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Bone & Joint Open
Vol. 6, Issue 3 | Pages 336 - 341
13 Mar 2025
Feng T Ablett A Scott CEH Clement ND

Aims. This study investigates the effectiveness and adequacy of the informed consent process for patients undergoing hip fracture surgery. While informed consent is a legal and ethical responsibility, factors in the trauma setting can impair patients’ understanding and retention of information. This study seeks to evaluate patients’ recall of perioperative complications and explore their perceptions of the consent process. Methods. A mixed-methods, multicentre cohort study will be conducted in the Southeast of Scotland. Adult patients with hip fractures will be recruited via consecutive sampling. An information recall questionnaire will be administered within 36 hours of admission to assess unprompted and prompted recall of complications. A subset of participants will then undergo a semi-structured qualitative interview postoperatively to explore their experiences and perceptions of the consent process. Data will be analyzed using a social constructivist grounded theory to assess their perceptions of consent. Ethical approval has been granted by the East of England Research Ethics Committee (reference 23/EE/0233). Conclusion. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. The study results will identify challenges in the consent process, particularly in how risks are communicated and understood. The data are expected to inform the development of information aids and enhance the ability of orthopaedic surgeons to provide comprehensive, patient-centred consent. Cite this article: Bone Jt Open 2025;6(3):336–341


Bone & Joint Open
Vol. 6, Issue 3 | Pages 291 - 297
7 Mar 2025
Zambito K Kushchayeva Y Bush A Pisani P Kushchayeva S Peters M Birch N

Aims. Assessment of bone health is a multifaceted clinical process, incorporating biochemical and diagnostic tests that should be accurate and reproducible. Dual-energy X-ray absorptiometry (DXA) is the reference standard for evaluation of bone mineral density, but has known limitations. Alternatives include quantitative CT (q-CT), MRI, and peripheral quantitative ultrasound (QUS). Radiofrequency echographic multispectrometry (REMS) is a new generation of ultrasound technology used for the assessment of bone mineral density (BMD) at axial sites that is as accurate as quality-assured DXA scans. It also provides an assessment of the quality of bone architecture. This will be of direct value and significance to orthopaedic surgeons when planning surgical procedures, including fracture fixation and surgery of the hip and spine, since BMD alone is a poor predictor of fracture risk. Methods. The various other fixed-site technologies such as high-resolution peripheral q-CT (HR-pQCT) and MRI offer no further significant prognostic advantages in terms of assessing bone structure and BMD to predict fracture risk. QUS was the only widely adopted non-fixed imaging option for bone health assessment, but it is not considered adequately accurate to provide a quantitative assessment of BMD or provide a prediction of fracture risk. In contrast, REMS has a robust evidence base that demonstrates its equivalence to DXA in determining BMD at axial sites. Fracture prediction using REMS, combining the output of fragility information and BMD, has been established as more accurate than when using BMD alone. Conclusion. The practice parameters described in this protocol provide a framework for clinicians who provide REMS services that will, to the greatest possible extent, ensure the most accurate assessment possible from this diagnostic technology. Cite this article: Bone Jt Open 2025;6(3):291–297


Bone & Joint Open
Vol. 4, Issue 10 | Pages 782 - 790
18 Oct 2023
Hamilton DF Gaston P Macpherson GJ Simpson P Clement ND

Aims. The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. Methods. A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m. 2. , or THA performed for pain relief in those with severely restricted mobility. Results. Implant survival, complications, functional outcomes and radiological assessment up to ten years following index THA (one, two, five, seven, and ten years) will be performed. Functional assessment will include the Oxford Hip Score, Forgotten Joint Score, 12-Item Short Form Health Survey, EuroQol five-dimension health questionnaire, and pain and patient satisfaction. Radiological assessment with assess for acetabula lucent lines, lysis, and loosening according to DeLee and Charnley zones. Conclusion. This study is part of a stepwise introduction of a new device to orthopaedic practice, and careful monitoring of implants should be carried out as part of the Beyond Compliance principles. The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential limitations of this new implant before wide adoption. Cite this article: Bone Jt Open 2023;4(10):782–790


Bone & Joint Open
Vol. 6, Issue 2 | Pages 164 - 177
10 Feb 2025
Clement ND Scott CEH Macpherson GJ Simpson PM Leitch G Patton JT

Aims

Unicompartmental knee arthroplasty (UKA) is associated with an accelerated recovery, improved functional outcomes, and retention of anatomical knee kinematics when compared to manual total knee arthroplasty (mTKA). UKA is not universally employed by all surgeons as there is a higher revision risk when compared to mTKA. Robotic arm-assisted (ra) UKA enables the surgeon to position the prosthesis more accurately when compared to manual UKA, and is associated with improved functional outcomes and a lower early revision risk. Non-randomized data suggests that, when compared to mTKA, raUKA has a clinically meaningful greater functional benefit. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of raUKA compared to mTKA for individuals with isolated medial compartment osteoarthritis (OA).

Methods

The total versus robotic-assisted unicompartmental knee arthroplasty (TRAKER) trial is a patient- and assessor-blinded, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary knee arthroplasty for primary medial compartment OA at a single NHS hospital (ClinicalTrials.gov NCT05290818). Participants will be randomly allocated on a 1:2 basis to either raUKA or mTKA, respectively. The primary analysis will compare the Oxford Knee Score (OKS) six months after surgery. Secondary outcomes measured at three, six, and 12 months include the OKS, Forgotten Joint Score, patient expectations, EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (EQ-VAS), patient satisfaction, range of motion, postoperative complications, need for further surgery, resource use, and financial costs. Cost-effectiveness will be measured over a ten-year time span. A total of 159 patients will be randomized (n = 53 raUKA vs n = 106 mTKA) to obtain 80% power to detect a five-point difference in OKS between the groups six months after surgery.


Bone & Joint Open
Vol. 6, Issue 1 | Pages 21 - 25
4 Jan 2025
Craven J O’Malley O Perry DC

Aims

This study aims to define a set of family-centred core outcomes for infants undergoing brace treatment to facilitate consistent reporting for future high-quality research.

Methods

Family-centred outcomes will be identified through a literature review and a scoping survey involving key stakeholders, including parents, healthcare professionals, and researchers. These outcomes will then be rated for their perceived importance in a two-stage modified Delphi process with the same stakeholders. Finally, a consensus meeting will be held to establish the final core outcome set (COS).


Bone & Joint Open
Vol. 3, Issue 7 | Pages 529 - 535
1 Jul 2022
Wormald JCR Rodrigues JN Cook JA Prieto-Alhambra D Costa ML

Aims

Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial.

Methods

A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work.


Bone & Joint Open
Vol. 3, Issue 1 | Pages 54 - 60
14 Jan 2022
Leo DG Green G Eastwood DM Bridgens A Gelfer Y

Aims

The aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD).

Methods

Relevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families.