The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169–74

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161–8

Aim. This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing. Method. A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained. Results. A total of 242 patients completed the required follow-up (ciNPT: n = 124 (84.4%); SOC: n = 118 (80.3%)). Demographics, baseline comorbidities, causes of revision (prosthetic joint infection, aseptic loosening, implant-related, and periprosthetic fractures), and duration of treatment were similar in both cohorts (p > 0.05). Intention to treat analysis demonstrated lower rates of SSC with ciNPT (3.4%) compared to SOC (14.3%) (p = 0.0013) (Table 1 – not included in the proceeding). Similar outcomes were obtained with the modified intention to treat analysis (p = 0.0013). The ciNPT cohort exhibited lower readmission rates (p = 0.0208), and number of dressing changes (p = 0.0003). Conversely, differences in the 90-day incidence of SSI and measured patient-reported outcomes did not reach statistical significance (p > 0.05). Conclusions. ciNPT mitigates the risk of SSC and readmission among high-risk rTKA patients. The lower frequency of dressing changes within the ciNPT cohort may provide added value for healthcare utilization without compromising pain and function. For the table, please contact authors directly

Acute Compartment Syndrome (ACS) is an orthopaedic emergency that can develop after a wide array of etiologies. In this pilot study the MY01 device was used to assess its ease of use and its ability to continuously reflect the intracompartmental pressure (ICP) and transmit this data to a mobile device in real time. This preliminary data is from the lead site which is presently expanding data collection to five other sites as part of a multi-center study.

Patients with long bone trauma of the lower or upper extremity posing a possibility of developing compartment syndrome were enrolled in the study. Informed consent was obtained from the patients. A Health Canada licensed continuous compartmental pressure monitor (MY01) was used to measure ICP. The device was inserted in the compartment that was deemed most likely to develop ACS and ICP was continuously measured for up to 18 hours. Fractures were classified according to the AO/OTA classification. Patient clinical signs and pain levels were recorded by healthcare staff during routine in-patient monitoring and were compared to the ICP from the device. Important treatment information was pulled from the patient's chart to help correlate all of the patient's data and symptoms.

The study period was conducted from November 2020 through December 2021. Twenty-six patients were enrolled. There were 17 males, and nine females. The mean age was 38 years (range, 17–76). Seventeen patients received the device post-operatively and nine received it pre-operatively. Preliminary results show that post-operative ICPs tend to be significantly higher than pre-operative ICPs but tend to trend downwards very quickly. The trend in this measurement appears to be more significant than absolute numbers which is a real change from the previous literature. One patient pre-operatively illustrated a steep trend upwards with minimal clinical symptoms but required compartment release at the time of surgery that exhibited no muscle necrosis. The trend in this patient was very steep and, as predicted, predated the clinical findings of compartment syndrome. This trend allows an early warning signal of the absolute pressure, to come, in the compartment that is being assessed by the device.

Preliminary results suggest that this device is reliable and relatively easy to use within our institutions. In addition it suggests that intracompartmental pressures can be higher immediately post-op but lower rapidly when the patient does not develop ACS. These results are in line with current literature of the difference between pre and post-operative baselines and thresholds of ICP, but are much more striking, as continuous measurements have not been part of the data set in most of past studies.

Further elucidation of the pressure thresholds and profiles are currently being studied in the ongoing larger multicenter study and will add to our understanding of the critical values. This data, plus the added value of continuous trends in the pressure, upwards or downwards, will aid in preventing muscle necrosis during our management of these difficult long bone fractures.

Abstract

Introduction

Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA).

Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

To compare 24-month patient-reported outcomes after surgical treatment or casting in patients age 60 years of age or older with unstable distal radius fractures (DRF's).

The Wrist and Radius Injury Surgical Trial (WRIST), is the largest randomized, multicenter trial in Hand Surgery, which enrolled 304 adults with isolated, unstable DRF's at 24 institutions. WRIST participants were followed for 24 months- longest follow-up among prospective studies comparing four treatment methods. Patients who agreed to surgical treatment (n=187) were randomized to internal fixation with volar plate (VLPS), external fixation, or percutaneous pinning; patients who preferred conservative management (n=117) received casting. The primary outcome was 24-month Michigan Hand Outcomes Questionnaire (MHQ) Summary score. Secondary outcomes were MHQ Domain scores.

