Advertisement for orthosearch.org.uk
Results 1 - 17 of 17
Results per page:
Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_19 | Pages 19 - 19
22 Nov 2024
Hanssen J Veerman K Van der Jagt O Somford M Lammers J Poolman R Peters E Visser J Bos K Verhagen R Vehmeijer S Zijlstra W Nolte P Wouthuyzen-Bakker M Mahdad R Vlasveld I De Boer MG Scheper H
Full Access

Aim

Rifampicin and fluoroquinolone based therapy is generally considered as first-choice targeted oral antimicrobial therapy for staphylococcal prosthetic joint infections (PJI) treated with debridement, antibiotics and implant retention (DAIR). Alternative equally effective antimicrobial strategies are urgently needed due to toxicity and drug-drug interactions that frequently occur with this strategy. Data from recent clinical studies suggests equipoise for other antimicrobial treatment regimens. The objective of the Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection (RiCOTTA)-trial is to evaluate whether monotherapy with clindamycin is non-inferior to rifampicin/fluoroquinolone combination therapy in patients with staphylococcal PJI that are treated with DAIR.

Method

The RiCOTTA-trial is a multicenter, non-inferiority, open-label, randomized controlled trial evaluating clindamycin versus rifampicin/fluoroquinolone combination therapy in the oral treatment phase in patients with staphylococcal PJI managed with DAIR. The trial is performed in 16 hospitals in the Netherlands. Eligible patients are adults with staphylococcal knee or hip PJI managed by DAIR. Patients are included one to six days before antibiotic treatment is switched from intravenous to oral therapy. Patients with a contraindication for rifampicin, with a megaprosthesis or who receive intravenous antibiotics for more than three weeks after initial debridement are excluded. Primary outcome is treatment success one year after finishing antimicrobial treatment. Success is defined as the absence of: i. Infection related re-surgery, ii. New episode of antibiotic treatment for infection of the index joint after the initial treatment phase of 12 weeks, iii. Ongoing use of antibiotics for the index joint at the end of follow-up, iv. Death. The estimated treatment success of rifampicin combination therapy is 85% and the monotherapy strategy is considered not inferior when the difference in treatment success will be less than 10%. Enrolment of 158 patients per group (316 in total) is needed to confirm non-inferiority of monotherapy with a power of 80%. The trial is currently open for enrolment. The study is approved by the Medical Ethics Committee Leiden, the Hague, Delft, the Netherlands and registered under EU trial number 2022-501620-26-00 in Clinical Trial Information System.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 42 - 42
19 Aug 2024
de Graeff JJ Kowalska J van der Pas SL van Leeuwen N Willigenburg NW Neve WC de Vries LMA Schreurs BW Nelissen RGHH van Steenbergen LN Poolman R
Full Access

Controversy persists over whether cemented or uncemented fixation is more effective in reducing revision and mortality risks following primary total hip arthroplasty (THA). Despite a shift towards uncemented THA in Europe, Australia, and the US, no consensus exists on superior outcomes. This ambiguity in evidence from randomized controlled trials (RCTs) and observational studies necessitates advanced research methodologies to derive more definitive conclusions.

This study investigates the causal impact of THA fixation type on 2-year and 5-year revision rates, along with 90-day mortality, utilizing a regression discontinuity (RD) design in scenarios where fixation choice is guided by patient age.

Employing data from the Dutch Arthroplasty Register, we conducted a cohort study on primary THAs for osteoarthritis from 2007 to 2019. A “fuzzy” RD design was executed to compute the Local Average Treatment Effect for subjects around the age-based selection threshold for fixation type. The main outcome of interest was the revision rate at 2 years post-operation.

Analysis for the 2-year revision endpoint, covering any cause, included 2,344 females and 1,671 males across 5 hospitals each, with no significant variation in revision rates observed. For the 5-year mark, 1,058 females in 3 hospitals and 214 males in 1 hospital were examined, similarly showing no significant differences. Mortality within 90 days post-operation was also investigated in 5 female and 7 male cohorts, with 2,180 and 2,145 surgeries respectively, yielding no substantial disparities.

