Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included
In recent literature, the fragility index (FI) has been used to evaluate the robustness of statistically significant findings of dichotomous outcomes. This metric is defined as the minimum number of outcome events to flip study conclusions from significant to nonsignificant. Orthopaedics literature is frequently found to be fragile with a median FI of 2 in 150
The aim was to analyze the efficacy of zoledronic acid (ZA) versus denosumab in the prevention of pathological fractures in patients with bone metastases from advanced cancers by evaluating all available randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed and MEDLINE) was performed to identify all published
To determine in skeletally mature patients with a traumatic, first-time, patellar dislocation, the effect of early MPFL reconstruction versus rehabilitation on the rate of recurrent patellar dislocations and functional outcomes. Three online databases MEDLINE, EMBASE and PubMed were searched from database inception (1946, 1974, 1966 respectively), to August 20th, 2021, for literature addressing the management of patients sustaining acute first-time patellar dislocations. Data on redislocation rates, functional outcomes using the Kujala score, and complication rates were recorded. A meta-analysis was used to pool the mean postoperative kujala score as well as calculate the proportion of patients sustaining redislocation episodes using a random effects model. A risk of bias assessment was performed for all included studies using the MINORS and Detsky scores. Overall, there were a total of 22 studies and 1705 patients included in this review. The pooled mean redislocation rate in 18 studies comprising 1409 patients in the rehabilitation group was 31% (95% CI 25%-36%, I2 = 65%). Moreover, the pooled mean redislocation rate in five studies comprising 318 patients undergoing early MPFL reconstruction was 7% (95% CI 2%-17%, I2 = 70%). The pooled mean postoperative Kujala anterior knee pain score in three studies comprising 67 patients in the reconstructive group was 91 (95% CI 84-97, I2 = 86%), compared to a score of 81 (95% CI 78-85, I2 = 78%) in 7 studies comprising 332 patients in the rehabilitation group. The reoperation rate was 9.0% in 936 patients in the rehabilitation group and 2.2% in 322 patients in the reconstruction group. Management of acute first-time patellar dislocations with MPFL reconstruction resulted in a lower rate of redislocation and a higher Kujala score, as well as noninferiority with respect to complication rates compared to nonoperative treatment. The paucity of high-level evidence warrants further investigation in this topic in the form of well-designed and high-powered
The aim was to analyze whether non-steroidal anti-inflammatory drugs (NSAIDs) have an adverse effect on bone healing by evaluating all available human randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed, MEDLINE, and Cross-References) was performed to identify
Lung cancer is the most common cancer diagnosed, the leading cause of cancer-related deaths, and bone metastases occurs in 20–40% of lung cancer patients. They often present symptomatically with pain or skeletal related events (SREs), which are independently associated with decreased survival. Bone modifying agents (BMAs) such as Denosumab or bisphosphonates are routinely used, however no specific guidelines exist from the National Comprehensive Cancer Center or the European Society of Medical Oncologists. Perhaps preventing the formation of guidelines is the lack of a high-quality quantitative synthesis of randomized controlled trial (RCT) data to determine the optimal treatment for the patient important outcomes of 1) Overall survival (OS), 2) Time to SRE, 3) SRE incidence, and 4) Pain Resolution. The objective of this study was to perform the first systematic review and network meta-analysis (NMA) to assess the best BMA for treatment of metastatic lung cancer to bone. We conducted our study in accordance to the PRISMA protocol. We performed a librarian assisted search of MEDLINE, PubMed, EMBASE, and Cochrane Library and Chinese databases including CNKI and Wanfang Data. We included studies that are