At 24-month assessment, participants' mean MHQ Summary score was 86 (95% CI: 83,88), representing good hand function. Participants reported good return of their Activities of Daily Living (ADLs) with a mean MHQ ADL score of 88 (95% CI: 85,91). Finally, participants were satisfied, with a mean MHQ Satisfaction score of 84 (95% CI: 80,88). There were no significant differences in score by treatment group in any MHQ domain at 24 months. Six weeks after surgery, VLPS participants scored significantly higher than the other three groups on (ADLs) and Satisfaction (both p<0.0001), whereas participants who received external fixation scored significantly lower than the casting and VLPS groups on the same domains. By the 3-month assessment, the gap between VLPS and casting had disappeared but external fixation participants continued to report significantly worse scores. External fixation participants did not report comparable ADL scores to the other three groups until 12 months after surgery.

Participants reported good outcomes 24 months after DRF regardless of treatment. Casting and VLPS are both acceptable treatments for older adults. The decision between the two treatments should be made considering patient goals regarding recovery speed and desire to avoid surgical risks. External fixation should be avoided because of worse outcomes in the year after surgery and the risk of pin site infections.

The purpose of this study was to quantify tibial tunnel enlargement at 3-, 6- and 12-months post-anterior cruciate ligament reconstruction (ACLR), and evaluate the magnitude of tunnel widening with use of a Poly (L-lactic Acid) interference screw (PLLA (Bioscrew XtraLok, Conmed, New York)) compared to a Poly (L-lactic Acid) + tricalcium phosphate interference screw (PLLA+TCP (GENESYS Matryx screw comprised of microTCP and 96L/4D PLA, Conmed, New York)).

This was a prospective randomized controlled trial with two parallel groups. Eighty unilateral ACL-deficient participants awaiting ACLR surgery were recruited between 2013 and 2017 from the clinic of a sole fellowship trained orthopaedic surgeon. Patients had to be skeletally mature and less than 45 years old, with no concomitant knee ligament injuries requiring surgery, chondromalacia, or previous history of ipsilateral knee joint pathology, surgery or trauma to the knee.

Participants were randomized intra-operatively into either the PLLA or PLLA+TCP tibial interference screw fixation group. Study time points were pre-, 3-, 6-, and 12-months post ACLR. Participants underwent x-rays with a 25 mm calibration ball, IKDC knee assessment, and completed the ACL-Quality of Life score (ACL-QOL) at each visit.

Measurement (mm) of the most proximal and distal extents as well as the widest point of the tibial tunnel were taken using efilm (IBM Watson Health) and were standardized relative to the calibration ball. A contrast inverter was used to determine clear borders based on contrast between normal and drilled bone. In addition, a subjective evaluation of the tunnel was conducted looking for bowing of the borders of the tunnel or change in tunnel shape, categorizing the tunnel as widened or not widened.

Differences between groups at each time point were evaluated using independent t-tests corrected for multiple comparisons. Tunnel width was also compared as a percentage of actual screw size at 12-months post-operative. Categorical data were compared using Fisher's Exact Test. Forty participants were randomized to each group with mean age (SD) of 29.7 (7.6) and 29.8 (9.1), for PLLA and PLLA+TCP, respectively. There were no differences between groups in age, gender or ACL-QOL.

There were no differences found between groups at any time point in either tunnel width measurements or tunnel width as a percentage of actual screw size. The greatest difference between groups was noted in the measurement of the widest point on lateral x-ray view with a mean difference of 11%. Based on subjective evaluation of tunnel shape, three participants had visible widening in the PLLA group, and two in the PLLA+TCP group (p=NS).

No differences in tunnel widening were identified between ACL reconstruction patients using a PLLA interference screw compared to a PLLA+TCP screw for tibial fixation up to 12-months post-operative.

The aim was to identify the acetabular center, fix the acetabular implant, and reconstruct the hip rotation center using the residual Harris fossa and acetabular notch as anatomical markers during revision hip arthroplasty. Osteolysis is commonly found in the acetabulum during hip arthroplasty revision. It causes extensive defects and malformation of the anatomical structure, making correct fixation of a hip prosthesis difficult. We studied the relations of the anatomical positions between the Harris fossa and acetabular notch and the acetabular center (Fig. 1). Vertical distance from the hip rotation center to the teardrop connection and horizontal distance from the hip rotation center to the teardrop were measured on preoperative and postoperative radiographs. Vertical distance increased from 14.22±3.39 mm preoperatively to 32.64±4.51 mm postoperatively (t=3.65, P<0.05) and the horizontal distance from 25.13±3.46 mm to 32.87±4.73 mm (t=2.72, P<0.05). Altogether, 28 patients underwent revision hip arthroplasty based on the Paprosky classification for bone loss. The anatomical hip center was identified using the residual Harris fossa and acetabular notch as anatomical markers during revision hip arthroplasty. Based on these relations, we were able to place the hip prosthesis correctly. After surgery, restoration of the anatomical hip center was accomplished based on data obtained from radiographs(Fig.2 and Fig.3).