In conclusion, the RD analysis revealed no notable differences in revision rates at 2 and 5 years or in early mortality based on the fixation method used in THA. These outcomes suggest that the age-based preference for THA fixation may not influence the revision or mortality risk, underscoring the value of RD design in deriving causal insights from observational data.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 53 - 53
23 Jun 2023
Schemitsch EH Nowak LL De Beer J Brink O Poolman R Mehta S Stengel D Bhandari M
Full Access

We aimed to use data from a randomized controlled trial (RCT) comparing the sliding hip screw vs. intramedullary nailing (IMN) for trochanteric fractures to examine complication rates between those managed with a short vs. long IMN.

This is a secondary analysis using one arm of an RCT of patients ≥18 years with trochanteric fractures. We examined differences in fracture-related (femoral shaft fracture, implant failure, surgical site infection (SSI), nonunion, limb shortening, and pain) and medical (organ failure, respiratory distress, stroke, deep vein thrombosis [DVT] gastrointestinal upset, pneumonia, myocardial infarction, sepsis, or urinary tract infection) adverse events (AE), and readmission between short vs. long IMNs.

We included 412 trochanteric fracture patients, 339 (82.2%) of whom received a short (170mm–200mm) nail, while 73 (17.7%) received a long (260mm–460 mm) nail. Patients in the long group were more likely to be admitted from home (vs. an institution), and have comorbidities, or more complex fracture types.

Patients in the long group had higher rates of fracture-related AE (12.3%) vs. the short group (3.5%). Specifically, SSI (5.5% vs. 0.3%) and pain (2.7% vs. 0.0%) were significantly higher in the long group. Patients in the long group were also more likely to develop DVT (2.7% vs. 0.3%), and be readmitted to the hospital (28.8% vs. 20.7%).

Following covariable adjustment, long nails remained associated with a higher odds of fracture-related AE (5.11, 1.96–13.33) compared to short nails. We found no association between the adjusted odds of readmission and nail length (1.00, 0.52–1.94).

Our analyses revealed that trochanteric fracture patients managed with long IMN nails may have a higher odds of fracture-related AE compared to short nails. Future research is required to validate these findings with larger event rates, and further optimize IMN for trochanteric fracture patients.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_10 | Pages 82 - 82
1 Oct 2022
Scheper H Mahdad R Elzer B Löwik C Zijlstra W Gosens T van der Lugt J van der Wal R Poolman R Somford M Jutte P Bos K Kooijman C Maree H Nelissen R Visser LG De Boer MG
Full Access

Background

The duration and extent of postoperative wound leakage after joint arthroplasty in patients with or without a complicated course, like a prosthetic joint infection (PJI), is currently unknown. Adequate differentiation between normal postoperative wound leakage and wound leakage due to a postoperative PJI is important and prevents unnecessary surgical procedures. We investigated the association between postoperative wound leakage and development of PJI in patients who used a previously developed mobile wound care app.

Methods

A multicenter, prospective cohort study with patients aged 18 years or older after primary implantation or revision of a total joint arthroplasty. During 30 post-operative days after arthroplasty, patients recorded their wound status in the woundcare app. An algorithm calculated a daily score from imputed data. If the daily score exceeded a predefined threshold, the patients received an alert that advised them to contact their physician.


Bone & Joint Open
Vol. 3, Issue 8 | Pages 611 - 617
1 Aug 2022
Frihagen F Comeau-Gauthier M Axelrod D Bzovsky S Poolman R Heels-Ansdell D Bhandari M Sprague S Schemitsch E

Aims

The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population.

Methods

We performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 101 - 101
1 Nov 2018
Veltman E Lenguerrand E Moojen D Whitehouse M Nelissen R Blom A Poolman R
Full Access

Administration of perioperative antibiotic prophylaxis (AP) reduces the risk of prosthetic joint infection (PJI) following primary total hip (THA) and knee (TKA) arthroplasty. The optimal type of antibiotic used, and duration of prophylaxis are subject to debate. We compared the risk of revision surgery for PJI in the first year following THA and TKA by AP regimen. A national survey collecting information on hospital-level AP regimen policy was conducted across the Netherlands and linked to data from the LROI arthroplasty registry for 2011–2015. PJI status was defined using the surgical indication reported at revision by surgeons in the registry form. Restricted cubic splines Poisson model adjusted for hospital clustering were used to conduct the comparisons on 130,712 THAs and 111,467 TKAs performed across 99 institutions. These included 399 THAs and 303 TKAs revised for an indication of PJI. Multiple shot of Cefazolin (MCZ), of cefuroxime (MCX) and single shot of Cefazolin (SCZ) were respectively administrated to 87%, 4% and 9% of patients. For THA, the rates of revision for PJI were respectively 31/10,000 person-years 95%CI[28, 35], 39[25, 59] and 23[15, 34] in the groups which received MCZ, MCX and SCZ; respectively, the rates for TKA were 27[24, 31], 40[24, 62] and 24[16, 36]. No evidence of difference between AP regimens was found in the unadjusted and adjusted model (age, gender, BMI and ASA grade). Further work is advocated to confirm whether there is an association between AP regimen collected at patient-level and the risk of subsequent revision for PJI.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_15 | Pages 12 - 12
1 Dec 2015
Veltman E Moojen D Glehr M Poolman R
Full Access

