The October 2024 Shoulder & Elbow Roundup360 looks at: Proximal humeral fractures with vascular compromise; Outcomes and challenges of revision arthroscopic rotator cuff repair: a systematic review; Evaluating treatment effectiveness for lateral elbow tendinopathy: a systematic review and network meta-analysis; Tendon transfer techniques for irreparable subscapularis tears: a comparative review; Impact of subscapularis repair in reverse shoulder arthroplasty; Isolated subscapularis tears strongly linked to shoulder pseudoparesis; Nexel and Coonrad-Morrey total elbow arthroplasties show comparable revision rates in New Zealand study; 3D MRI matches 3D CT in assessing bone loss and shoulder morphology in dislocation cases.
The Cartiva synthetic cartilage implant (SCI) entered mainstream use in the management of first metatarsophalangeal joint (MTPJ) arthritis following the positive results of large trials in 2016. Limited information is available on the longer-term outcomes of this implant within the literature, particularly when independent from the originator. This single-centre cohort study investigates the efficacy of the Cartiva SCI at up to five years. First MTPJ arthritis was radiologically graded according to the Hattrup and Johnson (HJ) classification. Preoperative and sequential postoperative patient-reported outcome measures (PROMs) were evaluated using the Manchester-Oxford Foot Questionnaire (MOXFQ), and the activities of daily living (ADL) sub-section of the Foot and Ankle Ability Measure (FAAM).Aims
Methods
Aims.
Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient’s blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA. A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months).Aims
Methods
The August 2024 Hip & Pelvis Roundup360 looks at: Understanding perceived leg length discrepancy post-total hip arthroplasty: the role of pelvic obliquity; Influence of femoral stem design on revision rates in total hip arthroplasty; Outcomes of arthroscopic labral treatment of femoroacetabular impingement in adolescents; Characteristics and quality of online searches for direct anterior versus posterior approach for total hip arthroplasty; Rapid return to braking after anterior and posterior approach total hip arthroplasty; How much protection does a collar provide?; Timing matters: reducing infection risk in total hip arthroplasty with corticosteroid injection intervals; Identifying pain recovery patterns in total hip arthroplasty using PROMIS data.
Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common
The aim of this study is to evaluate the surgical treatment with the best healing rate for patients with proximal femoral unicameral bone cysts (UBCs) after initial surgery, and to determine which procedure has the lowest adverse event burden during follow-up. This multicentre retrospective study was conducted in 20 tertiary paediatric hospitals in France, Belgium, and Switzerland, and included patients aged < 16 years admitted for UBC treatment in the proximal femur from January 1995 to December 2017. UBCs were divided into seven groups based on the index treatment, which included elastic stable intramedullary nail (ESIN) insertion with or without percutaneous injection or grafting, percutaneous injection alone, curettage and grafting alone, and insertion of other orthopaedic hardware with or without curettage.Aims
Methods
With up to 40% of patients having patellofemoral joint osteoarthritis (PFJ OA), the two arthroplasty options are to replace solely the patellofemoral joint via patellofemoral arthroplasty (PFA), or the entire knee via total knee arthroplasty (TKA). The aim of this study was to assess postoperative success of second-generation PFAs compared to TKAs for patients treated for PFJ OA using patient-reported outcome measures (PROMs) and domains deemed important by patients following a patient and public involvement meeting. MEDLINE, EMBASE via OVID, CINAHL, and EBSCO were searched from inception to January 2022. Any study addressing surgical treatment of primary patellofemoral joint OA using second generation PFA and TKA in patients aged above 18 years with follow-up data of 30 days were included. Studies relating to OA secondary to trauma were excluded. ROB-2 and ROBINS-I bias tools were used.Aims
Methods
The October 2023 Spine Roundup. 360. looks at: Cutting through surgical smoke: the science of cleaner air in spinal operations; Unlocking success: key factors in thoracic spine decompression and fusion for ossification of the posterior longitudinal ligament; Deep learning algorithm for identifying cervical cord compression due to degenerative canal stenosis on radiography; Surgeon experience influences robotics learning curve for minimally invasive lumbar fusion; Decision-making algorithm for the surgical treatment of degenerative lumbar spondylolisthesis of L4/L5; Response to preoperative
The August 2023 Spine Roundup360 looks at: Changes in paraspinal muscles correspond to the severity of degeneration in patients with lumbar stenosis;
The August 2023 Shoulder & Elbow Roundup360 looks at: Motor control or strengthening exercises for rotator cuff-related shoulder pain? A multi-arm randomized controlled trial; Does the choice of antibiotic prophylaxis influence reoperation rate in primary shoulder arthroplasty?; Common shoulder injuries in sport: grading the evidence; The use of medial support screw was associated with axillary nerve injury after plate fixation of proximal humeral fracture using a minimally invasive deltoid-splitting approach; MRI predicts outcomes of conservative treatment in patients with lateral epicondylitis; Association between surgeon volume and patient outcomes after elective shoulder arthroplasty; Arthroscopic decompression of calcific tendinitis without cuff repair; Functional outcome after nonoperative management of minimally displaced greater tuberosity fractures and predictors of poorer patient experience.
