Explanatory and pragmatic trials in orthopaedics - Have we done the right studies?

Recent decades have seen marked advances in the quality of clinical orthopaedic trauma research, and with this has come a rise in the number of randomised clinical trials (RCTs) being conducted in orthopaedic trauma. These trials have been largely valuable in driving evidence-based management of injuries which previously had clinical equipoise. However, though RCTs are traditionally seen as the 'gold standard' of high-quality research, this research method is comprised primarily of two entities, explanatory and pragmatic designs, each with its own strengths and limitations. Most orthopaedic trials lie within a continuum between these designs, with varying degrees of both pragmatic and explanatory features. In this narrative review we provide a summary of the nuances within orthopaedic trial design, the advantages and limitations of such designs, and suggest tools which may aid clinicians in the appropriate selection and evaluation of trial designs.

Fracture nonunion in long bones: A literature review of risk factors and surgical management.

Nonunion following a long bone fracture causes considerable morbidity when it occurs. Risk factors depend on specific fractures but there is a complex interplay of injury severity, comorbidities, patient medication and infection. The majority of nonunions occur after long bone fractures with the tibia, femur, forearm, humerus and clavicle predominating. Despite interest in the biological augmentation of fracture healing, the majority of nonunions can be effectively managed with conventional surgical techniques. In this review we present a review of risk factors for nonunion and the outcome following surgical management.

Closure of the appendiceal stump in laparoscopic appendectomy: A systematic review of the literature.

BACKGROUND: Closure of the appendiceal stump is a key step performed during laparoscopic appendicectomy. Inadequate management of the appendiceal stump has the potential to cause significant morbidity. Several methods of stump closure have been described, however high-level evidence is limited. We performed a systematic review evaluating clinical outcomes and quality of the evidence for the methods of appendiceal stump closure. METHODS: A systematic literature search was performed using Medline, Embase, Cochrane Database and Google Scholar to identify studies comparing appendiceal stump closure methods in laparoscopic appendectomy for acute appendicitis from inception to October 2019. Data regarding operative duration, peri-operative complications, length of stay and costs were collated from all included studies. RESULTS: From 160 identified studies, 19 met the inclusion criteria. Endoloops and endoclips provide equivalent clinical outcomes at lower cost, while operative duration was shortest with endoclip closure. Endostapler devices have the lowest rate of peri-operative complications (3.56%), however their cost limits their regular use in many healthcare environments. Post-operative complication rate and length of stay were similar for all stump closure methods. Conclusion: Although there are no significant differences in method of stump closure in laparoscopic appendectomy, closure with endoclips provides the shortest operative duration. There is a need for robust and standardized reporting of cost data when comparing stump closure methods, together with higher level evidence in the form of multi-centre randomized controlled trials before firm conclusions can be drawn regarding the optimal method of stump closure.

Survival of the low contact stress rotating platform total knee replacement is influenced by age: 1058 implants with a minimum follow-up of 10 years.

BACKGROUND: The low contact stress (LCS) mobile-bearing total knee replacement (TKR) was designed to minimise polyethylene wear, aseptic loosening and osteolysis. However, registry data suggests there is a significantly greater revision rate associated. The primary aim of this study was to assess long-term survivorship of the LCS TKR performed at a single high-volume centre. Secondary aims were to assess survival by mechanism of failure and identify predictors of revision. METHODS: During a 13-year period (1993-2006) 1091 LCS TKRs were performed by two senior surgeons. Thirty-three with incomplete data were excluded. The patients were retrospectively identified from an arthroplasty register. Mean age was 69 (range 30-96) years. Five hundred seventy-seven TKRs were performed in females, 481 in males. Mean follow-up was 14 years (SD 4.3). RESULTS: There were 59 revisions during the study period: 14 (23.7%) for infection, 18 (30.5%) for instability, and 27 (45.8%) for polyethylene wear. Three hundred ninety-two patients died. All-cause survival at 10 years was 95% (95%CI 91.7-98.3) and at 15 years was 93% (95%CI 88.6-97.8). Survival at 10 years according to mechanism of failure was: infection 99% (95%CI 94-100%), instability 98% (95%CI 94-100%), and polyethylene wear 98% (95%CI 92-100). Of the 27 with polyethylene wear, only 19 (70.4%) had osteolysis requiring component revision, the other eight (29.6%) had polyethylene exchanges. Cox regression analysis identified younger age as the only predictor of revision (HR 0.96, 95%CI 0.94-0.99, p = 0.003), with a four percent decreased risk of revision for each increase in year of age. CONCLUSIONS: The LCS TKR demonstrates excellent long-term survivorship with a low rate of revision for osteolysis, however this risk is increased in younger patients.

Polymeric clips are a quicker and cheaper alternative to endoscopic ligatures for securing the appendiceal stump during laparoscopic appendicectomy.