Joint replacement is a highly effective intervention to treat osteoarthritis of the hip, relieving pain and improving mobility and quality of life.(1) Periprosthetic joint infection (PJI) is a devastating complication after arthroplasty. Debridement, antibiotics and implant retention are treatment of first choice in case of early infection after total hip arthroplasty (THA).(2) In case of persisting infection, one- or two-stage revision needs to be performed.(3) The use of different kinds of spacers has been widely debated in the past years.(4)

The aim of this study was to determine which type of spacer should be used during the interval of two-stage revision of an infected THA.

A search term with Boolean operators was constructed. We extracted all information regarding study and patient characteristics and baseline clinical and laboratory findings. Data regarding type of spacer and antibiotics used, timing of second stage surgery, tissue culture results, postoperative regimen, functional outcome and patient satisfaction were extracted.

A total of twenty-six studies met our inclusion criteria and were included for data analysis. Ten studies described various preformed spacers, six studies described functional spacers and eleven studies described custom made spacers. See Table 1 for results.

Research should focus on finding the preferred type of treatment and type of spacer to combine a high success rate of infection treatment with a good functional and patient reported outcome. There is a need for a prospective study evaluating patient satisfaction and functional outcome after two-stage revision THA comparing various spacers. Secondly, research should focus on the optimal timing of the second stage procedure.

Functional spacers achieve a comparable rate of infection eradication in the treatment of periprosthetic hip joint infections as compared to preformed spacers. There is insufficient evidence concerning rehabilitation and functional outcome after two-stage revisionTHA to advocate or discourage the use of either kind of interval spacer.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 202 - 202
1 Sep 2012
Van Der Weegen W Hoekstra H Sijbesma T Bos E Schemitsch E Poolman R
Full Access

Introduction

Hip resurfacing arthroplasty (HRA) has seen a recent revival with third generation Metal-on-Metal prostheses and is now widely in use. However, safety and effectiveness of hip resurfacing are still questioned. We systematically reviewed peer-reviewed literature on hip resurfacing arthroplasty to evaluate implant survival and functional outcomes of hybrid Metal-on-Metal hip resurfacing Arthroplasty.

Method

Electronic databases and reference lists were searched from 1988 to September 2009. Identified abstracts were checked for inclusion or exclusion by two independent reviewers. Data were extracted and summarized by one reviewer and verified by a second reviewer. Main study endpoint was implant survival, which we compared with the National Institute of Clinical Excellence (NICE) benchmark. We also evaluated radiological and functional outcomes, failure modes and other adverse events.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 152 - 152
1 Sep 2012
Van Der Weegen W Hoekstra H Sybesma T Bos E Schemitsch E Poolman R
Full Access

Background

Hip resurfacing arthroplasty (HRA) has seen a recent revival with third generation Metal-on-Metal prostheses and is now widely in use. However, safety and effectiveness of hip resurfacing are still questioned. We systematically reviewed peer-reviewed literature on hip resurfacing arthroplasty to address these issues.

Objective

To evaluate implant survival and functional outcomes of hybrid Metal-on-Metal hip resurfacing arthroplasty (HRA).


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 583 - 583
1 Nov 2011
Goulding K Poolman R Schemitsch EH Bhandari M Petrisor B
Full Access

Purpose: To determine the effect of reamed versus non-reamed intramedullary (IM) nailing of femoral diaphyseal fractures on the rates of non-union and acute respiratory distress syndrome (ARDS).

