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The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1088 - 1095
1 Jun 2021
Banger M Doonan J Rowe P Jones B MacLean A Blyth MJB

Aims. Unicompartmental knee arthroplasty (UKA) is a bone-preserving treatment option for osteoarthritis localized to a single compartment in the knee. The success of the procedure is sensitive to patient selection and alignment errors. Robotic arm-assisted UKA provides technological assistance to intraoperative bony resection accuracy, which is thought to improve ligament balancing. This paper presents the five-year outcomes of a comparison between manual and robotically assisted UKAs. Methods. The trial design was a prospective, randomized, parallel, single-centre study comparing surgical alignment in patients undergoing UKA for the treatment of medial compartment osteoarthritis (ISRCTN77119437). Participants underwent surgery using either robotic arm-assisted surgery or conventional manual instrumentation. The primary outcome measure (surgical accuracy) has previously been reported, and, along with secondary outcomes, were collected at one-, two-, and five-year timepoints. Analysis of five-year results and longitudinal analysis for all timepoints was performed to compare the two groups. Results. Overall, 104 (80%) patients of the original 130 who received surgery were available at five years (55 robotic, 49 manual). Both procedures reported successful results over all outcomes. At five years, there were no statistical differences between the groups in any of the patient reported or clinical outcomes. There was a lower reintervention rate in the robotic arm-assisted group with 0% requiring further surgery compared with six (9%) of the manual group requiring additional surgical intervention (p < 0.001). Conclusion. This study has shown excellent clinical outcomes in both groups with no statistical or clinical differences in the patient-reported outcome measures. The notable difference was the lower reintervention rate at five years for roboticarm-assisted UKA when compared with a manual approach. Cite this article: Bone Joint J 2021;103-B(6):1088–1095


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1408 - 1415
1 Dec 2024
Wall L Bunzli S Nelson E Hawke LJ Genie M Hinwood M Lang D Dowsey MM Clarke P Choong PF Balogh ZJ Lohmander LS Paolucci F

Aims

Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments.

Methods

This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1052 - 1059
1 Oct 2023
El-Sahoury JAN Kjærgaard K Ovesen O Hofbauer C Overgaard S Ding M

Aims

The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Methods

A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 319 - 322
1 Apr 2024
Parsons N Whitehouse MR Costa ML


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 833 - 836
1 Aug 2023
Mancino F Gant V Meek DRM Haddad FS


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 764 - 774
1 Aug 2024
Rivera RJ Karasavvidis T Pagan C Haffner R Ast MP Vigdorchik JM Debbi EM

Aims

Conventional patient-reported surveys, used for patients undergoing total hip arthroplasty (THA), are limited by subjectivity and recall bias. Objective functional evaluation, such as gait analysis, to delineate a patient’s functional capacity and customize surgical interventions, may address these shortcomings. This systematic review endeavours to investigate the application of objective functional assessments in appraising individuals undergoing THA.

Methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were applied. Eligible studies of THA patients that conducted at least one type of objective functional assessment both pre- and postoperatively were identified through Embase, Medline/PubMed, and Cochrane Central database-searching from inception to 15 September 2023. The assessments included were subgrouped for analysis: gait analysis, motion analysis, wearables, and strength tests.


Aims

The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial.

Methods

This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1070 - 1077
1 Oct 2023
Png ME Costa M Nickil A Achten J Peckham N Reed MR

Aims

To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults.

Methods

Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

Methods

This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 450 - 459
1 May 2024
Clement ND Galloway S Baron J Smith K Weir DJ Deehan DJ

Aims

The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA).

Methods

A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1133 - 1134
1 Nov 2023
Haddad FS

Cite this article: Bone Joint J 2023;105-B(11):1133–1134.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 642 - 645
1 Jul 2024
Harris IA Sidhu VS MacDessi SJ Solomon M Haddad FS


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 795 - 800
1 Jul 2023
Parsons N Achten J Costa ML

Aims

To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial.

Methods

The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded.


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1132 - 1141
1 Oct 2022
Holm-Glad T Røkkum M Röhrl SM Roness S Godang K Reigstad O

Aims

To analyze the short-term outcome of two types of total wrist arthroplasty (TWA) in terms of wrist function, migration, and periprosthetic bone behaviour.

Methods

A total of 40 patients suffering from non-rheumatoid wrist arthritis were enrolled in a randomized controlled trial comparing the ReMotion and Motec TWAs. Patient-rated and functional outcomes, radiological changes, blood metal ion levels, migration measured by model-based radiostereometric analysis (RSA), bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), complications, loosening, and revision rates at two years were compared.


Aims

The aim of this study was to compare any differences in the primary outcome (biphasic flexion knee moment during gait) of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) at one year post-surgery.

Methods

A total of 76 patients (34 bi-UKA and 42 TKA patients) were analyzed in a prospective, single-centre, randomized controlled trial. Flat ground shod gait analysis was performed preoperatively and one year postoperatively. Knee flexion moment was calculated from motion capture markers and force plates. The same setup determined proprioception outcomes during a joint position sense test and one-leg standing. Surgery allocation, surgeon, and secondary outcomes were analyzed for prediction of the primary outcome from a binary regression model.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1595 - 1603
1 Oct 2021
Magill P Hill JC Bryce L Martin U Dorman A Hogg R Campbell C Gardner E McFarland M Bell J Benson G Beverland D

Aims

In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss.

Methods

TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1176 - 1186
1 Jul 2021
Welford P Jones CS Davies G Kunutsor SK Costa ML Sayers A Whitehouse MR

Aims

The aim of this study was to assess the effect of time to surgical intervention from admission on mortality and morbidity for patients with hip fractures.

Methods

MEDLINE and Embase were searched from inception to June 2020. Reference lists were manually assessed to identify additional papers. Primary comparative research studies that recruited patients aged over 60 years, with non-pathological primary proximal femoral fractures that were treated surgically, were included. Studies that did not include a group operated on within 24 hours or which reported time to surgery in calendar days were excluded. Two investigators extracted data on study characteristics, methods, and outcomes. The pre-defined primary outcome was 30-day mortality. Secondary outcomes were complications and mortality at other time points. Relative risks (RRs) with 95% confidence intervals (CIs) were aggregated and were grouped by study-level characteristics.


Aims

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.


Aims

This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.

Methods

The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.