We need to shift our focus to integrating sex and gender into research proposals, so we can answer some of the most basic unanswered questions in the field of fracture management. Current evidence in guidelines indicate a near-to-linear increase from the 1990s for inclusion of sex and gender. However, these recommendations remain expressed in absolute terms, with little explanatory power, affecting uptake and implementation in clinical practice. This co-branded session, with members of the Orthopaedic Research Society – International section of fracture repair (ORS-ISFR), will provide participants with guiding principles and tools to assist researchers and grant reviewers understand what it means to include sex and gender in meaningful ways: from formulating research questions, recruitment strategies, to conducting sex-stratified analyses. In this presentation, we will consider diverse approaches, methods and, analyses to elevate sex and gender within trauma. A strong emphasis on the ways and means of including marginalized and vulnerable populations in research will be addressed.

Introduction

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We report on the progress on establishing a minimal set of core domains for outcome measurement in distal radius fracture.

Introduction

There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment.

Background: Hip fracture trials have employed a wide range of patient-reported outcomes (PRO) suggesting a lack of consensus among clinicians on what are considered the most relevant outcomes. Variability in functional outcome reporting in hip fracture management creates challenges in the comparison of results across trials. The purpose of this study was to conduct a systematic review of the functional outcomes fielded in randomized controlled trials in post-operative hip fracture treatment for the aged. We hypothesized that over time there had been an increase in patient-reported outcomes along with aggregate scoring systems of hip function.

Methods: An electronic database search was conducted using key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. s and titles were screened in duplicate and independently. All of the articles that met eligibility criteria were reviewed using the 21-point Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scored > 75% in quality. Out of 86 trials, 8 (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 12 trials used the same composite score: 12 (13.9%) ADL Katz Index, 9 (10.4%) trials used the HHS and 8 (9.3%) trials used Parker’s mobility score.

Conclusion: Although in the past decade more studies have made use of outcome instruments that capture both impairment and functional status in one aggregate score, there is a lack of standardized assessment.

Background: The literature on hip fractures is increasingly reporting patient-reported outcomes along with aggregate scoring systems. However, this rapid growth in the number and types of patient-based outcomes can be confusing. The purpose of this paper is to conduct a systematic review of the functional outcome instruments fielded in high quality randomized clinical trials evaluating postoperative hip fracture management and rehabilitation in the aged.

Methods: An electronic database search was conducted using a variety of key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. Abstracts and titles were screened in duplicate and independently. Studies were eligible based on the following criteria: hip fracture, randomized controlled trial, mean age of 65 years, and in the English language. Studies were excluded based on the following criteria: inclusion of fractures other than hip, minimum age of patient enrolment < 50 years old and prevention or fracture risk reduction as primary outcome of study. All of the articles that met eligibility criteria were reviewed using the Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). Discordance was resolved by consensus. The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). Data was abstracted from the 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scoring > 75% in quality. Surgical trials had 16.7% more measures of disability than measures of impairment. Furthermore, 70% of the surgical trials used composite scores when compared to either medical or rehabilitation trials. Eight trials (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 10 trials used the same composite score: 10 (16,9%) ADL Katz Index, 9 (15.2%) trials used the Harris hip score and 5 (8.5%) trials used Parker’s mobility score.

Discussion/Conclusion: Although there is a trend towards studies assessing functional recovery as a primary outcome in the aged with hip fractures, none of the measures were used consistently. A lack of standardized assessment in these groups of patients will overestimate treatment effects.

PURPOSE: The treatment of pertrochanteric fractures is constantly evolving and surgical issues remain controversial. Although the use of a sliding hip screw is considered to be the treatment of choice by many surgeons, we believe that intramedullary nailing could be a viable treatment option for unstable pertrochanteric fractures. Given this background, we compared the clinical outcome of unstable pertrochanteric fractures treated with intramedullary hip screw (IMHS) and standard screws with unstable pertrochanteric fractures treated with intramedullary hip screw using hydroxyapatite (HA)-coated screws.

METHODS: Forty consecutive female osteoporotic patients with pertrochanteric fractures were selected. The inclusion criteria were: female; age ≥65 years; pertrochanteric fracture resulting from minor trauma. Patients were randomized by a computer-generated list to receive either IMHS fixed with stainless steel lag screws (Group A) or IMHS fixed with HA-coated pins (Group B).