The August 2023 Wrist & Hand Roundup360 looks at: Complications and patient-reported outcomes after trapeziectomy with a Weilby sling: a cohort study; Swelling, stiffness, and dysfunction following proximal interphalangeal joint sprains; Utility of preoperative MRI for assessing proximal fragment vascularity in scaphoid nonunion; Complications and outcomes of operative treatment for acute perilunate injuries: a systematic review; The position of the median nerve in relation to the palmaris longus tendon at the wrist: a study of 784 MR images; Basal fractures of the ulnar styloid? A randomized controlled trial; Proximal row carpectomy versus four-corner arthrodesis in SLAC and SNAC wrist; Managing cold intolerance after hand injury: a systematic review.
The June 2023 Shoulder & Elbow Roundup. 360. looks at: Proximal humerus fractures: what does the literature say now?; Infection risk of
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 April 2023 Spine Roundup. 360. looks at: Percutaneous transforaminal endoscopic discectomy versus microendoscopic discectomy; Spine surgical site infections: a single debridement is not enough; Lenke type 5, anterior, or posterior: systematic review and meta-analysis; Epidural
The April 2023 Wrist & Hand Roundup360 looks at: MRI-based classification for acute scaphoid injuries: the OxSMART; Deep learning for detection of scaphoid fractures?; Ulnar shortening osteotomy in adolescents; Cost-utility analysis of thumb carpometacarpal resection arthroplasty; Arthritis of the wrist following scaphoid fracture nonunion; Extensor hood injuries in elite boxers; Risk factors for reoperation after flexor tendon repair; Nonoperative versus operative treatment for displaced finger metacarpal shaft fractures.
Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB. The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376.Aims
Methods
The February 2023 Wrist & Hand Roundup. 360. looks at: ‘Self-care’ protocol for minimally displaced distal radius fractures; Treatment strategies for acute Seymour fractures in children and adolescents: including crushed open fractures; Routinely collected outcomes of proximal row carpectomy; Moving minor hand surgeries in the office-based procedure room: a population-based trend analysis; A comparison between robotic-assisted scaphoid screw fixation and a freehand technique for acute scaphoid fracture: a randomized, controlled trial; Factors associated with conversion to surgical release after a
Tennis elbow (lateral epicondylitis or lateral elbow tendinopathy) is a self-limiting condition in most patients. Surgery is often offered to patients who fail to improve with conservative treatment. However, there is no evidence to support the superiority of surgery over continued nonoperative care or no treatment. New evidence also suggests that the prognosis of tennis elbow is not influenced by the duration of symptoms, and that there is a 50% probability of recovery every three to four months. This finding challenges the belief that failed nonoperative care is an indication for surgery. In this annotation, we discuss the clinical and research implications of the benign clinical course of tennis elbow. Cite this article:
Injury to the triangular fibrocartilage complex (TFCC) may result in ulnar wrist pain with or without instability. One component of the TFCC, the radioulnar ligaments, serve as the primary soft-tissue stabilizer of the distal radioulnar joint (DRUJ). Tears or avulsions of its proximal, foveal attachment are thought to be associated with instability of the DRUJ, most noticed during loaded pronosupination. In the absence of detectable instability, injury of the foveal insertion of the radioulnar ligaments may be overlooked. While advanced imaging techniques such as MRI and radiocarpal arthroscopy are well-suited for diagnosing central and distal TFCC tears, partial and complete foveal tears without instability may be missed without a high degree of suspicion. While technically challenging, DRUJ arthroscopy provides the most accurate method of detecting foveal abnormalities. In this annotation the spectrum of foveal injuries is discussed and a modified classification scheme is proposed. Cite this article:
Perthes’ disease (PD) is a childhood hip disorder that can affect the quality of life in adulthood due to femoral head deformity and osteoarthritis. There is very little data on how PD patients function as adults, especially from the patients’ perspective. The purpose of this study was to collect treatment history, demographic details, the University of California, Los Angeles activity score (UCLA), the 36-Item Short Form survey (SF-36) score, and the Hip disability and Osteoarthritis Outcome score (HOOS) of adults who had PD using a web-based survey method and to compare their outcomes to the outcomes from an age- and sex-matched normative population. The English REDCap-based survey was made available on a PD study group website. The survey included childhood and adult PD history, UCLA, SF-36, and HOOS. Of the 1,182 participants who completed the survey, the 921 participants who did not have a total hip arthroplasty are the focus of this study. The mean age at survey was 38 years (SD 12) and the mean duration from age at PD onset to survey participation was 30.8 years (SD 12.6).Aims
Methods
The December 2022 Wrist & Hand Roundup360 looks at: Anti-tumour necrosis factor therapy for early-stage Dupuytren’s disease; Patient experiences of scaphoid waist fractures and their treatment; Postoperative complications following open a1 pulley release for a trigger finger or thumb; How certain are findings in distal radius fractures: a systematic review of randomized controlled trials; Partial wrist denervation in wrist osteoarthritis: patient-reported outcomes and objective function; Dorsal bridge plating versus bridging external fixation for management of complex distal radius fractures; How is reduction lost in distal radius fractures in females aged 50 years and older; The HAND-Q: psychometrics of a new patient-reported outcome measure for clinical and research applications.
To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.Aims
Methods
There remains a lack of consensus regarding the management of chronic anterior sternoclavicular joint (SCJ) instability. This study aimed to assess whether a standardized treatment algorithm (incorporating physiotherapy and surgery and based on the presence of trauma) could successfully guide management and reduce the number needing surgery. Patients with chronic anterior SCJ instability managed between April 2007 and April 2019 with a standardized treatment algorithm were divided into non-traumatic (offered physiotherapy) and traumatic (offered surgery) groups and evaluated at discharge. Subsequently, midterm outcomes were assessed via a postal questionnaire with a subjective SCJ stability score, Oxford Shoulder Instability Score (OSIS, adapted for the SCJ), and pain visual analogue scale (VAS), with analysis on an intention-to-treat basis.Aims
Methods
Aims. The aim of this retrospective study was to evaluate the rate of conversion to surgical release after a
To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation. We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or ‘group’) response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional.Aims
Methods
Perthes’ disease is an uncommon hip disorder with limited data on the long-term outcomes in adulthood. We partnered with community-based foundations and utilized web-based survey methodology to develop the Adult Perthes Survey, which includes demographics, childhood and adult Perthes’ disease history, the University of California Los Angeles (UCLA) Activity Scale item, Short Form-36, the Hip disability and Osteoarthritis Outcome Score, and a body pain diagram. Here we investigate the following questions: 1) what is the feasibility of obtaining > 1,000 survey responses from adults who had Perthes’ disease using a web-based platform?; and 2) what are the baseline characteristics and demographic composition of our sample? The survey link was available publicly for 15 months and advertised among support groups. Of 1,505 participants who attempted the Adult Perthes survey, 1,182 completed it with a median timeframe of 11 minutes (IQR 8.633 to 14.72). Participants who dropped out were similar to those who completed the survey on several fixed variables. Participants represented 45 countries including the USA (n = 570; 48%), UK (n = 295; 25%), Australia (n = 133; 11%), and Canada (n = 46; 4%). Of the 1,182 respondents, 58% were female and the mean age was 39 years (SD 12.6).Aims
Methods
