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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 61 - 61
4 Apr 2023
Makaram N Al-Hourani K Nightingale J Ollivere B Ward J Tornetta III P Duckworth A
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The aim of this study was to perform a systematic review of the literature on Gustilo-Anderson (GA) type IIIB open tibial shaft (AO-42) injuries to determine the consistency of reporting in the literature.

A search of PubMed, EMBASE and Cochrane Central Register of Controlled Trials was performed to identify relevant studies published from January 2000 to January 2021 using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The study was registered using the PROSPERO International prospective register of systematic reviews. Patient/injury demographics, management and outcome reporting were recorded.

There were 32 studies that met the inclusion criteria with a total of 1,947 patients (70.3% male, 29.7% female). There were 6 studies (18.8%) studies that reported on comorbidities and smoking, with mechanism of injury reported in 22 (68.8%). No studies reported on all operative criteria included, with only three studies (9.4%) reporting for time to antibiotics, 14 studies (43.8%) for time from injury to debridement and nine studies (28.1%) for time to definitive fixation. All studies reported on the rate of deep infection, with a high proportion documenting union rate (26/32, 81.3%). However, only two studies reported on mortality or on other post-operative complications (2/32, 6.3%). Only 12 studies (37.5%) provided any patient reported outcomes.

This study has demonstrated a deficiency and a lack of standardized variable and outcome reporting in the orthopaedic literature for Gustilo-Anderson type IIIB open tibial shaft fractures. We propose a future international collaborative Delphi process is needed to standardize.


Bone & Joint Open
Vol. 2, Issue 1 | Pages 22 - 32
4 Jan 2021
Sprague S Heels-Ansdell D Bzovsky S Zdero R Bhandari M Swiontkowski M Tornetta P Sanders D Schemitsch E

Aims

Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery.

Methods

The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 57 - 57
1 Sep 2012
Cartner J Hartsell Z Cooper P Ricci W Tornetta III P
Full Access

Introduction

Conventional screws achieve sufficient insertion torque in healthy bone. In poor bone screw stripping can occur prior to sufficient torque generation. It was hypothesized that a screw with a larger major/minor diameter ratio would provide improved purchase in poor bone as compared to conventional screws. We evaluated the mechanical characteristics of such a screw using multiple poor bone quality models.

Methods

Testing groups included: conventional screws, osteopenia screws used in bail-out manner (ie, larger major/minor diameter screws inserted into a hole stripped by a conventional screw), and osteopenia screws used in a preemptive manner (ie, no screw stripping occurrence).

Stripping Torque: Screws were inserted through standard straight plates into a low density block of foam with a predrilled hole. Stripping torque was defined as maximum insertion torque reached by the screw before the screw began to spin freely in the foam.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 575 - 575
1 Nov 2011
Bhandari M Kooistra BW Busse J Walter SD Tornetta P Schemitsch EH
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Purpose: We aimed to preliminarily validate a newly developed system, the radiographic union scale for tibial (RUST) fracture healing. We hypothesized that RUST would demonstrate better inter-rater reliability than assessment of the number of cortices bridged and correlate with functional outcomes at least as strongly as surgeon’s assessment of cortical bridging.

Method: Three blinded orthopaedic trauma surgeons independently assigned a RUST score and a number of cortices bridged by callus (zero to four) to each set of AP and lateral radiographs at each follow up period. RUST is scored from four (definitely not healed) to 12 (definitely healed) based on the presence or absence of callus and of a visible fracture line at the total of four cortices visible.

Results: For 549 sets of reviewed radiographs, inter-rater reliability for RUST scores were found to be substantially higher than for assessment of the number of cortices bridged (intra-class correlation coefficient=0.84; 95% CI, 0.80–0.87 versus kappa = 0.73; 95% CI, 0.64 – 0.81, respectively). Both methods of assessing radiographic healing were strongly correlated with weight-bearing status (r and ρ> 0.50), moderately correlated with patient-reported functional recovery and the SF-36 Physical Functioning component scores (r and ρ> 0.30), and minimally correlated with HUI Mark II scores, return to work, and the SF-36 Role Physical component and Physical Component Summary scores (r and ρ> 0.10). Neither assessment was correlated with patient-reported pain scores. All correlations were similar for RUST and the number of cortices bridged.

Conclusion: This study provides preliminary evidence that RUST can be used as a valid and reliable alternative assessment of tibial fracture healing.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 26 - 26
1 Mar 2010
Tornetta P Siegel J Burke P Kaseje N Agarwal S Soto J Anderson S
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Purpose: In patients with pelvic trauma, the need to quickly and accurately rule out sources of bleeding is paramount. We sought to determine the predictive value of CT angiography in determining the need for therapeutic angiography and to ascertain if definable arterial bleeding correlated with anatomic injury.