RESULTS: Average patient age was 82 ± 8 years in Group A and 78 ± 6 years in Group B. Average BMD was 512 ± 177 in Group A, and 471 ± 231 in Group B. Average intraoperative time was 64 ± 6 minutes in Group A and 34 ± 5 minutes in Group B (p < 0.005). In Group A, all patients had post-operative blood transfusions averaged 2.0 ± 0.1. In Group B, there were no blood transfusions (p < 0.0001). In Group A, the reduction over time in the femoral neck-shaft angle was 6 ± 8, while in Group B, the reduction was 2 ± 1 (p < 0.002).

Conclusion: This study showed that intramedullary hip screw with HA-coated lag screw is an effective treatment for unstable fractures in this patient population. The operative time is brief, the fixation is adequate, and the reduction is maintained over time.

Introduction: Pin loosening is a common complication associated with external fixation. Various attempts such as coating the pins with calcium phosphates, have been made to modify the pin surface in order to reduce pin loosening and provide good fixation. Animal and clinical studies showed that fixation using tapered external fixation pins coated with hydroxyapatite is superior to standard pins. However, there is no data on cylindrical pins either fully or partially coated with HA. A partial coating could be a solution to optimize pin fixation with the advantage of easier removal compared to fully coated pins. Our purpose was to compare standard and partially coated cylindrical Apex pins implanted in a sheep model at 2 and 6 weeks. As controls we included fully coated tapered pins.

Materials/Methods: Five groups of pins were studied. Group A included standard cylindrical Apex pins implanted in sheep which were euthanized 2 weeks after surgery; Group B included partially coated Apex pins implanted in sheep which were euthanized 2 weeks after surgery; Group C included tapered pins fully coated with HA implanted in sheep which were euthanized 2 weeks after surgery; Group D included Standard Apex pins implanted in sheep which were euthanized 6 weeks after surgery; Group E included partially coated Apex pins implanted in sheep which were euthanized 6 weeks after surgery. With the tapered pins, full contact between the coated surface and both cortices was obtained. After pin implantation, a unilateral external fixator was mounted onto the pins (Stryker carbon blue monotube Ø 20/250mm). A 5mm long removal osteotomy was performed in the mid-part of the tibial diaphysis, so that 3 pins were situated above the gap and 3 below to ensure load transfer through the bone-pin interface. Extraction torque and tibial torque resistance and histological analyses were obtained after pin removal.

Results: At 2 weeks, mean insertion torque was significantly higher for group C compared to group A (p = 0.03). Mean extraction torque was statistically higher for group B compared to group A (p = 0.001). A statistically significant difference was found in the Pettine index (p = 0.03) between groups A and B. At 6 weeks, no differences in extraction torque were seen.

Discussion: We believe that the partial application of the coating reduced the potential for osteointegration and the ultimate fixation of the coated Apex pins.

Introduction: Screw loosening is a common complication of osteoporotic fracture fixation leading to implant loosening, fracture malunion and non-union. Because recent animal studies have shown that bisphosphonates improve implant fixation we wanted to assess whether alendronate (ALN) improves screw fixation in a clinical setting of osteoporotic fractures.

Methods: Sixteen consecutive patients with AO/OTA A1 pertrochanteric fractures were selected. Inclusion criteria were: female over the age of 65, BMD T-score less than −2.5 SD. Fractures were fixed with a pertrochanteric fixator and 4 hydroxyapatite (HA)-coated screws. Two screws were implanted in the femoral head (screw positions 1 and 2) and two in the femoral diaphysis (screw positions 3 and 4). Patients were randomized to either postoperative systemic administration of ALN, 70 mg per week for 3 months (Group A) or no ALN. Fixators were removed at 3 months post-op in all patients.

Results: All the fractures healed. No differences in screw insertion torque between the two groups were found. No pin loosening or infection occurred. The combined mean extraction torque of the screws implanted at positions 1 and 2 (cancellous bone) was 3181 ± 1385 N/mm in Group A and 1890 ± 813 N/mm in Group B (p < 0.001). The combined mean extraction torque of the screws implanted at positions 3 and 4 (cortical bone) was 4327 ± 1720 N/mm in Group A and 3785 ± 1181 N/mm in Group B (ns).