Introduction

Total Knee Arthroplasty (TKA) is highly successful in treatment of end-stage degenerative arthritis of the knee. CT-based Patient-Specific Instrumentation (PSI) utilizes a CT scan of the lower extremity to create a three-dimensional model of the patient's anatomy, plan the surgery, and provide unique patient-specific resection blocks for the surgery.

There are few published studies utilizing CT-PSI. The present study prospectively evaluates clinical, operative, and radiographic outcomes from 100 CT-based TKAs using this technology (MyKnee®, Medacta International S.A., Castel San Pietro, Switzerland).

The MediShoe (Promedics Orthopaedics Ltd, Glasgow) is a specific post-operative foot orthosis used by post-operative foot and ankle patients designed to protect fixations, wounds and maximise comfort. The use of rigid-soled shoes has been said to alter joint loading within the knee and with the popular use of the MediShoe at our centre in post operative foot and ankle surgery patients, it is important to ascertain whether this is also true.

An analysis of the knee gait kinetics in healthy subjects wearing the MediShoe was carried out. Ten healthy subjects were investigated in a gait lab both during normal gait (control) and then with one shoe orthosis worn. Force plates and an optoelectronic motion capture system with retroreflective markers were used and placed on the subjects using a standardised referencing system. Three knee gait kinetic parameters were measured:- knee adduction moment; angle of action of the ground reaction force with respect to the ground in the coronal plane as well as the tibiofemoral angle. These were calculated with the Qualisys software package (Gothenburg, Sweden).

A two-tailed paired t-test (95% CI) showed no significant difference between the control group and the shoe orthosis-fitted group for the knee adduction moment (p = 0.238) and insignificant changes with respect to the tibiofemoral angle (p = 0.4952) and the acting angle of the ground reaction force (p = 0.059).

The MediShoe doesn't significantly alter knee gait kinetics in healthy patients. Further work, however is recommended before justifying its routine use.

Introduction

Cross-linked polyethylene in total hip arthroplasty has demonstrated excellent long-term wear resistance, leading to its acceptance as the standard bearing used in hip replacement. Adoption in knee replacement has been tentative, as the cross-linking process can decrease the polyethylene mechanical properties. The current study's purpose was examining survivorship of a fixed bearing knee replacement system featuring a moderately cross-linked polyethylene (MXLK) bearing, a cobalt chrome (CoCr) tibial tray with a highly polished top surface, and a new polyethylene-to-tray locking mechanism. The MXLK is made of ultra-high molecular weight GUR1020 resin irradiated with 5 Mrad gamma radiation, followed by a free radical quenching remelting annealing process, above the 135 degree melting point, that provides wear and fatigue resistance, and oxidative stability.

Background

The reductions of perioperative blood loss and inflammatory response are important in total knee arthroplasty. Tranexamic acid reduced blood loss and the inflammatory response in several studies. However, the effect of epinephrine administration plus tranexamic acid has not been intensively investigated, to our knowledge. In this study, we evaluated whether the combined administration of low-dose epinephrine plus tranexamic acid reduced perioperative blood loss or inflammatory response further compared with tranexamic acid alone.

