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Bone & Joint Open
Vol. 4, Issue 9 | Pages 704 - 712
14 Sep 2023
Mercier MR Koucheki R Lex JR Khoshbin A Park SS Daniels TR Halai MM

Aims. This study aimed to investigate the risk of postoperative complications in COVID-19-positive patients undergoing common orthopaedic procedures. Methods. Using the National Surgical Quality Improvement Programme (NSQIP) database, patients who underwent common orthopaedic surgery procedures from 1 January to 31 December 2021 were extracted. Patient preoperative COVID-19 status, demographics, comorbidities, type of surgery, and postoperative complications were analyzed. Propensity score matching was conducted between COVID-19-positive and -negative patients. Multivariable regression was then performed to identify both patient and provider risk factors independently associated with the occurrence of 30-day postoperative adverse events. Results. Of 194,121 included patients, 740 (0.38%) were identified to be COVID-19-positive. Comparison of comorbidities demonstrated that COVID-19-positive patients had higher rates of diabetes, heart failure, and pulmonary disease. After propensity matching and controlling for all preoperative variables, multivariable analysis found that COVID-19-positive patients were at increased risk of several postoperative complications, including: any adverse event, major adverse event, minor adverse event, death, venous thromboembolism, and pneumonia. COVID-19-positive patients undergoing hip/knee arthroplasty and trauma surgery were at increased risk of 30-day adverse events. Conclusion. COVID-19-positive patients undergoing orthopaedic surgery had increased odds of many 30-day postoperative complications, with hip/knee arthroplasty and trauma surgery being the most high-risk procedures. These data reinforce prior literature demonstrating increased risk of venous thromboembolic events in the acute postoperative period. Clinicians caring for patients undergoing orthopaedic procedures should be mindful of these increased risks, and attempt to improve patient care during the ongoing global pandemic. Cite this article: Bone Jt Open 2023;4(9):704–712


The Bone & Joint Journal
Vol. 102-B, Issue 4 | Pages 485 - 494
1 Apr 2020
Gu A Malahias M Selemon NA Wei C Gerhard EF Cohen JS Fassihi SC Stake S Bernstein SL Chen AZ Sculco TP Cross MB Liu J Ast MP Sculco PK

Aims. The aim of this study was to determine the impact of the severity of anaemia on postoperative complications following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Methods. A retrospective cohort study was conducted using the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database. All patients who underwent primary TKA or THA between January 2012 and December 2017 were identified and stratified based upon hematocrit level. In this analysis, we defined anaemia as packed cell volume (Hct) < 36% for women and < 39% for men, and further stratified anaemia as mild anaemia (Hct 33% to 36% for women, Hct 33% to 39% for men), and moderate to severe (Hct < 33% for both men and women). Univariate and multivariate analyses were used to evaluate the incidence of multiple adverse events within 30 days of arthroplasty. Results. Following adjustment, patients in the THA cohort with moderate to severe anaemia had an increased odds of 6.194 (95% confidence interval (CI) 5.679 to 6.756; p < 0.001) for developing any postoperative complication. Following adjustment, patients in the TKA cohort with moderate to severe anaemia had an increased odds of 5.186 (95% CI 4.811 to 5.590; p < 0.001) for developing any postoperative complication. Among both cohorts, as severity increased, there was an increased risk of postoperative complications. Conclusion. Preoperative anaemia is a risk factor for complications following primary arthroplasty. There is a significant relationship between the severity of anaemia and the odds of postoperative complications. Patients who had moderate to severe anaemia were at increased risk of developing postoperative complications relative to patients with mild anaemia. When considering elective primary THA or TKA in a moderately or severely anaemic patient, surgeons should strongly consider correcting anaemia prior to surgery if possible. Cite this article: Bone Joint J 2020;102-B(4):485–494


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 8 | Pages 1090 - 1092
1 Aug 2006
Odinsson A Finsen V

Over a two-year period, 265 Norwegian orthopaedic surgeons working at 71 institutions performed 63 484 operations under a tourniquet. Their replies to a questionnaire revealed that they mostly followed modern guidelines in their use of the tourniquet. Most felt that the tourniquet could be left on for two hours, and that it could be re-applied after 15 minutes. A total of 26 complications (one in 2442 operations) that might have been due to the tourniquet were reported, of which 15 were neurological. Three were in the upper limb (one in 6155 operations) and 12 in the lower limb (one in 3752 operations). Two were permanent (one in 31742 operations), but the remainder resolved within six months. One permanent and one transient complication occurred after tourniquet times of three hours. The incidence of tourniquet complications is still at least as high as that estimated in the 1970s


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1731 - 1735
1 Nov 2021
Iobst CA Frost MW Rölfing JD Rahbek O Bafor A Duncan M Kold S

Aims

Limb-lengthening nails have largely replaced external fixation in limb-lengthening and reconstructive surgery. However, the adverse events and high prevalence of radiological changes recently noted with the STRYDE lengthening nail have raised concerns about the use of internal lengthening nails. The aim of this study was to compare the prevalence of radiological bone abnormalities between STRYDE, PRECICE, and FITBONE nails prior to nail removal.

Methods

This was a retrospective case series from three centres. Patients were included if they had either of the three limb-lengthening nails (STYDE, PRECICE, or FITBONE) removed. Standard orthogonal radiographs immediately prior to nail removal were examined for bone abnormalities at the junction of the telescoping nail parts.


The Journal of Bone & Joint Surgery British Volume
Vol. 85-B, Issue 2 | Pages 178 - 181
1 Mar 2003
Møller AM Pedersen T Villebro N Munksgaard A

Smoking is an important risk factor for the development of postoperative pulmonary complications after major surgical procedures. We studied 811 consecutive patients who had undergone hip or knee arthroplasty, recording current smoking and drinking habits, any history of chronic disease and such intraoperative factors as the type of anaesthesia and the type and duration of surgery. We recorded any postoperative complications occurring before discharge from hospital. There were 232 smokers (28.6%) and 579 non-smokers. We found that smoking was the single most important risk factor for the development of postoperative complications, particularly those relating to wound healing, cardiopulmonary complications, and the requirement of postoperative intensive care. A delay in discharge from hospital was usual for those suffering a complication. In those patients requiring prolonged hospitalisation (> 15 days) the proportion of smokers with wound complications was twice that of non-smokers


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 1 | Pages 128 - 133
1 Jan 2012
Kim S Agashe MV Song S Choi H Lee H Song H

Lengthening of the humerus is now an established technique. We compared the complications of humeral lengthening with those of femoral lengthening and investigated whether or not the callus formation in the humerus proceeds at a higher rate than that in the femur. A total of 24 humeral and 24 femoral lengthenings were performed on 12 patients with achondroplasia. We measured the pixel value ratio (PVR) of the lengthened area on radiographs and each radiograph was analysed for the shape, type and density of the callus. The quality of life (QOL) of the patients after humeral lengthening was compared with that prior to surgery. The complication rate per segment of humerus and femur was 0.87% and 1.37%, respectively. In the humerus the PVR was significantly higher than that of the femur. Lower limbs were associated with an increased incidence of concave, lateral and central callus shapes. Humeral lengthening had a lower complication rate than lower-limb lengthening, and QOL increased significantly after humeral lengthening. Callus formation in the humerus during the distraction period proceeded at a significantly higher rate than that in the femur. . These findings indicate that humeral lengthening has an important role in the management of patients with achondroplasia


The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 5 | Pages 890 - 892
1 Sep 1999
Rickman M Saleh M Gaines PA Eyres K

Osteotomies are commonly carried out in orthopaedic surgery, particularly in limb reconstruction. Complications are uncommon provided that sufficient care is taken and a sound technique used. We describe three cases of formation of false aneurysm after osteotomy, with acute, delayed and asymptomatic onset. The diagnosis was supported by ultrasound investigation, and confirmed by angiography. Embolisation with coils was a successful method of treatment. We recommend a safe method of osteotomy with good bone exposure and adequate soft-tissue protection.


Bone & Joint Open
Vol. 4, Issue 7 | Pages 539 - 550
21 Jul 2023
Banducci E Al Muderis M Lu W Bested SR

Aims. Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. Methods. A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications. Results. A total of 19 studies were included: four one-stage, 14 two-stage, and one article with both one- and two-stage groups. Superficial infection was the most common complication (one-stage: 38% vs two-stage: 52%). There was a notable difference in the incidence of osteomyelitis (one-stage: nil vs two-stage: 10%) and implant failure (one-stage: 1% vs two-stage: 9%). Fracture incidence was equivocal (one-stage: 13% vs two-stage: 12%), and comparison of soft-tissue, stoma, and mechanical related complications was not possible. Conclusion. This review suggests that the one-stage approach is favourable compared to the two-stage, because the incidence of complications was slightly lower in the one-stage cohort, with a pertinent difference in the incidence of osteomyelitis and implant failure. Cite this article: Bone Jt Open 2023;4(7):539–550


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 293 - 302
1 Mar 2024
Vogt B Lueckingsmeier M Gosheger G Laufer A Toporowski G Antfang C Roedl R Frommer A