The primary aim of this study was to describe long-term patient-reported outcomes after ulna shortening osteotomy for ulna impaction syndrome. Overall, 89 patients treated between July 2011 and November 2017 who had previously taken part in a routine outcome evaluation up to 12 months postoperatively were sent an additional questionnaire in February 2021. The primary outcome was the Patient-Rated Wrist and Hand Evaluation (PRWHE) total score. Secondary outcomes included patient satisfaction with treatment results, complications, and subsequent treatment for ulnar-sided wrist pain. Linear mixed models were used to compare preoperative, 12 months, and late follow-up (ranging from four to nine years) PRWHE scores.Aims
Methods
Aims. Cervical radiculopathy is a significant cause of pain and morbidity. For patients with severe and poorly controlled symptoms who may not be candidates for surgical management, treatment with transforaminal epidural
Corticosteroid injections are often used to manage glenohumeral arthritis in patients who may be candidates for future total shoulder arthroplasty (TSA) or reverse shoulder arthroplasty (rTSA). In the conservative management of these patients, corticosteroid injections are often provided for symptomatic relief. The purpose of this study was to determine if the timing of corticosteroid injections prior to TSA or rTSA is associated with changes in rates of revision and periprosthetic joint infection (PJI) following these procedures. Data were collected from a national insurance database from January 2006 to December 2017. Patients who underwent shoulder corticosteroid injection within one year prior to ipsilateral TSA or rTSA were identified and stratified into the following cohorts: < three months, three to six months, six to nine months, and nine to 12 months from time of corticosteroid injection to TSA or rTSA. A control cohort with no corticosteroid injection within one year prior to TSA or rTSA was used for comparison. Univariate and multivariate analyses were conducted to determine the association between specific time intervals and outcomes.Aims
Methods
Aims. Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results. A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of
Access to total knee arthroplasty (TKA) is sometimes restricted for patients with severe obesity (BMI ≥ 40 kg/m2). This study compares the cost per quality-adjusted life year (QALY) associated with TKA in patients with a BMI above and below 40 kg/m2 to examine whether this is supported. This single-centre study compared 169 consecutive patients with severe obesity (BMI ≥ 40 kg/m2) (mean age 65.2 years (40 to 87); mean BMI 44.2 kg/m2 (40 to 66); 129/169 female) undergoing unilateral TKA to a propensity score matched (age, sex, preoperative Oxford Knee Score (OKS)) cohort with a BMI < 40 kg/m2 in a 1:1 ratio. Demographic data, comorbidities, and complications to one year were recorded. Preoperative and one-year patient-reported outcome measures (PROMs) were completed: EuroQol five-dimension three-level questionnaire (EQ-5D-3L), OKS, pain, and satisfaction. Using national life expectancy data with obesity correction and the 2020 NHS National Tariff, QALYs (discounted at 3.5%), and direct medical costs accrued over a patient’s lifetime, were calculated. Probabilistic sensitivity analysis (PSA) was used to model variation in cost/QALY for each cohort across 1,000 simulations.Aims
Methods
Long-term outcomes following the use of human dermal allografts in the treatment of symptomatic irreparable rotator cuff tears are not known. The aim of this study was to evaluate these outcomes, and to investigate whether this would be a good form of treatment in young patients in whom a reverse shoulder arthroplasty should ideally be avoided. This prospective study included 47 shoulders in 45 patients who underwent an open reconstruction of the rotator cuff using an interposition GraftJacket allograft to bridge irreparable cuff tears, between January 2007 and November 2011. The Oxford Shoulder Score (OSS), pain score, and range of motion (ROM) were recorded preoperatively and at one year and a mean of 9.1 years (7.0 to 12.5) postoperatively.Aims
Methods