Purpose. Femoral nerve block (FNB) following total knee arthroplasty (TKA) has had mixed results with some studies reporting improvement in pain and reduced narcotic exposure while others have not shown substantial differences. The effect of a FNB on rehabilitation indices (quadriceps strength, knee flexion) is also unclear. The study purpose was to compare the effect of FNB+ a multimodal analgesic protocol (MMA) to MMA only on the 1) development of a complete quadriceps motor block and 2) knee flexion during the first two postoperative days and 3) knee flexion out to 12 weeks after primary TKA. Secondarily, we compared hospital length of stay (LOS), postoperative pain, analgesic use and the incidence of nausea/vomiting. Method. This was a controlled clinical trial undertaken at two tertiary hospitals that do high annual TJA volumes (>200 cases). Both hospitals followed the same regional clinical pathway for preoperative, perioperative and postoperative care. The pathway started mobilization on the day of surgery with a goal for discharge home on the third postoperative day. At one site, FNB was used for the first two postoperative days in addition to MMA as needed (FNB group [n=19]) while the other site used standardized MMA (MMA group [n=20]) only. The presence of a complete quadriceps block, knee flexion, pain, analgesic use, incidence of nausea and vomiting were recorded daily in hospital. Hospital LOS was also recorded and knee flexion and pain were assessed at two, six and 12 weeks post discharge. Results. The groups were similar preoperatively in terms of age (p=0.27), gender (p=0.34), preoperative function (p=0.63) and knee flexion (p=0.83). In the FNB group, 10 (52%) had a complete quadriceps motor block on the day of surgery and 13 (68%) on the first postoperative day compared with no complete motor blocks in the MMA group (p<0.001). Pain and analgesic use was similar between groups (p>0.21) as was the incidence of nausea/vomiting (p>0.66). Knee flexion was similar at discharge(p=0.87) and at all post-discharge visits (p>0.14). Median LOS was 4(Interquartile range [IQR] 4,5) days and 3.5(3,4) days in the FNB and MMA groups respectively (p=0.04). Conclusion. The addition of a FNB to a MMA regimen did not confer advantages in pain control, analgesic use, nausea/vomiting or knee flexion. FNB significantly increased the likelihood of a complete quadriceps motor block in the initial postoperative period. Hospital LOS was also increased in the FNB group. These results are inconsistent with previous reports of FNB benefits, but may reflect the heterogeneous nature of clinical practice among centres, evolution of pain management into MMA techniques (+/− FNB) and the trend to shorter LOS and more aggressive postoperative rehabilitation. Further, multiple practitioners with varying experience performed the FNB. A randomized trial is needed to compare current MMA protocols to controlled FNB technique when an accelerated postoperative rehabilitation program is utilized

Purpose

Implant positioning is one of the critical factors influencing the postoperative outcome in total hip arthroplasty (THA). Conventional (manual) intraoperative stem adjustment may result in variability and inaccuracy of stem antetorsion (AT). Since March 2013, we have measured stem antetorsion with CT free Navigation system (OrthoPilot Navigation System THA Pro Ver4.2, B/Braun Aesculap Germany: Navi). We have developed a simple instrument, the Gravity-guide (G-guide), for intraoperative assessment and adjustment of stem AT. We evaluated the accuracy and effectiveness of G-guide and navigation software as referenced to postoperative CT evaluation with 3D template system (Zed hip, LEXI, Japan).

Shear plane non unions: biomechanical study and clinical application using an all wire Illizarov frame.

60 degree osteotomy of plastic tibiae were stabilised using four different Ilizarov frame configurations.

Models were loaded and shear displacement measured at the fracture site. The optimum frame design was identified and used in clinical practice.

The transfracture locked olive wire frame model offered the least displacement in the experimental model This frame model was used in two patients with shear plane non unions and both healed satisfactorily Both displacements had previously failed to unite with standard frame constructs.

Transfracture locked olive wire frame design is useful in the treatment of tibial non unions with shear plane.

Background:

Modified posterior approach and its effect on stability and functional outcome in total hip arthroplasty.

The aim of tissue sparing surgery in total knee arthroplasty is to reduce surgical invasivity to the entire knee joint. Surgical invasion should not be limited only toward soft tissues but also toward bone. The classic technique for total knee arthroplasty implies intramedullary canal invasion for proper femoral component positioning. This phase is associated to fat embolism, activation of coagulation, and occult bleeding from the reamed canal. The purpose of our study was to validate a new extramedullary device which relies on templated data.

Two-hundred patients in four different orthopaedics centres were randomized to undergo primary total knee arthroplasty either using standard intramedullary femoral instruments (IM group) or using a new extramedullary device (EM group). A new set of instruments was developed to control the sagittal and coranl plane of the distal femoral resection. The extramedullary instrument was calibrated referencing to templated data obtained from the preoperative long-limb radiograph (Fig 1, 2). Varus-valgus orientation of the resection were established by moving the two paddles according to templated data. An L-shaped sliding tool (5 centimetres long) over the anterior cortex controls the flexion-extension parameter of the resection and is intended to allow a cut flush with the anterior cortex at 0° of angulation with the distal aspect of the femoral diaphysis on the sagittal plane

Femoral component coronal alignment was within 0±3° of the mechanical axis in 86% of the IM group and 88% of the EM group. Sagittal alignment of the femoral component was 0±3° in 80% of the IM group and 94% of the EM group. There was no difference in the average operative time between the two groups. The EM group showed a trend toward less postoperative blood loss

Extramedullary reference with careful preoperative templating can be safely utilized during total knee arthroplasty.

Objective

The optimal dosage and timing of tranexamic acid in total hip arthroplasty (THA) still is undetermined. Previous studies showed the hyper-fibrinolysis would last for 18 hours after surgery. The study aimed to examine the efficacy and safety of multiple bolus of intravenous TXA on hidden blood loss and inflammation response following primary THA.