Introduction The use of polymeric clips in securing the appendiceal stump has been increasingly reported as a viable alternative to current methods in emergency laparoscopic appendicectomy. We evaluated the operative outcomes following the use of polymeric clips versus endoscopic ligatures. The primary endpoint was operative time, with secondary outcomes including complications, inpatient stay, and cost analysis. Materials and methods Operative records were retrospectively analysed to identify patients undergoing laparoscopic appendicectomy between January 2014 and June 2015. Data collected included age, gender, body mass index, duration of surgery, length of hospital stay, antibiotic use, preoperative haematological and biochemical parameters, 30-day readmission rate and complications. Results A total of 125 patients were included within the study, with 78 within the endoloop group and 47 in the polymeric clip group. There were no differences in age, gender, body mass index, hospital stay, antibiotic use, 30-day readmission rates or postoperative complications. Operative time was significantly reduced in the polymeric clip group (59 vs. 68 minutes, P = 0.00751). The use of polymeric clips cost £21 compared with £49 for endoloops per operation, which rose to £70 if both clips and endoloops were used during the procedure. Discussion Polymeric clips are a safe, viable and economical method for securing the appendiceal stump during laparoscopic appendicectomy. The clinical significance of nine minutes of reduced operating time in the polymeric clip cohort warrants further study with an adequately powered randomised controlled trial.

Outcomes of Ulnar Shortening for Ulnar Impaction Syndrome Using the 2.7 mm AO Ulna Shortening Osteotomy System.

BACKGROUND: Ulnar shortening osteotomy is a well-established treatment for ulnar impaction syndrome. Controversy remains regarding the most effective system to achieve efficient bony union, whilst minimising incidence of complications, particularly hardware irritation. We present outcomes at 2 years using the recently released low profile AO osteotomy system. METHODS: 32 consecutive patients with significant pain from ulnar impaction syndrome (idiopathic or post-traumatic), without degenerative changes of the distal radio-ulnar joint, were included. Time to union, range of motion, grip strength, pain and complications were recorded. RESULTS: Median time to union was 10.14 weeks (9.27-11.01, 95%CI), with one nonunion. Visual Analogue Pain score, grip strength and range of motion improved significantly. No patient experienced hardware irritation. No plate required removal. Positive ulnar variance was reduced by 3.8 mm (mean). CONCLUSIONS: The low profile AO system appears effective in achieving bony union whilst minimising incidence of hardware irritation, at a follow up of 2 years.

Columbus® computer navigated total knee arthroplasty: Gap balancing versus measured resection.

BACKGROUND: The aim of this study was to compare the medium term functional outcome and patient satisfaction of gap balanced (GB) with measured resection (MR) total knee arthroplasty (TKA) using computer navigation. METHODS: A cohort of 144 consecutive computer navigated TKA were retrospectively identified from an arthroplasty database. Functional assessment using the Oxford Knee Score (OKS) and patient satisfaction were obtained from 113 patients at a mean follow-up of 5.4 (range four to seven) years. There were 44 patients in the GB group and 69 patients in the MR group. RESULTS: The mean OKS for the GB group was 36.9 (SD 9.2) and for the MR was 33.6 (SD 9.8), with a difference of 3.3 (95% CI 0.3 to 6.3) points, which was statistically significant (p=0.01). Linear regression analysis confirmed the independent effect of surgical technique when adjusting for confounding factors and surgeon, with the GB group achieving a greater post-operative OKS (R2=0.39, 3.0 points, 95% CI 1.2 to 4.8, p=0.001). There was a greater rate of patient satisfaction in the GB group (88.6%, n=39/44) compared to the MR group (81.1%, n=56/69), but this was not statistically significant (odds ratio 1.8, 95% CI 0.6 to 5.5, p=0.31). CONCLUSION: Computer navigated Columbus® TKA using a GB technique results in a statistically significantly greater functional outcome but no significant difference in patient satisfaction in the medium term compared to patients undergoing a MR technique.

Large retropharyngeal abscess: a case of mistaken identity.

We report an unusual case of nasopharyngeal carcinoma (NPC), presenting initially as a retropharyngeal collection. We discuss the investigation, diagnosis and management of NPC and furthermore review the literature of NPC, emphasising the varied presentation. A 44-year-old Caucasian male ex-smoker presented with a 10-day history of a painless left-sided neck lump; progressive dysphagia and unintentional weight loss. Examination demonstrated a large left posterior pharyngeal swelling with soft palatal effacement, confirmed on nasoendoscopy. A CT scan revealed a fluid collection in the retropharyngeal space, which partially occluded the nasopharynx, and numerous satellite lesions were identified along with cervical lymphadenopathy. The suspected abscess was drained in theatre and nasopharyngeal biopsies were taken. These revealed Epstein-Barr virus-positive NPC. Staging investigations revealed a T4N2M0l carcinoma. Treatment consisted of radical chemoradiation therapy with curative intent. NPC is known for its varied and late presentation, and is an important condition to be aware of when considering a differential diagnosis of pharyngeal masses.