After failed acetabular fractures, total hip arthroplasty (THA) is a challenging procedure and considered the gold standard treatment. The complexity of the procedure depends on the fracture pattern and the initial fracture management. This study’s primary aim was to evaluate patient-reported outcome measures (PROMs) for patients who underwent delayed uncemented acetabular THA after acetabular fractures. The secondary aims were to assess the radiological outcome and the incidence of the associated complications in those patients. A total of 40 patients underwent cementless acetabular THA following failed treatment of acetabular fractures. The postoperative clinical and radiological outcomes were evaluated for all the cohort.Aims
Methods
The COVID-19 pandemic drastically affected elective orthopaedic services globally as routine orthopaedic activity was largely halted to combat this global threat. Our institution (University College London Hospital, UK) previously showed that during the first peak, a large proportion of patients were hesitant to be listed for their elective lower limb procedure. The aim of this study is to assess if there is a patient perception change towards having elective surgery now that we have passed the peak of the second wave of the pandemic. This is a prospective study of 100 patients who were on the waiting list of a single surgeon for an elective hip or knee procedure. Baseline characteristics including age, American Society of Anesthesiologists (ASA) grade, COVID-19 risk, procedure type, and admission type were recorded. The primary outcome was patient consent to continue with their scheduled surgical procedure. Subgroup analysis was also conducted to define if any specific patient factors influenced decision to continue with surgeryAims
Methods
Outcomes following different types of surgical intervention for femoroacetabular impingement (FAI) are well reported individually but comparative data are deficient. The purpose of this study was to conduct a systematic review (SR) and meta-analysis to analyze the outcomes following surgical management of FAI by hip arthroscopy (HA), anterior mini open approach (AMO), and surgical hip dislocation (SHD). This SR was registered with PROSPERO. An electronic database search of PubMed, Medline, and EMBASE for English and German language articles over the last 20 years was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We specifically analyzed and compared changes in patient-reported outcome measures (PROMs), α-angle, rate of complications, rate of revision, and conversion to total hip arthroplasty (THA). A total of 48 articles were included for final analysis with a total of 4,384 hips in 4,094 patients. All subgroups showed a significant correction in mean α angle postoperatively with a mean change of 28.8° (95% confidence interval (CI) 21 to 36.5; p < 0.01) after AMO, 21.1° (95% CI 15.1 to 27; p < 0.01) after SHD, and 20.5° (95% CI 16.1 to 24.8; p < 0.01) after HA. The AMO group showed a significantly higher increase in PROMs (3.7; 95% CI 3.2 to 4.2; p < 0.01) versus arthroscopy (2.5; 95% CI 2.3 to 2.8; p < 0.01) and SHD (2.4; 95% CI 1.5 to 3.3; p < 0.01). However, the rate of complications following AMO was significantly higher than HA and SHD. All three surgical approaches offered significant improvements in PROMs and radiological correction of cam deformities. All three groups showed similar rates of revision procedures but SHD had the highest rate of conversion to a THA. Revision rates were similar for all three revision procedures.
Periacetabular osteotomy (PAO) is an established treatment for acetabular dysplasia. It has also been proposed as a treatment for patients with acetabular retroversion. By reviewing a large cohort, we aimed to test whether outcome is equivalent for both types of morphology and identify factors that influenced outcome. A single-centre, retrospective cohort study was performed on patients with acetabular retroversion treated with PAO (n = 62 hips). Acetabular retroversion was diagnosed clinically and radiologically (presence of a crossover sign, posterior wall sign, lateral centre-edge angle (LCEA) between 20° and 35°). Outcomes were compared with a control group of patients undergoing PAO for dysplasia (LCEA < 20°; n = 86 hips). Femoral version was recorded. Patient-reported outcome measures (PROMs), complications, and reoperation rates were measured.Aims
Methods
Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a
A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.Aims
Methods