Aims. As an alternative to external fixators, intramedullary lengthening nails (ILNs) can be employed for distraction osteogenesis. While previous studies have demonstrated that typical complications of external devices, such as soft-tissue tethering, and pin site infection can be avoided with ILNs, there is a lack of studies that exclusively investigated tibial distraction osteogenesis with motorized ILNs inserted via an antegrade approach. Methods. A total of 58 patients (median age 17 years (interquartile range (IQR) 15 to 21)) treated by unilateral tibial distraction osteogenesis for a median leg length discrepancy of 41 mm (IQR 34 to 53), and nine patients with disproportionate short stature treated by bilateral simultaneous tibial distraction osteogenesis, with magnetically controlled motorized ILNs inserted via an antegrade approach, were retrospectively analyzed. The median follow-up was 37 months (IQR 30 to 51). Outcome measurements were accuracy, precision, reliability, bone healing, complications, and patient-reported outcome assessed by the Limb Deformity-Scoliosis Research Society Score (LD-SRS-30). Results. A median tibial distraction of 44 mm (IQR 31 to 49) was achieved with a mean distraction index of 0.5 mm/day (standard deviation 0.13) and median consolidation index of 41.2 days/cm (IQR 34 to 51). Accuracy, precision, and reliability were 91%, 92%, and 97%, respectively. New temporary range of motion limitations occurred in 51% of segments (34/67). Distraction-related equinus deformity treated by Achilles tendon lengthening was the most common major complication recorded in 16% of segments (11/67). In 95% of patients (55/58) the distraction goal was achieved with 42% unplanned additional interventions per segment (28/67). The median postoperative LD-SRS-30 score was 4.0 (IQR 3.6 to 4.3). Conclusion. Tibial distraction osteogenesis using motorized ILNs inserted via an antegrade approach appears to be a reliable and precise procedure. Temporary joint stiffness of the knee or ankle should be expected in up to every second patient. A high rate and wide range of complications of variable severity should be anticipated. Cite this article: Bone Joint J 2024;106-B(3):293–302


Bone & Joint Open
Vol. 4, Issue 12 | Pages 970 - 979
19 Dec 2023
Kontoghiorghe C Morgan C Eastwood D McNally S

Aims. The number of females within the speciality of trauma and orthopaedics (T&O) is increasing. The aim of this study was to identify: 1) current attitudes and behaviours of UK female T&O surgeons towards pregnancy; 2) any barriers faced towards pregnancy with a career in T&O surgery; and 3) areas for improvement. Methods. This is a cross-sectional study using an anonymous 13-section web-based survey distributed to female-identifying T&O trainees, speciality and associate specialist surgeons (SASs) and locally employed doctors (LEDs), fellows, and consultants in the UK. Demographic data was collected as well as closed and open questions with adaptive answering relating to attitudes towards childbearing and experiences of fertility and complications associated with pregnancy. A descriptive data analysis was carried out. Results. A total of 226 UK female T&O surgeons completed the survey. All regions of the UK were represented. Overall, 99/226 (44%) of respondents had at least one child, while 21/226 (9.3%) did not want children. Median age at first child was 33 years (interquartile range 32 to 36). Two-thirds (149/226; 66%) of respondents delayed childbearing due to a career in T&O and 140/226 (69%) of respondents had experienced bias from colleagues directed at female T&O surgeons having children during training. Nearly 24/121 (20%) of respondents required fertility assistance, 35/121 (28.9%) had experienced a miscarriage, and 53/121 (43.8%) had experienced obstetric complications. Conclusion. A large proportion of female T&O surgeons have and want children. T&O surgeons in the UK delay childbearing, have experienced bias and have high rates of infertility and obstetric complications. The information from this study will support female T&O surgeons with decision making and assist employers with workforce planning. Further steps are necessary in order to support female T&O surgeons having families. Cite this article: Bone Jt Open 2023;4(12):970–979


Bone & Joint Open
Vol. 3, Issue 1 | Pages 42 - 53
14 Jan 2022
Asopa V Sagi A Bishi H Getachew F Afzal I Vyrides Y Sochart D Patel V Kader D

