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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 328 - 335
12 Mar 2025
Logishetty K Verhaegen JCF Tse S Maheswaran T Fornasiero M Subbiah Ponniah H Hutt JB Witt JD

Aims. The effectiveness of total hip arthroplasty (THA) for patients with no or minimal radiological signs of osteoarthritis (OA) is unclear. In this study, we aimed to: 1) assess the outcome of such patients; 2) identify patient comorbidities and CT or MRI findings which predicted outcome; and 3) compare their outcome to the expected outcome of THA for hip OA. Methods. Adult patients undergoing THA for hip pain, with no or minimal radiological features of OA (Tönnis grading scale ≤ 1), were identified from a consecutive series of 1,925 THAs. Exclusion criteria were: inflammatory arthritis; osteonecrosis of the femoral head; prior trauma or infection; and patients without minimum one-year follow-up and patient-reported outcome measures (PROMs). The primary outcome measure was the Oxford Hip Score (OHS). Secondary outcome measures were EuroQol-visual analogue scale (EQ-VAS), University of California and Los Angeles (UCLA) scale, and patient satisfaction on a validated three-point ‘better’, ‘same’, or ‘worse’ scale. Results. A total of 107 patients with a median age of 41 years (IQR 18 to 73) were included, with mean follow-up of 6.0 years (SD 3.1). All patients underwent a diagnostic hip injection as a decision aid. Median postoperative OHS was 34 (IQR 28 to 42), with 36 patients (33%) achieving a patient-acceptable symptom state (OHS ≥ 42), lower than THA patients in international registries (40 to 43 points). Secondary outcomes were UCLA of 6 (4 to 8) and EQ-VAS of 73 (51 to 80); 91/102 patients (89%) felt ‘better’ and would ‘undergo surgery again'. Patients with chronic pain syndrome or hypermobility had lower OHS than patients without comorbidities (-6 points, p < 0.006). Overall, 84 patients had a CT and 34 patients an MRI. Patients with subchondral cysts (OHS 42 (37 to 45) vs 35 (26 to 36); p = 0.014) or joint space narrowing on CT (OHS 42 (IQR 37 to 44) vs 35 (26 to 36); p = 0.022) had higher function. Conclusion. Despite high satisfaction levels, patients undergoing THA with minimal or no radiological OA had lower postoperative function than typical THA patients. We recommend obtaining low-dose CT imaging and a diagnostic hip injection to aid decision-making. Cite this article: Bone Jt Open 2025;6(3):328–335


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.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 227 - 236
26 Feb 2025
de Haas LEM van de Lücht VAP van Hoorn BT Salentijn DA Groenwold RHH Schep NWL van Heijl M

Aims

To evaluate patient-reported outcomes three months after treatment of metacarpal and phalangeal fractures or dislocations, and to identify factors that are associated with worse patient-reported outcomes.

Methods

This cross-sectional, multicentre snapshot study included all adult patients with metacarpal and phalangeal fractures or dislocations during a three-month period between August and October 2020. The primary outcome was the Michigan Hand Outcomes Questionnaire (MHQ) three months after injury. The MHQ scores were compared to normative MHQ scores of 90 points of the affected hand of patients who sustained unilateral trauma derived from a previous study. Subgroup analyses were performed for the most common injury types. Multivariable linear regression was used to study associations between patient characteristics and worse MHQ scores.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 206 - 214
18 Feb 2025
Iken AR Gademan MGJ Snoeker BAM Vliet Vlieland TPM Poolman RW

Aims

To develop a multidisciplinary health research agenda (HRA) utilizing expertise from various disciplines to identify and prioritize evidence uncertainties in orthopaedics, thereby reducing research waste.

Methods

We employed a novel, structured framework to develop a HRA. We started by systematically collecting all evidence uncertainties from stakeholders with an interest in orthopaedic care, categorizing them into 13 sub-themes defined by the Dutch Orthopaedic Association (NOV). Subsequently, a modified two-phased Delphi study (two rounds per phase), adhering to the Conducting and REporting DElphi Studies (CREDES) guideline, was conducted. In Phase 1, board members assessed the collected evidence uncertainties on a three-point Likert scale to confirm knowledge gaps. In Phase 2, diverse stakeholders, including orthopaedic surgeons, rated the confirmed knowledge gaps on a seven-point Likert scale. Panel members rated one self-selected sub-theme and two randomly assigned sub-themes. The results from Phase 2 were ranked based on the overall average score for each uncertainty. Finally, a focus group discussion with patient associations’ representatives identified their top-ranked uncertainty from a predefined consensus process, leading to the final HRA. An advisory board, the Federation of Medical Specialists, and the NOV research coordinator oversaw the process.


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 2 | Pages 147 - 154
7 Feb 2025
Clement ND Qaddoura B Coppola A Akram N Pendyala S Jones S Afzal I Kader DF

Aims

Control of acute pain following knee arthroplasty (KA) with a perioperative peripheral nerve block (PNB) may improve functional outcomes and reduce the risk of chronic postoperative knee pain (CPKP). The aims of this study were to assess whether a PNB influences patient-reported outcomes and risk of CPKP at one year following KA.

Methods

A retrospective study was conducted over a two-year period and included 3,338 patients who underwent KA, of whom 1,434 (43.0%) had a lower limb PNB. A total of 2,588 patients (77.6%) completed and returned their one-year follow-up questionnaire. The Oxford Knee Score (OKS) and pain component (OKS-PS), EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (VAS) were collected preoperatively and at one year postoperatively. Patient satisfaction was also recorded at one year. The OKS-PS was used to define CPKP at one year.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 135 - 146
6 Feb 2025
Sherratt FC Swaby L Walker K Jayasuriya R Campbell L Mills AJ Gardner AC Perry DC Cole A Young B

Aims

The Bracing Adolescent Idiopathic Scoliosis (BASIS) study is a randomized controlled non-inferiority pragmatic trial of ‘full-time bracing’ (FTB) compared to ‘night-time bracing’ (NTB) for the treatment of adolescent idiopathic scoliosis (AIS). We anticipated that recruiting patients to BASIS would be challenging, as it is a paediatric trial comparing two markedly different bracing pathways. No previous studies have compared the experiences of AIS patients treated with FTB to those treated with NTB. This qualitative study was embedded in BASIS to explore families’ perspectives of BASIS, to inform trial communication, and to identify strategies to support patients treated in a brace.

Methods

Semi-structured interviews were conducted with parents (n = 26) and young people (n = 21) who had been invited to participate in BASIS at ten of the 22 UK paediatric spine services in hospitals recruiting to BASIS. Audio-recorded interviews were transcribed and analyzed thematically.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 126 - 134
4 Feb 2025
Schneller T Kraus M Schätz J Moroder P Scheibel M Lazaridou A

Aims. Machine learning (ML) holds significant promise in optimizing various aspects of total shoulder arthroplasty (TSA), potentially improving patient outcomes and enhancing surgical decision-making. The aim of this systematic review was to identify ML algorithms and evaluate their effectiveness, including those for predicting clinical outcomes and those used in image analysis. Methods. We searched the PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases for studies applying ML algorithms in TSA. The analysis focused on dataset characteristics, relevant subspecialties, specific ML algorithms used, and their performance outcomes. Results. