Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study.

BACKGROUND: Healing of tibia fractures occurs over a wide time range of months, with a number of risk factors contributing to prolonged healing. In this prospective, multicentre, observational study, we investigated the capability of FRACTING (tibia FRACTure prediction healING days) score, calculated soon after tibia fracture treatment, to predict healing time. METHODS: The study included 363 patients. Information on patient health, fracture morphology, and surgical treatment adopted were combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. RESULTS: 319 fractures (88%) healed within 12 months from treatment. Forty-four fractures healed after 12 months or underwent a second surgery. FRACTING score positively correlated with days to healing: r = 0.63 (p < 0.0001). Average score value was 7.3 ± 2.5; ROC analysis showed strong reliability of the score in separating patients healing before versus after 6 months: AUC = 0.823. CONCLUSIONS: This study shows that the FRACTING score can be employed both to predict months needed for fracture healing and to identify immediately after treatment patients at risk of prolonged healing. In patients with high score values, new pharmacological and nonpharmacological treatments to enhance osteogenesis could be tested selectively, which may finally result in reduced disability time and health cost savings.

Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients.

PURPOSE: Several studies have investigated effectiveness of fibrin spray or bipolar sealer to control peri-operative bleeding and reduce the need for blood transfusion, but a direct comparison between the two methods has not been previously performed. We conducted a prospective randomised trial, with standard electrocautery as a control group. METHODS: In our investigation, 95 patients were randomised to one of three parallel groups receiving (1) 10 mL of topical fibrin spray before closure, (2) haemostasis with radiofrequency energy using a bipolar sealer, and (3) standard electrocautery. All patients and staff apart from the surgeons were blinded until data analysis was complete. Peri-operative blood loss has been calculated using a formula described by Ward and Gross (considering estimated patient blood volume, pre- and post-operative haemoglobin and haematocrit levels), with mention of eventual blood re-infusion or transfusion, at given intervals from surgery (6, 24, 48, 72 hours). RESULTS: Mean blood loss was lower for both methods investigated, compared to the control group at every time interval considered, although differences were stronger for fibrin spray [Quixil]. Mean blood saving at the given intervals from surgery (6-24-48-72 hours) was respectively 96 ml, 129 ml, 296 ml, and 121 ml for bipolar sealer [Aquamantys] and 235 ml, 368 ml, 642 ml, and 490 ml for fibrin spray. These results are statistically significant (p = 0.05) for fibrin spray at every interval compared to control values, while a significance is detectable for bipolar sealer only at 48 hours after surgery. CONCLUSIONS: The fibrin spray group had the best performance in terms of blood loss, significantly reduced in comparison with the control group and bipolar sealer group. Blood loss reduction for the bipolar sealer was remarkable only at 48 hours, compared with the control group. Blood loss reduction for fibrin spray was significant at every time interval considered. Differences between the two treatments investigated and the control group narrowed slightly at 72 hours, as an expression of spontaneous homeostasis. Notable is the fact that blood volume saved with fibrin spray at 24 and 48 hours is comparable to the volume of at least one blood unit. A cost-effectiveness analysis should be considered in term of expense, biological risks (related to blood transfusion or human-derived products use) and bleeding-related complications.

Can a combination of different risk factors be correlated with leg fracture healing time?

BACKGROUND: A multicenter retrospective analysis of patients treated for leg fractures was conducted to develop a score that correlates with fracture healing time and to identify the risk gradient for delayed healing. METHODS: Fifty-three patients were analyzed and considered healed when full weight bearing was possible. Patients were divided into those who healed within 180 days and those who took longer to heal. Risk factors associated with delayed healing, fracture morphology, and orthopedic treatments were recorded. The available literature was used to weight the relative risk associated with each factor; values were combined into a score evaluating the risk of delayed healing: L-ARRCO (a literature-based score where the risk of delayed bone healing is calculated using a specific algorithm). Other risk factors associated with delayed healing were then considered in order to calculate a new score, ARRCO. Continuous variables were compared between groups using Student's heteroschedastic two-tail t test. Receiver operating characteristic (ROC) curves and the areas under the curves were calculated to determine the ability of this score to discriminate subjects with delayed healing. RESULTS: The mean L-ARRCO scores of the patients who healed within and after 180 days were significantly different (5.78 ± 1.59 and 7.05 ± 2.46, respectively). The mean ARRCO scores of the patients who healed within and after 180 days were also significantly different (5.92 ± 1.78 and 9.03 ± 2.79, respectively). However, the area under the ROC curve was significantly smaller for L-ARRCO than for ARRCO (0.62 ± 0.09 versus 0.82 ± 0.07). CONCLUSIONS: The ARRCO score is significantly associated with fracture healing time and could be used to identify "fractures at risk," allowing early intervention to stimulate osteogenesis.

Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study.

Pre-clinical studies have shown that treatment by pulsed electromagnetic fields (PEMFs) can limit the catabolic effects of pro-inflammatory cytokines on articular cartilage and favour the anabolic activity of the chondrocytes. Anterior cruciate ligament (ACL) reconstruction is usually performed by arthroscopic procedure that, even if minimally invasive, may elicit an inflammatory joint reaction detrimental to articular cartilage. In this study the effect of I-ONE PEMFs treatment in patients undergoing ACL reconstruction was investigated. The study end-points were (1) evaluation of patients' functional recovery by International Knee Documentation Committee (IKDC) Form; (2) use of non-steroidal anti-inflammatory drugs (NSAIDs), necessary to control joint pain and inflammation. The study design was prospective, randomized and double blind. Sixty-nine patients were included in the study at baseline. Follow-up visits were scheduled at 30, 60 and 180 days, followed by 2-year follow-up interview. Patients were evaluated by IKDC Form and were asked to report on the use of NSAIDs. Patients were randomized to active or placebo treatments; active device generated a magnetic field of 1.5 mT at 75 Hz. Patients were instructed to use the stimulator (I-ONE) for 4 h per day for 60 days. All patients underwent ACL reconstruction with use of quadruple hamstrings semitendinosus and gracilis technique. At baseline there were no differences in the IKDC scores between the two groups. At follow-up visits the SF-36 Health Survey score showed a statistically significant faster recovery in the group of patients treated with I-ONE stimulator (P < 0.05). NSAIDs use was less frequent among active patients than controls (P < 0.05). Joint swelling resolution and return to normal range of motion occurred faster in the active treated group (P < 0.05) too. The 2-year follow-up did not shown statistically significant difference between the two groups. Furthermore for longitudinal analysis the generalized linear mixed effects model was applied to calculate the group x time interaction coefficient; this interaction showed a significant difference (P < 0.0001) between the active and placebo groups for all investigated variables: SF-36 Health Survey, IKDC Subjective Knee Evaluation and VAS. Twenty-nine patients (15 in the active group; 14 in the placebo group) underwent both ACL reconstruction and meniscectomy; when they were analysed separately the differences in SF-36 Health Survey scores between the two groups were larger then what observed in the whole study group (P < 0.05). The results of this study show that patient's functional recovery occurs earlier in the active group. No side effects were observed and the treatment was well tolerated. The use of I-ONE should always be considered after ACL reconstruction, particularly in professional athletes, to shorten the recovery time, to limit joint inflammatory reaction and its catabolic effects on articular cartilage and ultimately for joint preservation.