Aims. There is little published on the outcomes after restarting elective orthopaedic procedures following cessation of surgery due to the COVID-19 pandemic. During the pandemic, the reported perioperative mortality in patients who acquired SARS-CoV-2 infection while undergoing elective orthopaedic surgery was 18% to 20%. The aim of this study is to report the surgical outcomes, complications, and risk of developing COVID-19 in 2,316 consecutive patients who underwent elective orthopaedic surgery in the latter part of 2020 and comparing it to the same, pre-pandemic, period in 2019. Methods. A retrospective service evaluation of patients who underwent elective surgical procedures between 16 June 2020 and 12 December 2020 was undertaken. The number and type of cases, demographic details, American society of Anesthesiologists (ASA) grade, BMI, 30-day readmission rates, mortality, and complications at one- and six-week intervals were obtained and compared with patients who underwent surgery during the same six-month period in 2019. Results. A total of 2,316 patients underwent surgery in 2020 compared to 2,552 in the same period in 2019. There were no statistical differences in sex distribution, BMI, or ASA grade. The 30-day readmission rate and six-week validated complication rates were significantly lower for the 2020 patients compared to those in 2019 (p < 0.05). No deaths were reported at 30 days in the 2020 group as opposed to three in the 2019 group (p < 0.05). In 2020 one patient developed COVID-19 symptoms five days following foot and ankle surgery. This was possibly due to a family contact immediately following discharge from hospital, and the patient subsequently made a full recovery. Conclusion. Elective surgery was safely resumed following the cessation of operating during the COVID-19 pandemic in 2020. Strict adherence to protocols resulted in 2,316 elective surgical procedures being performed with lower complications, readmissions, and mortality compared to 2019. Furthermore, only one patient developed COVID-19 with no evidence that this was a direct result of undergoing surgery. Level of evidence: III. Cite this article: Bone Jt Open 2022;3(1):42–53


Bone & Joint Open
Vol. 4, Issue 8 | Pages 643 - 651
24 Aug 2023
Langit MB Tay KS Al-Omar HK Barlow G Bates J Chuo CB Muir R Sharma H

Aims. The standard of wide tumour-like resection for chronic osteomyelitis (COM) has been challenged recently by adequate debridement. This paper reviews the evolution of surgical debridement for long bone COM, and presents the outcome of adequate debridement in a tertiary bone infection unit. Methods. We analyzed the retrospective record review from 2014 to 2020 of patients with long bone COM. All were managed by multidisciplinary infection team (MDT) protocol. Adequate debridement was employed for all cases, and no case of wide resection was included. Results. A total of 53 patients (54 bones) with median age of 45.5 years (interquartile range 31 to 55) and mean follow-up of 29 months (12 to 59) were included. In all, ten bones were Cierny-Mader type I, 39 were type III, and five were type IV. All patients were treated with single-staged management, except for one (planned two-stage stabilization). Positive microbial cultures grew in 75%. Overall, 46 cases (85%) had resolution of COM after index procedure, and 49 (90.7%) had resolution on last follow-up. Four patients (7%) underwent second surgical procedure and six patients (11%) had complications. Conclusion. We challenge the need for wide tumour-like resection in all cases of COM. Through detailed preoperative evaluation and planning with MDT approach, adequate debridement and local delivery of high concentration of antibiotic appears to provide comparable outcomes versus radical debridement. Cite this article: Bone Jt Open 2023;4(8):643–651


Bone & Joint Open
Vol. 2, Issue 9 | Pages 721 - 727
1 Sep 2021
Zargaran A Zargaran D Trompeter AJ

Aims. 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. Methods. 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. Results. Pooled analysis of four studies including 651 patients found the mean 25(OH)D level to be 50.7 nmol/l with a mean incidence of infection of 70%. There was a paucity of literature exploring prophylactic 25(OH)D supplementation on reducing orthopaedic infection, however, there was evidence of association between low 25(OH)D levels and increased incidence of orthopaedic infection. Conclusion. The results indicate a significant proportion of orthopaedic patients have low 25(OH]D levels, as well as an association between low 25(OH)D levels and orthopaedic infection, but more randomized controlled trials need to be conducted to establish the benefit of prophylactic supplementation and the optimum regimen by dose and time. Cite this article: Bone Jt Open 2021;2(9):721–727


Bone & Joint Open
Vol. 1, Issue 7 | Pages 415 - 419
15 Jul 2020
Macey ARM Butler J Martin SC Tan TY Leach WJ Jamal B