Method: Over a 2 year period 58 patients with a high-energy mechanism and pelvic injury underwent pelvic CT angiography as part of their initial trauma CT scan. This was performed as a 25 second delayed scan (after contrast introduction) using a GE light speed VCT64 scanner. The decision to proceed to therapeutic angiography was made on clinical grounds and was later compared with the CT angiographic findings. The anatomic location of bleeding on CT angio and interventional angio were compared.

Results: There were 36 male and 22 female patients, aged 43 (17 – 86), with average ISS of 18.6. The 18 (31%) patients with positive extravasation on CT angiography had higher initial blood requirements compared to those without extravasation. Two of the CT(+) group died prior to therapeutic angiography being performed. 11 of the remaining 16 had interventional angiography; 8 had (+) findings, including 7 major vessels coiled and 1 cutoff vessel observed. 1 patient of 40 with negative CT angiogram met clinical criteria had an interventional angiography; no arterial bleeding was discovered. The negative predictive value of CT angiography for pelvic arterial bleeding requiring therapeutic angiography was 100%; the positive predictive value of angiographically treatable bleeding was 70% (counting the two early deaths). The vessel location on CT angio and therapeutic angio was consistent in all cases. The CT angio (+) group had a higher percentage of unstable pelvic injuries (67% vs. 40%).

Conclusion: In this pilot study, CT angiography added to the initial trauma scan in patients with pelvic trauma demonstrated a 100% NPV for arterial bleeding that required therapeutic angiography on clinical grounds. Positive findings correlated well with the anatomic location of pelvic injury and had a 70% PPV for angio-graphically treatable bleeding. Further study of this technique is warranted.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 27 - 27
1 Mar 2010
Tornetta P Freeman A Schmidt A Bechtold J Ricci W Flemming M
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Purpose: Locked plating has become a commonly used technique in complex fracture and nonunion work. The combination of locked and unlocked screws in the same construct has been referred to as “hybrid” fixation. Little work is available to direct the specifics of this fixation method. The purpose of this study was to determine the relative contribution of the number and location of locked screws on the properties of hybrid plate constructs in an osteoporotic bone model.

Method: A prefabricated osteoporotic model was used for reproducibility (composite cylinders 35 mm in diameter and consisting of a 2.5 mm fiberglass shell filled with 10 lb/ft3 polyurethane). A 5mm gap model was used, and fixed with a 12 hole plate. Six different constructs were tested including 2 unlocked and 4 hybrid configurations. All screws were bicortical and placed with 4Nm of torque. Baseline removal (loosening) torque was recorded for each screw for comparison with removal torque after cyclic loading. Testing was performed with ±8Nm of torsional load and run to 100,000 cycles. Stiffness of each construct was measured at 10,000 cycle increments and the removal torque of each screw was recorded at the conclusion of the 100,000 cycles.

Results: Stiffness of the constructs was most affected by the number of screws. No effect was seen with the replacement of one or two unlocked screws with locked screws on each side of the gap. Replacement of three unlocked screws with locked screws increased the stiffness of the construct (p< 0.001).

Conclusion: At least three bicortical locked screws on each side of a construct are needed to increase the stiffness and decrease the loss of stiffness over 100,000 cycles of torsional stress in an osteoporotic surrogate model. Locked screws placed between the fracture and unlocked screws protect the unlocked screws from loosening and may have some clinical utility in fatigue of the construct.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 20 - 20
1 Mar 2010
Tornetta P Ricci W Russell T Jones B Petteys T Gerlach D
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Purpose: Many lateral malleolar fractures in patients with osteoporotic bone are rotationally unstable, requiring fixation stable in torsion with good fatigue properties, but without bulk due to the soft tissue constraints. The purpose of this study was to evaluate the torsional performance of a thin (1.5mm) plate with locked and non-locked constructs in a simulated osteoporotic lateral malleolus fracture.

Method: A transverse fracture gap to mimic comminution was created in (15 lb/ft3) density foam. 3 bicortical unlocked screws were used proximal to the fracture in a 5 hole thin (1.5mm) plate for both constructs. Distally, two screws that did not breach the far cortex (12mm) were placed as locked in one group and unlocked in the other. The constructs were loaded in torsion at 1 Hz at 7.5/0.75 in-lbf (0.85/0.08 N-m) of torque. A torsional fatigue failure was defined as either a fracture of the plate, screw pull-out, or construct rotation 10 degrees beyond the maximum initial rotational displacement. Testing was conducted until construct failure or run-out of 300,000 cycles.

Results: The thin plate constructs with locked distal screws showed significantly improved fatigue properties (p< 0.00001). None of the locking plate constructs failed prior to the 300,000 cycle end point. In stark contradistinction, all of the non-locked contructs failed at an average cycle count of only 9,541 (range 1,000 – 23,000 cycles). The failure mode for each of the non-locked constructs was pull-out of the distal screws.