Discussion and Conclusion: This is the first study to demonstrate in a clinical setting improved screw fixation following post-operative ALN treatment. We observed a two-fold fixation increase in the screws implanted in cancellous bone. With cortical bone, the difference in screw fixation was less marked. Besides its bone preserving ALN should be recommended as an effective solution to improve fixation in osteoporotic bone.

INTRODUCTION: This prospective randomized study investigated short-term outcomes of cemented vs. HA-coated hip arthroplasty in elderly osteoporotic patients with femoral neck fractures.

METHODS: Forty consecutive patients with femoral neck fractures (AO/OTA fracture type B2 and B3) were randomized to receive either an AHS prosthesis (Group A, n = 22, cemented implant) or a Furlong prosthesis (Group B, n = 18, HA-coated implant). Inclusion criteria were: female age ≥75, fracture resulting from minor trauma, ability to communicate and bone mineral density (BMD) T-score at the contralateral hip lower than −2.5 SD. Subjective assessment was evaluated according to a rating system 0-(unsatisfactory) to 10(satisfactory). Average follow-up was 29 months for Group A and 27 months for Group B.

RESULTS: Average patient age was 75 ± 5 in both groups. There were no differences in ASA scores between the two groups. Surgical time was 77 ± 12 minutes for Group A, and 72 ± 13 minutes for Group B (ns). Harris hip score was 46 ± 36 in Group A and 62 ± 33 in Group B. (p < 0.05). SF-36 was 35 ± 32 in Group A and 54 ± 32 in Group B (ns). Subjective assessment was 5 ± 4 in Group A and 7 ± 3 in Group B (ns). The incidence of death during the follow-up period was 33% in Group A and 15% in Group B. (p < 0.05). One Group A patient underwent revision due to implant loosening. A Furlong prosthesis was successfully implanted in this patient.

DISCUSSION: Although femoral neck fractures in elderly osteoporotic patients are usually treated with cemented arthroplasty, our comparative study showed better results with the Furlong prosthesis, even if statistical significance was reached in only two parameters. The outcomes obtained with the Furlong prosthesis are due to the ability of the HA-coating to bind with osteoporotic bone, thus establishing a stable fixation. Fixation failed in only one cemented implant, but our case number was limited and the follow-up short. Post-op mortality at the time of follow-up was high. This was not unexpected, given the age level and health status of the study groups. This study shows that the HA-coated Furlong prosthesis is a viable option for the treatment of elderly osteoporotic femoral neck fracture patients.

Purpose: Four external fixation pin types differing in coating, design and implantation technique were tested in an animal study.

Methods: Forty tapered pins were divided into 4 Groups according to pin design type: Group A consisted of 10 standard self-tapping pins (ø5–6mm, pitch 1.75mm), Group B 10 hydroxyapatite (HA)-coated self-tapping (ø5–6mm, pitch 1.75mm), Group C 10 standard, self-drilling, self-tapping (ø5–6mm, pitch 1.25mm) and Group D 10 HA-coated, self-drilling, self-tapping (ø5–6mm, pitch 1.25mm). Four pins were randomly implanted into the femoral diaphysis of 10 sheep. The pins were implanted at 2-cm intervals apart. Pre-drilling was used for Groups A and B but not for Groups C and D. Sheep were euthanized 6 weeks after surgery.

Results: There were no major complications. Mean pin insertion torque was 3100 ± 915 Nmm in Group A, 2808 ± 852 Nmm in Group B, 2589 ± 852 Nmm in Group C and 2180 ± 652 Nmm in Group D. Mean pin extraction torque was 1570 ± 504 Nmm in Group A, 2128 ± 1159 Nmm in Group B, 1599 ± 809 Nmm in Group C and 2200 ± 914 Nmm in Group D. Insertion torque of the coated groups was lower than insertion torque of the standard groups (p < 0.05). However, extraction torque of Groups B and D was higher than Groups A and C (p < 0.05). No differences in pin fixation were found between the two coated pin groups (Group B and D). Morphologic analysis showed extensive bone to pin contact without fibrous tissue interposition in the coated pin groups and fibrous tissue interposition in the uncoated pin groups.