Aims. To establish if COVID-19 has worsened outcomes in patients with AO 31 A or B type hip fractures. Methods. Retrospective analysis of prospectively collected data was performed for a five-week period from 20 March 2020 and the same time period in 2019. The primary outcome was mortality at 30 days. Secondary outcomes were COVID-19 infection, perioperative pulmonary complications, time to theatre, type of anaesthesia, operation, grade of surgeon, fracture type, postoperative intensive care admission, venous thromboembolism, dislocation, infection rates, and length of stay. Results. In all, 76 patients with hip fractures were identified in each group. All patients had 30-day follow-up. There was no difference in age, sex, American Society of Anesthesiologists (ASA) classification or residence at time of injury. However, three in each group were not fit for surgery. No significant difference was found in 30-day mortality; ten patients (13%) in 2019 and 11 patients (14%) in 2020 (p = 0.341). In the 2020 cohort, ten patients tested positive for COVID-19, two (20%) of whom died. There was no significant increase in postoperative pulmonary complications. Median time to theatre was 20 hours (interquartile range (IQR) 16 to 25) in 2019 versus 23 hours (IQR 18 to 30) in 2020 (p = 0.130). Regional anaesthesia increased from 24 (33%) cases in 2019 to 46 (63%) cases in 2020, but ten (14%) required conversion to general anaesthesia. In both groups, 53 (70%) operations were done by trainees. Hemiarthroplasty for 31 B type fractures was the most common operation. No significant difference was found for intensive care admission or 30-day venous thromboembolism, dislocation or infection, or length of stay. Conclusion. Little information exists on mortality and complications after hip fracture during the COVID-19 pandemic. At the time of writing, no other study of outcomes in the UK has been published. Cite this article: Bone Joint Open 2020;1-7:415–419


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 88 - 96
1 Jan 2023
Vogt B Rupp C Gosheger G Eveslage M Laufer A Toporowski G Roedl R Frommer A

Aims

Distraction osteogenesis with intramedullary lengthening devices has undergone rapid development in the past decade with implant enhancement. In this first single-centre matched-pair analysis we focus on the comparison of treatment with the PRECICE and STRYDE intramedullary lengthening devices and aim to clarify any clinical and radiological differences.

Methods

A single-centre 2:1 matched-pair retrospective analysis of 42 patients treated with the STRYDE and 82 patients treated with the PRECICE nail between May 2013 and November 2020 was conducted. Clinical and lengthening parameters were compared while focusing radiological assessment on osseous alterations related to the nail’s telescopic junction and locking bolts at four different stages.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 146 - 157
7 Mar 2023
Camilleri-Brennan J James S McDaid C Adamson J Jones K O'Carroll G Akhter Z Eltayeb M Sharma H

Aims

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.

Methods

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.


Bone & Joint 360
Vol. 12, Issue 3 | Pages 43 - 43
1 Jun 2023
Das A

This edition of Cochrane Corner looks at some of the work published by the Cochrane Collaboration, covering interventions for treating distal femur fractures in adults; ultrasound and shockwave therapy for acute fractures in adults; and local corticosteroid injection versus placebo for carpal tunnel syndrome.


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 632 - 638
1 Jun 2024
Hart CM Kelley BV Mamouei Z Turkmani A Ralston M Arnold M Bernthal NM Sassoon AA

Aims

Delayed postoperative inoculation of orthopaedic implants with persistent wound drainage or bacterial seeding of a haematoma can result in periprosthetic joint infection (PJI). The aim of this in vivo study was to compare the efficacy of vancomycin powder with vancomycin-eluting calcium sulphate beads in preventing PJI due to delayed inoculation.

Methods

A mouse model of PJI of the knee was used. Mice were randomized into groups with intervention at the time of surgery (postoperative day (POD) 0): a sterile control (SC; n = 6); infected control (IC; n = 15); systemic vancomycin (SV; n = 9); vancomycin powder (VP; n = 21); and vancomycin bead (VB; n = 19) groups. Delayed inoculation was introduced during an arthrotomy on POD 7 with 1 × 105 colony-forming units (CFUs) of a bioluminescent strain of Staphylococcus aureus. The bacterial burden was monitored using bioluminescence in vivo. All mice were killed on POD 21. Implants and soft-tissue were harvested and sonicated for analysis of the CFUs.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1095 - 1100
1 Sep 2022
McNally MA Ferguson JY Scarborough M Ramsden A Stubbs DA Atkins BL

Aims

Excision of chronic osteomyelitic bone creates a dead space which must be managed to avoid early recurrence of infection. Systemic antibiotics cannot penetrate this space in high concentrations, so local treatment has become an attractive adjunct to surgery. The aim of this study was to present the mid- to long-term results of local treatment with gentamicin in a bioabsorbable ceramic carrier.

Methods

A prospective series of 100 patients with Cierny-Mader Types III and IV chronic ostemyelitis, affecting 105 bones, were treated with a single-stage procedure including debridement, deep tissue sampling, local and systemic antibiotics, stabilization, and immediate skin closure. Chronic osteomyelitis was confirmed using strict diagnostic criteria. The mean follow-up was 6.05 years (4.2 to 8.4).


Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

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 RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.