Conclusion: These results indicate that the use of a thin plate with locking capability provides a significant advantage over non-locked constructs in fatigue performance in areas of poor bone density subjected to torsional loads, such as the lateral malleolus.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 237 - 237
1 May 2009
Bhandari M Siegel J Sung J Tornetta P
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We aimed to quantify the sample sizes and magnitude of treatment effects in a review of orthopaedic randomised trials with statistically significant findings.

We conducted a comprehensive search (PubMed, Cochrane) for all randomised controlled trials between 1/1/95 to 12/31/04. For continuous outcome measures (ie functional scores), we calculated effect sizes (mean difference/standard deviation). Dichotomous variables (ie infection, nonunion) were summarised as absolute risk differences and relative risk reductions (RRR). Effect sizes > 0.80 and RRRs> 50% were defined as large effects.

Our search yielded 433 RCTs, of which 76 RCTs with statistically significant findings on 184 outcomes (122 continuous/62 dichotomous outcomes) met study eligibility criteria. The mean effect size across studies with continuous outcome variables was 1.7 (95% confidence interval: 1.43–1.97). Almost one in three results, despite being reported as statistically significant did meet the definition of a large effect size (ES< 0.80). For dichotomous outcomes, the mean risk difference was 30% (95%confidence interval:24%–36%) and the mean relative risk reduction was 61%.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 42 - 42
1 Mar 2008
Bhandari M Devereaux P Swiontkowski M Tornetta P Obremskey W Koval K Sprague S Schemitsch E Guyatt G
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In a meta-analysis of fourteen trials (N=1901 patients) in patients with displaced hip fractures, we identified significant reductions in the risk of revision surgery with internal fixation compared to arthroplasty. A trend towards increased mortality with arthroplasty was identified.

The purpose of this study was to determine the effect of arthroplasty (hemi-arthroplasty, bipolar arthroplasty and total hip arthroplasty) in comparison to internal fixation for displaced femoral neck fractures on rates of mortality and revision surgery

Arthroplasty for displaced femoral neck fractures, in comparison to internal fixation, significantly reduces the risk of revision surgery at the cost of greater infection rates, blood loss and operative time, and a possible increase in early mortality.

Over 220,000 fractures of hip occur per year in North America representing an annual seven billion dollar cost to the health care system. Current evidence suggests internal fixation may reduce mortality risk at the consequence of increased revision rates. A large trial is needed to resolve this issue.

We searched computerized databases (MEDLINE, COCHRANE and SCISEARCH) for published clinical studies from 1969–2002 and identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic texts and personal files. We found a non-significant trend toward an increase in the relative risk of dying with arthroplasty when compared to internal fixation (relative risk=1.27, 95% confidence interval, 0.84–1.92, p = 0.25; homogeneity p= 0.45). Arthroplasty appeared to increase the risk of dying when compared to pin and plate, but not in comparison to internal fixation using screws (relative risk= 1.75 vs 0.86, respectively, p< 0.05). Fourteen trials provided data on revision surgery (n=1901 patients). The relative risk of revision surgery with arthroplasty was 0.23 (95% confidence interval, 0.13–0.42, p = 0.0003, homogeneity p = < 0.01).


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 74 - 74
1 Mar 2008
Leighton R Russell T Bucholz R Tornetta P Cornell C Goulet J Vrahas M O’Brien P Varecka T Ostrum R Jackson W Jones A
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This prospective randomized multicenter study compares two methods of bone defect treatment in tibial plateau fractures: a bioresorbable calcium phosphate paste (Alpha-BSM) that hardens at body temperature to give structural support versus Autogenous iliac bone graft (AIBG).

One hundred and eighteen patients were enrolled with a 2:1 randomization, Alpha-BSM to AIBG. There was a significant increased rate of non-graft related adverse affects and a higher rate of late articular subsidence (three to nine month period) in the AIBG group.

A bioresorbable calcium phosphate material is recommended in preference to the gold standard of AIBG for bone defects in tibial plateau fractures.

This prospective randomized multicenter study was undertaken to compare two methods of bone defect treatment: a bioresorbable calcium phosphate paste (Alpha-BSM –DePuy, Warsaw, IN) that hardens at body temperature to give structural support and is gradually resorbed by a cell-mediated bone regenerating mechanism versus Autogenous iliac bone graft (AIBG).

One hundred and eighteen adult acute closed tibial plateau fractures, Schatzker grade two to six were enrolled prospectively from thirteen study sites in North America from 1999 to 2002. Randomization occurred at surgery with a FDA recommendation of a 2–1 ratio, Alpha BSM (seventy-eight fractures) to AIBG (forty fractures). Only internal fixation with standard plate and screw constructs was permitted. Follow-up included standard radiographs and functional studies at one year, with a radiologist providing independent radiographic review.