Conclusion/Significance: This study demonstrated that coating pins with hydroxyapatite is effective regardless of the pin design and the implantation technique.

Introduction: Deterioration of bone-pin interface, causing pin loosening and infection, is a major cause of postoperative complications following external fixation. This paper presents the results obtained using hydroxyapatite (HA)-coated pins in various bone types, such as osteoporotic bone.

Materials And Methods; In an animal study comparing HA-coated and standard pins, pin insertion and extraction torque were measured. Subsequently, a clinical study compared insertion, extraction torque and pin-tract infection rate of standard and HA-coated pins implanted in healthy and osteoporotic bone.

Results: hi the animal study, mean final insertion torque was 4360±1050Nmm in the standard group and 3420 ± 676 Nmm in the HA-coated group. Mean extraction torque was 253 ± 175 Nmm in the standard group and 3360 ± 1260 Nmm in the HA-coated group (p = 0.002). In the clinical study on healthy bone, the mean insertion torque was 4130 ± 2160 Nmm in the standard group and 3440 ± 1930 Nmm in the HA-coated group (p = 0.03). The mean extraction torque was 1470 ± 1700 Nmm in the standard group and 5130 ± 2300 Nmm in the HA-coated group (p < 0.001). There were 33 pin-tract infections in the standard group and 20 pin-tract infections in the HA-coated group (p < 0.05, power 0.9). The standard pin group had a mean extraction torque of 730 (0–5500) Nmm in the infected pin-tracks and 2110 (0–7000) Nmm in the uninfected pin-tracts (p < 0.0001). The HA-coated group had a mean extraction torque of 5310 (1000–8000) Nmm in the infected pin-tracts and 5080 (0–8000) Nmm in the uninfected pin tracts (NS). In the clinical study on osteoporotic bone, mean final insertion torque was 461 ± 254 Nmm in the standard group and 331 ± 175Nmm in the HA-coated group (p = 0.01). Mean extraction torque was 191 ± 154 Nmm in the standard group and 600 ± 214 Nmm in the HA-coated group (p < 0.0005). Pin infection rate was greater in the standard group (p < 0.05).

Conclusion: There was no deterioration of the bone-pin interface strength (measured by torque resistance at the time of pin extraction) with HA-coated pins. The improved strength of fixation of the HA-coated pins was associated with a lower incidence of pin-tract infection.

Although dynamic hip screw (DHS) is considered the treatment of choice for pertrochanteric fractures, we theorized that external fixation would produce clinical outcomes equal to, if not better than, outcomes obtained with conventional treatment. As external fixation is minimally-invasive, we expected a lower rate of morbidity and a reduced need for blood transfusions. We compared fixation with DHS vs. Orthofix pertrochanteric fixator (OPF) in elderly pertrochanteric fracture patients. Forty consecutive pertrochanteric fracture patients were randomized to receive either 135A1 4-hole DHS (Group A) or OPF with 4 HA-coated pins (Group B). Inclusion criteria were: female, age B3 65 years, AO type A1 or A2 and BMD less than −2.5 T score. There were no differences in patient age, fracture type, BMD, ASA, hospital stay or quality of reduction. Operative time was 64 B1 6 minutes in Group A and 34 B1 5 minutes in Group B (p < 0.005). Average number of post-operative blood transfusions was 2.0 B1 0.1 in Group A, and none in Group B (p < 0.0001). Pain was measured 5 days post-operatively and was lower in Group B (p < 0.005). Fracture varization at 6 months was 6 B1 8A1 in Group A and 2 B1 1A1 in Group B (p = 0.002). In Group B, no pin-tract infections occurred. Pin fixation improved over time, as shown by pin extraction torque (2770 B1 1710 N/mm) greater than insertion torque (1967 B1 1254 N/mm), (p= 0.001). Harris hip score at 2 years was 62 B1 20 in Group A and 63 B1 17 in Group B. This study shows that OPF with HA-coated pins is an effective treatment for this patient population. Operative time is brief, blood loss is minimal, fixation is adequate and the reduction is maintained over time.