depicts the organisms isolated from the wounds, their number N and the number of bacteria that were fully susceptible to antibiotics according to the culture results in falling order on day 2–30 from the trauma. Most organisms were resistant to Cefuroxime. A blank space denotes that the organism was not tested against this antibiotic. A “0” denotes that the organism was not fully sensitive to the antibiotic.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 59 - 59
1 Mar 2012
Moser C Baltzer A Krauspe R Wehling P
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Aims

A new therapy, based on the intra-articular injection of autologous conditioned serum (ACS), is used in several European countries for osteoarthritis (OA) treatment. ACS is generated by incubating venous blood with medical grade glass beads. Peripheral blood leukocytes produce elevated amounts of endogenous anti-inflammatory cytokines such as interleukin-1 receptor antagonist (IL-1Ra) and growth factors that are recovered in the serum(1). ACS has been shown to improve the clinical lameness in horses significantly to enhance the healing of muscle injuries in animal models, and in human athletes. In the present study, the efficacy and safety of ACS was compared to intra-articular hyaluronan (HA), and saline in patients with confirmed knee OA.

Methods

In a prospective, randomised, patient- and observer-blind trial with three parallel groups, 376 patients with knee OA were included in an intention to treat (ITT-) analysis. Efficacy was assessed by patient-administered outcome instruments (WOMAC, VAS, SF-8, GPA) after 7, 13 and 26 weeks (blinded) and Two-years (non-blinded). The frequency and severity of adverse events were used as safety parameters.


Objective: In the absence of dependable and reproducible non-surgical treatment alternatives for osteoarthritis (OA), new approaches are needed. A new therapy, based on the intra-articular injection of autologous conditioned serum (ACS), is used in several European countries. ACS is generated by incubating venous blood with medical grade glass beads. Peripheral blood leukocytes produce elevated amounts of endogenous anti-inflammatory cytokines such as interleukin-1 receptor antagonist (IL-1Ra) that are recovered in the serum(1).

In the present study, the clinical efficacy and safety of intra-articular injections of ACS were compared to intra-articular hyaluronan (HA), and placebo (saline) in patients with confirmed knee OA.

Study Methods: In a prospective, randomized, patient- and observer-blind, placebo-controlled trial with three parallel groups, 399 patient knees with OA were included in an intention to treat (ITT-) analysis. Efficacy was assessed by patient-administered outcome instruments (WOMAC, VAS, SF-8, GPA) after 7, 13 and 26 weeks. The frequency and severity of adverse events were used as safety parameters.

Results: In all treatment groups, intra-articular injections produced a significant reduction in WOMAC-scores and weight-bearing pain (VAS), as well as improvement in health-related quality of life. However, responses to ACS were far stronger. The superiority of ACS and either HA or placebo was statistically significant for all outcome measures and all time points. The mean improvement for patients treated with HA and placebo was half that in the ACS-group (p< 0.001). No significant differences between HA treatment and placebo injections (p> 0,05, at all time points and all outcome measures) were recorded. Frequency of adverse advents (AE) was comparable in the ACS- and the placebo-group (p> 0,05), whereas there were significantly more AE in the HA-group (p< 0,05 for the comparison with ACS and placebo).

Conclusion: Patients with OA of the knee treated by intra-articular injection of ACS showed significantly better clinical improvement during 26 weeks observation compared to patients injected with HA or placebo. The results demonstrate that ACS is highly effective and well tolerated in the management of chronic, idiopathic OA of the knee.

So far, the efficacy of ACS is defined through improvement in clinical signs and symptoms, particularly pain. It remains to be determined whether there are disease-modifying, chondroprotective, or even chondroregenerative, sequelae.