Introduction. Treatment of non-union in open tibial fractures Gustilo-Anderson(GA)-3A/3B fractures remains a challenging problem. Most of these can be dealt using treatment methods that requires excision of the non-union followed by bone grafting, masquelet technique, or acute shortening. Circular fixators with closed distraction or bone transport also remains a useful option. However, sometimes due to patient specific factors these cannot be used. Recently antibiotic loaded bone substitutes have been increasingly used for repairing infected non-unions. They provide local antibiotic delivery, fill dead space, and act as a bone conductive implant, which is resorted at the end of a few months. We aimed to assess the outcome of percutaneous injection of bone substitute while treating non-union of complex open tibial fractures. Materials & Methods. Three cases of clinical and radiological stiff tibial non-union requiring further intervention were identified from our major trauma open fracture database. Two GA-3B cases, treated with a circular frame developed fracture-related-infection(FRI) manifesting as local cellulitis, loosened infected wires/pins with raised blood-markers, and one case of GA-3A treated with an intramedullary nail. At the time of removal of metalwork/frame, informed consent was obtained and Cerament-G. TM. (bone-substitute with gentamicin) was percutaneously injected through a small cortical window using a bone biopsy(Jamshedi needle). All patients were allowed to weight bear as tolerated in a well-fitting air-cast boot and using crutches. They were followed up at 6 weekly intervals with clinical assessment of their symptoms and radiographs. Fracture union was assessed using serial radiographs with healing defined as filling of fracture gap, bridging callus and clinical assessment including return to full painless weight bearing. Results. Follow-up at 6 months showed all fractures had healed with no defect or gaps with evidence of new trabecular bone and significant resorption of Cerament-G. TM. at final follow-up. There was no evidence of residual infection with restoration of normal limb function. Fractures with no internal fixation showed a mild deformity that had developed during the course of the healing, presumed due to mild collapse in the absence of fixation. These were less than 10 degrees in sagittal and coronal planes and were clinically felt to be insignificant by the patients. Conclusions. Cerament-G's unique combination of high dose antibiotics and hydroxy apatite matrix provided by calcium sulphate might help provide an osteoconductive environment to allow these stiff non-unions to heal. The matrix appears to provide a scaffold-like structure that allows new bone in-growth with local release of antibiotics helping reduce deep-seated infections. The final deformation at fracture site underlines the need for fixation- and it is very unlikely that this technique will work in mobile nonunions. Whilst similar fractures may heal without the use of bone substitute injections, the speed of healing in presence of significant fracture gap suggests the use of these bone substitutes did help in our cases. Further studies with a larger cohort, including
Background. Effectiveness of computer-assisted joint replacement (CA-TJR) compared to conventional TJR has been evaluated by a large body of literature. Systematic reviews provide a powerful, widely accepted, evidence-based approach to synthesize the evidence and derive conclusions, yet the strength of these conclusions is dependent on the quality of the review. Multiple systematic reviews compared CA-TJR and conventional TJR with conflicting results. We aimed to assess the quality of these reviews. Methods. We searched MEDLINE, EMBASE, the Cochrane, and Epistemonikos to identify SRs published through May 2017. Full-text articles that met inclusion criteria were retrieved and assessed independently by two reviewers. Evidence was qualitatively synthesized and summarized. Outcome measures were categorized into functional, radiological, and patient safety related. The corrected covered area (CCA) was calculated to assess the degree of overlap between SRs in analyzing the same primary studies. The AMSTAR 2, a valid and reliable tool, was applied to rate the confidence in the results of the SRs (Shea et al., 2017). AMSTAR-2 has 16 domains, of which 7 are critical (e.g., justification for excluding individual studies) and 9 are non-critical (e.g., not reporting conflict of interest for individual studies). Reviews are rated as high (no critical or non-critical flaws), moderate (only non-critical flaws), low (1 critical flaw) and critically low (more than one critical flaw). Disagreement between the 2 reviewers was resolved by discussion with the senior author to achieve consensus. We reported the quality ratings of these studies and the frequency of critical and non-critical flaws. Results. Of 384 citations originally identified, 37 systematic reviews were included. Meta-analyses that addressed TKA showed discrepancy on functional (e.g. KSS), radiological (mechanical axis malalignment), and patient safety (e.g. adverse events) outcomes. Meta-analyses that addressed THA showed more consistent results. Moderate overlap was observed among TKA SRs (CCA=7%) and very high overlap among THA SRs (CCA=26%). Based on the AMSTAR 2 tool, 35 studies were rated critically low and two studies were rated low. Low rating was due to failure in: developing a review protocol (94.6%); using a comprehensive search strategy (56.8%), providing a list of excluded studies (89%); accounting for risk of bias in the primary