The two groups exhibited no significant differences in randomization as to age, sex, race, fracture patterns or fracture healing. There was however, a significant increased rate of non-graft related adverse affects in the AIBG group. There was an unexpected significant finding of a higher rate of late articular subsidence in the three to nine month period in the AIBG group.

Recommendations for the use of AIBG for bone defects in tibial plateau fractures should be discouraged in favor of bioresorbable calcium phosphate material with the properties of Alpha BSM. We believe further randomized studies using AIBG as a control group for bone defect support of articular fractures are unjustified.

A bioresorbable calcium phosphate material is recommended in preference to the gold standard of AIBG for bone defects in tibial plateau fractures.

Funding: DePuy, Warsaw, IN.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 107 - 107
1 Mar 2008
Bhandari M Tornetta P
Full Access

Risk information is understood differently when it is presented in absolute or relative terms; the latter overemphasizes the magnitude of risk. How surgeons communicate risk may influence patient choice. We evaluated whether presenting information about the benefits of surgery in absolute and relative terms affects an individual’s decision to accept or reject alternative surgical procedures in hip fracture management. Our findings show how framing risk in relative terms affects the perception of risk and influences patient choice. Surgeons must use care in utilizing relative risk reduction in the absence of actual risk data.

Risk information is understood differently when it is presented in absolute or relative terms; the latter overemphasizes the magnitude of risk. How surgeons communicate risk may influence patient choice.

To evaluate whether presenting information about the benefits of surgery in absolute and relative terms affects an individual’s decision to accept or reject alternative surgical procedures in hip fracture management.

We administered a face-to-face survey to fifty patients attending the fracture clinic. We asked patients to consider a scenario and to decide which treatment alternative they preferred based upon risk presentation. We presented risk in five ways: absolute risk difference, relative risk reduction, relative risk, number needed to treat, and odds ratio.

Patients were most likely to favor internal fixation when the mortality results comparing internal versus arthroplasty were presented as a relative risk reduction. Patients continued to favor internal fixation despite being presented with a significantly increased risk of revision surgery. Lower level of education and those patients who had not experienced a fracture were significantly associated with their perceptions about method of presentation.

Our findings show how framing risk in relative terms affects the perception of risk and influences patient choice. Patients concerns about mortality, even if non-significant differences are presented, outweigh concerns about significant increases in revision surgery with internal fixation. Surgeons must use care in utilizing relative risk reduction in the absence of actual risk data given our findings that may over-estimate the relative benefits of one procedure over another.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 32 - 32
1 Mar 2006
Tsiridis E Kain M Song M Bancroft J Rene J Kakar S Morgan E Gerstenfeld L Tornetta P Einhorn T
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Background: Metaphyseal fracture healing presents special biomechanical challenges in orthopaedic surgery. The void typically created by damage to the metaphyseal cancellous bone must usually be filled in order to recover the biomechanical integrity of the bone. While autologous bone grafting is a standard treatment for these fractures, bone graft substitutes delivered with or without pharmacologic agents may augment healing.

Hypothesis: Tricalcium phosphate (TCP) is a known osteoconductive bone filler and OP-1 an osteoinductive bone morphogenetic protein; both have been used in the past in diaphyseal fractures with success. PTH (parathyroid hormone) has been recently shown to enhance osteoblastic activity, to have a net anabolic effect on bone mass, and to enhance healing of diaphyseal fractures. Each of these agents may also enhance healing of metaphyseal fractures.

Objective: The potential of all above factors to accelerate metaphyseal fracture healing has been evaluated in a new metaphyseal fracture model developed in our laboratory in a rabbit model.

Material and Methods: A metaphyseal wedge osteotomy was created in the distal tibia of 16-week-old female New Zealand White rabbits (n=20). The osteotomy was bridged with a custom-made external fixator. The osteotomy gap was filled with TCP containing OP-1 (n=4), TCP alone with daily subcutaneous injections of 10μg/Kgr BW PTH (n=4), or TCP alone with daily subcutaneous administration of 40μg/Krg BW PTH (n=4). Two control groups, TCP alone (n=4) and normal healing (n=4), were also included. Assessment methods included biomechanical testing in both compression and torsion, radiographic examination, and QCT scans.

Results: Healing was observed in both PTH treated groups as well as in the OP-1 group at 4 weeks post-surgery. PTH appeared to have a systemic effect on bone formation, whereas the effect of OP-1 was local to the osteotomy site. In comparison, healing was delayed in the normal healing and TCP alone groups.

Conclusion: PTH and OP-1 both enhance metaphyseal fracture healing. The different systemic vs. local effects of these two agents, suggest that PTH and OP-1 may have potential synergism in accelerating healing of metaphyseal fractures.