Method: We searched the online databases of OVID, MEDLINE, EMBASE, PubMed, and the Cochrane collaboration for randomized clinical trials (RCT) from 1998 to 2009. Additional studies were identified by hand searches of major orthopaedic journals, reference lists of eligible studies, SCISEARCH, and title reviews of presentations from major orthopaedic trauma meetings. Inclusion criteria were trials evaluating the effect of reamed versus nonreamed closed interlocked intra-medullary nailing of femoral diaphyseal fractures on the rates of nonunion or acute respiratory distress syndrome (ARDS) in skeletally mature adults. Exclusion criteria included patients with pathologic fractures, skeletally immature patients, as well as observational and other non-randomized studies.

Results: Seventy-two citations were initially identified out of 1,147 studies. 6 studies matched all eligibility criteria as assessed by three independent reviewers. A total of 941 patients with 956 femoral diaphyseal fractures treated with intramedullary nailing met the eligibility criteria. The relative risk of non-union (four trials, n= 456 patients) was 0.29 [95% confidence interval (CI), 0.14 to 0.57; p< 0.00001] (ie. a 70% relative risk reduction of nonunion) in favour of a reamed intramedullary nail There was no significant difference in the rates of ARDS following reamed or non-reamed nailing, relative risk for ARDS (two trials, n=397) 1.10 [95% CI, 0.27 to 4.54, p=0.18].

Conclusion: The study suggests that reamed intramedullary nailing of femoral diaphyseal fractures significantly reduces the risk of non-union as compared to nonreaming. The risk of ARDS was not statistically significant between groups; however there was a slight trend towards ARDS iwith reamed IM fixation.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 164 - 164
1 May 2011
Buijze G Doornberg J Ham J Ring D Bhandari M Poolman R
Full Access

Background: Traditionally, non-displaced scaphoid fractures are considered by most as stable with predictable rates of healing with conservative treatment. There is a current trend in orthopedic practice, however, to treat non- or minimal displaced fractures with early open reduction and internal fixation. This trend is not evidence based. In this systematic review and meta-analysis, we pool data from trials comparing surgical and conservative treatment for acute scaphoid fractures, thus aiming to summarize the best available evidence.

Methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and reference list of articles, and contacted researchers in the field. We selected eight randomized controlled trials comparing surgical versus conservative interventions for acute scaphoid fractures in adults. Data were pooled using fixed-effects and randomeffects models with standard mean differences (SMD) and risk ratios for continuous and dichotomous variables respectively. Heterogeneity across studies was assessed with Forest plots and calculation of the I2 statistic.

Results: Four-hundred seventeen patients were included in eight trials (205 fractures were treated surgically and 212 conservatively). Most trials lacked scientific rigor. Four studies assessed functional outcome with validated physician- and patient-based outcome instruments. With the numbers available (200 patients), we found a significant difference according to our primary outcome measure, standardized patient-based outcome in favor of surgical treatment (p< 0.0001). With regard to our secondary parameters, we found heterogeneous results that favored surgical treatment for grip strength, time to union and time off work. In contrast we found no significant differences between surgical and conservative treatment for pain, range of motion, rate of nonunion, malunion, and infection, rate of complications, and total treatment costs.

Conclusions: Patient-rated functional outcome and satisfaction as well as time to return to function favored surgical treatment for acute scaphoid fractures. However, there is no evidence from prospective randomized controlled trials on physician-rated functional outcome, radiographic outcome, complication rates and treatment costs to favor surgical or conservative treatment for acute scaphoid fractures.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 582 - 583
1 Oct 2010
Wei D Bhandari M Poolman R Rosenwasser M Wolfe V
Full Access

Background: There is no consensus on the surgical management of unstable distal radius fractures. In this systematic review and meta-analysis, we pool data from trials comparing external fixation and internal fixation for treatment of this injury.

Methods: We searched electronic databases and conference proceedings for published and unpublished trials. Two authors independently screened titles and s, reviewed manuscripts, graded methodological quality, and extracted all relevant information from eligible studies. Data were pooled using fixed-effects and random-effects models with standard mean differences (SMD) and risk ratios for continuous and dichotomous variables, respectively. Heterogeneity across studies was assessed with Forest plots and calculation of the I2 statistic. Subgroup analyses were defined a priori and performed where appropriate.