A commonly misunderstood principle in medical literature is statistical significance. Often, statistically non-significant or negative results are thought to be evidence for equivalence; mistakenly validating treatment modalities and putting patients at risk. This study examines the prevalence of misinterpretation of negative results of superiority trials in orthopaedic literature and outlines the need for a non-inferiority or equivalence research design. Four orthopaedic journals – Journal of Paediatric Orthopaedics A, Journal of Bone and Joint Surgery American Volume, Journal of Arthroplasty and Journal of Shoulder and Elbow Surgery – were hand searched to identify all randomised control trials (RCTs) published within the time periods 2002–2003, 2007–2008 and 2012–2013. The identified
Background. To conduct a systematic review and network meta-analysis of
Persistent post-surgical pain affects 10%-80% of individuals after common operations, and is more common among patients with psychological factors such as depression, anxiety, or catastrophising. We conducted a systematic review and meta-analysis of randomised, controlled trials to evaluate the efficacy of perioperative psychotherapy for persistent postsurgical pain and physical impairment. We searched Medline, PsycINFO, CINAHL, and the Cochrane Central Registry of Controlled Trials to identify relevant
Ten
Purpose. Infections in orthopaedic surgery are costly, debilitating complications. The search for new treatments and prevention strategies has led to the use of antibiotic-filled calcium sulfate (CaS) as a bone void filler that is both safe and effective. The purpose of this study was to examine the available data on the efficacy of this technology. Methods. A literature search was performed for studies that evaluated the use of antibiotic-loaded CaS cement in orthopaedics published between inception of the databases to 2017. Selected studies included randomized controlled trials (RCTs) and observational studies published in the English language that met the following criteria: 1) patients underwent an orthopaedic procedure; 2) CaS cement with an antibiotic was used; and 3) at least one of our outcomes were mentioned. Outcomes included resolution of infection, complications related to treatment, subsequent surgeries, overall infection rate, fracture union rate, clinical outcomes, and wound complications. A total of 17 studies were included. Results. Ten studies examined the use of antibiotic-eluting CaS cement with surgical debridement to treat osteomyelitis and reported resolution rates ranging from 80–100%. Two studies examined CaS for prophylaxis of infection after open fracture, with subsequent infection rates ranging from 0–22%. Two studies examined infected non-unions with CaS used as an adjunct to surgery with an 87.5% infection clearance rate. Finally, three studies examined the use of local antibiotic release from CaS in the repair of infected TKAs or THAs, with success rates ranging from 52–93.3%. Conclusion. Initial results support the use of CaS with surgical debridement for osteomyelitis and infected non-unions. Results are mixed for CaS use in the prophylaxis of infection after open fractures and for PJIs, thereby necessitating further research. Overall the studies were small, retrospective, and lacked controls. Further research should focus on
Three-dimensional (3D) printing has become more frequently used in surgical specialties in recent years. Orthopaedic surgery is particularly well-suited to 3D printing applications, and thus has seen a variety of uses for this technology. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production. As with any new technology, it is important to assess the clinical impact, if any, of three-dimensional printing. The purpose of this review was to answer the following questions:
. What are the current clinical uses of 3D printing in orthopaedic surgery?. Does the use of 3D printing have an effect on peri-operative outcomes?. Four electronic databases (Embase, MEDLINE, PubMed, Web of Science) were searched for Articles discussing clinical applications of 3D printing in orthopaedics up to November 13, 2018. Titles, abstracts, and full texts were screened in duplicate and data was abstracted. Descriptive analysis was performed for all studies. A meta-analysis was performed among eligible studies to compare estimated blood loss (EBL), operative time, and fluoroscopy use between 3D printing cases and controls. Study quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) criteria for non-randomized studies and the Cochrane Risk of Bias Tool for randomized controlled trials (RCTs). This review was prospectively registered on PROSPERO (Registration ID: CRD42018099144). One-hundred and eight studies were included, published between 2012 and 2018. A total of 2328 patients were included in these studies, and 1558 patients were treated using 3D printing technology. The mean age of patients, where reported, was 47 years old (range 3 to 90). Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3D printing (N = 63), followed by final implants (N = 32) and PSI (N = 22). Titanium was the most commonly used 3D printing material (16 studies, 27.1%). A wide range of costs were reported for 3D printing applications, ranging from “less than $10” to $20,000. The mean MINORS score for non-randomized studies was 8.3/16 for non-comparative studies (N = 78), and 17.7/24 for non-randomized comparative studies (N = 19). Among