Results: We pooled data from nine comparative trials, totaling 750 patients (360 fractures treated with external fixation and 397 with internal fixation). Initially, we found substantial heterogeneity between studies and no significant difference according to our primary outcome measure, validated patient-reported outcomes (SMD=0.20, 95% confidence interval=[−0.12, 0.51], p=0.22, I2=65%). However, when we grouped studies by plate type, we eliminated heterogeneity within each subgroup and found locking volar plates demonstrated significantly better patient-reported outcomes compared to external fixation (SMD=1.30, 95% CI=[0.74, 1.86], p< 0.00001, I2=0%). Additionally, we found internal fixation yielded significantly better recovery of forearm supination and restoration of volar tilt (SMD=0.31, 95% CI=[0.15, 0.47], p=0.0002, I2=0; SMD=0.57, 95% CI=[0.57, 0.78], p< 0.00001, I2=0, respectively). Subgroup analyses showed external fixation yielded better wrist flexion among randomized studies (SMD= 0.43, p< 0.003, 95% CI=[ 0.67, 0.20], I2=0), and there was no significant difference in grip strength among studies with high methodological quality (SMD= 0.08, 95% CI=[−0.34, 0.18], p=0.54, I2=0%).

Conclusions: Open reduction and internal fixation of unstable distal radius fractures yields greater recovery of forearm supination, better restoration of anatomic volar tilt, and, for locking volar plates in particular, superior patient-reported function. External fixation may result in better wrist flexion, but no difference exists in terms of grip strength.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 499 - 499
1 Oct 2010
Siebelt M Bhandari M Bloem R Pilot P Poolman R Siebelt T
Full Access

Background: One of the disadvantages of the Impact Factor (IF) is self-citation. The SCImago Journal Rank (SJR) indicator excludes self-citations and incorporates quality of citations that a journal receives by other journals, rather than absolute numbers. This study re-evaluated self-citation influence on the 2007 IF for 17 major orthopaedic journals and the difference in ranking using IF or SJR was investigated.

Methods: Divided in a general (n = 8) and specialized (n = 9) group, all journals were analysed for self-citation rate, self-cited rate and citation density. Rankings of the 17 journals for IF and SJR were determined and the difference in ranking was calculated.

Results: Specialized journals had higher self-citation rates (p = 0.05), self-cited rates (p = 0.003) and lower citation-densities (p = 0.01). Both groups correlated for self-citation rate and impact factor (general: r = 0.85 ; p = 0.008) (specialized: r = 0.71 ; p = 0.049).

When ranked for SJR instead of IF, five journals maintained rank, six improved their rank and six experienced a decline in rank. Biggest differences were seen for BMC MD (+7 places) and CORR (− 4 places). Group-analyses for the IF (general: 7.50 – 95%CI 3.19 to 11.81) (specialized: 10.33 – 95%CI 6.61 to 14.06) (p = 0.26), SJR (general: 6.63 – 95%CI 2.66 to 10.60) (specialized: 11.11 – 95%CI 7.62 to 14.60) (p = 0.07) and the difference between both rankings (general: 0.88 – 95%CI –1.75 to 3.50) (specialized: − 0.78 – 95%CI –2.20 to 0.65) (p = 0.20), showed an enhanced underestimation of sub-specialist journals.

Conclusion: Citation analysis shows that general journals tend to use more citations per published article and a larger portion of self-citations constitutes citations of sub-specialist journals compared to more general journals. The SJR excludes the influence of self-citation and awarded prestige by the SJR implies a different quality-evaluation for most orthopaedic journals. A disadvantage using this indicator, is an enhanced effect of underestimation of sub-specialist journals.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 17 - 17
1 Mar 2009
Poolman R Keijser L de Waal Malefijt M Blankevoort L Farrokhyar F Bhandari M
Full Access

Background: The selection of presentations at orthopedic meetings is an important process. If the peer reviewers do not consistently agree on the quality score, the review process is arbitrary and open to bias. The aim of this study was:

1) To describe the inter reviewer agreement of a previously designed scoring scheme to rate abstracts submitted for presentation at the Dutch Orthopedic Association.

2) To test if quality of reporting of submitted abstracts increased in the years after the introduction of the scoring scheme.

3) To examine if a review process with a larger workload had lower inter rater agreement.

Methods: We calculated intraclass correlation coefficients (ICC) to measure the level of agreement among reviewers using the International Society of the Knee (ISK) abstract quality of reporting system. Acceptance rate and quality of the abstracts are described.