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
Acute metatarsal fractures are a common extremity injury. While surgery may be recommended to reduce the risk of nonunion or symptomatic malunion, most fractures are treated with nonoperative management. However, there is significant variability between practitioners with no consensus among clinicians on the most effective nonoperative protocol, despite how common the form of treatment. This systematic review identified published conservative treatment modalities for acute metatarsal fractures and compares their non-union rate, chronic pain, and length of recovery, with the objective of identifying a best-practices algorithm. Searches of CINAHL, EMBASE, MEDLINE, and CENTRAL identified clinical studies, level IV or greater in LOE, addressing non-operative management strategies for metatarsal fractures. Two reviewers independently screened the titles, abstracts, and full texts, extracting data from eligible studies. Reported outcome measures and complications were descriptively analyzed. Studies were excluded if a rehabilitation program outlining length of immobilization, weight-bearing and/or strengthening approaches was not reported. A total of 12 studies (8
Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.Aims
Methods
Bearing surfaces in Total Hip Arthroplasty (THA) may affect implant longevity and hence patient outcomes. This randomised clinical trial (RCT) determined how ceramic-on-ceramic bearing (CERAMIC) THA affected joint-specific pain, function and stiffness, and prosthesis fixation/longevity over 10 postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing (POLYETHYLENE) THA. This is a follow-up to previously reported five year outcomes. Subjects aged less than 61 years were randomised to CERAMIC [n=48] or POLYETHYLENE [n=44] THA. Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and the RAND 12-Item Health Survey (RAND-12) preoperatively, and at one, five and 10 years postoperatively. Plain radiographs were evaluated at 10 years for fixation and medical records were reviewed for revisions. Of 92 subjects, six (7%) died within 10 years; 68 (79%) survivors provided radiographic and/or clinical follow-up at 10 years postoperatively. Improvements seen at five years in both the WOMAC and RAND-12 were retained at 10 years with no group differences (p>0.48). There were no failures/loss of fixation related to bearing surfaces/wear in either group. Over 10 years, three subjects in the POLYETHYLENE group had revisions that were related to recurrent dislocation; two revisions were performed within two years of surgery and one further subject underwent revision at 7 years postoperatively. This is one of the first
Wear of the tibial polyethylene liner of total knee arthroplasty (TKA) is complex and multifactorial. The issues involved include those of implant design and locking mechanism, surgical-technical variability, and patient weight and activity level. However, tibial polyethylene fabrication, including bar stock, amount of irradiation, quenching of free radicals, and sterilization may also be factors in the long-term survival of TKA. Highly crosslinked polyethylene is now widely used in total hip arthroplasty, but its value and use in TKA is a subject of great controversy. In making a decision to use these products, the surgeon should consider multiple sources of evidence: in-vitro wear testing; clinical cohort studies; randomised controlled trials; registry survival data; and retrieval analyses. The two questions to be asked are: is there a value or benefit in the use of these new polyethylenes, and what are the risks involved with the use of these products?. Laboratory testing, generally to 5 million cycles, has shown a significant decrease in tibial polyethylene wear of several products, with both cruciate-retaining and substituting designs, and under adverse conditions. Retrospective cohort studies and
Orthopaedic infection is a potentially serious complication of elective and emergency trauma and orthopaedic procedures, with a high associated burden of morbidity and cost. Optimization of vitamin D levels has been postulated to be beneficial in the prevention of orthopaedic infection. This study explores the role of vitamin D in orthopaedic infection through a systematic review of available evidence. A comprehensive search was conducted on databases including Medline and Embase, as well as grey literature such as Google Scholar and The World Health Organization Database. Pooled analysis with weighted means was undertaken.Aims
Methods