Results: Of 419 abstracts 229 (55%) were accepted. Inter-reviewer agreement to rate abstracts was substantial 0.68 (95%CI 0.47, 0.83) to almost perfect 0.95 (95%CI 0.92, 0.97) and did not change over the eligible time period. Less abstracts were accepted after 2004 (p = 0.039). The mean ISK abstract score, maximally 100 points, for accepted abstracts ranged from 60.4 (95%CI 57.7, 63.0) to 63.8 (95% CI 62.0, 65.7). The mean ISK abstract score for rejected abstracts varied from 45.8 (95%CI 40.3, 51.2) to 50.6 (95% CI 46.5, 54.8). Both scores for accepted and rejected abstracts did not change over time. Workload of the reviewers did not influence their level of agreement (p=0.167).

Interpretation: The ISK abstract rating system has an excellent inter observer agreement. Other scientific orthopedic meetings could adopt this ISK rating system for further evaluation in local or international setting.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 18 - 18
1 Mar 2009
Poolman R Struijs P Krips R Sierevelt I Marti R Farrokhyar F Zlowodzki M Bhandari M
Full Access

Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:

1) to examine the reporting of outcome measures in orthopaedic trials,

2) to determine the feasibility of blinding in published orthopaedic trials and

3) to examine the association between the magnitude of treatment differences and methodological safeguards such as blinding.

Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?

Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:

1) the outcome measures used and

2) the use of a methodological safeguard: blinding.

We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors.

Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies.

Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 18 - 18
1 Mar 2009
Poolman R Struijs P Krips R Sierevelt I Lutz K Zlowodzki M Bhandari M
Full Access

Background: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals.

Methods: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the four highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score.

Results: We found that only the Journal of Bone and Joint Surgery–American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p> 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC=0.80, 95%CI:0.60 to 0.90).

Conclusions: Our findings suggest that readers should not assume that

1) studies labelled as Level I have high reporting quality and

2) Level I studies have better reporting quality than Level II studies.

One should address methodological safeguards individually.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 111 - 112
1 Mar 2009
Poolman R Sierevelt I Farrokhyar F Mazel J Blankevoort L Zlowodzki M Bhandari M
Full Access

Background: The Journal of Bone and Joint Surgery, American Edition (the Journal) recently initiated a section called “Evidence-Based Orthopaedics”. Furthermore, a Levels of Evidence rating is now used in the Journal to help readers in clinical decision-making. Little is known if this recent emphasis of Evidence-based Medicine (EBM) influenced surgeons’ perceptions about and competence in evidence-based medicine. Therefore, we examined perceptions and competence in evidence-based medicine among Dutch orthopaedic surgeons.

Methods: Members of the Dutch Orthopaedic Association were surveyed to examine surgeons’ attitudes towards evidence-based medicine and competence in evidence-based medicine. We evaluated perceptions using a newly developed instrument tailored to surgical practice. Univariate analysis, and a multivariable analysis using Generalized Estimating Equations were performed to model the competence instrument.

Results: 367 Surgeons responded (60%). Orthopaedic surgeons welcomed evidence-based medicine. Practical evidence-based medicine resources were perceived as the best methods to move from eminence-based to evidence-based practice. Four variables were significantly and positively associated with the competence instrument:

1) younger age, particularly age between 36 and 45 years,

2) experience of less than 10 years,

3) having a PhD degree, and

4) working in an academic or teaching setting.

The majority of the respondents (65%) were aware of the Journal’s evidence-based medicine section, and 20% used the Journal’s evidence-based medicine abstracts in clinical decision-making. This increased awareness in evidence-based medicine was also reflected in a frequent use of Cochrane reviews in clinical decision-making (27%). Surgeons who used the Journal’s evidence-based medicine abstracts and Cochrane reviews had significantly higher competence scores.

Conclusions: Evidence-based medicine is welcomed by Dutch orthopaedic surgeons. Recent emphasis of evidence-based medicine is reflected in an increased awareness about the Journal’s evidence-based medicine section, Levels of Evidence, and the largest evidence-based medicine resource: Cochrane reviews. Younger orthopaedic surgeons had better knowledge about evidence-based medicine. Development and use of evidence-based resources as well as pre-appraised summaries like the Journal’s evidence-based medicine abstracts and Cochrane reviews were perceived as the best way to move from eminence based- to evidence-based orthopaedic practice.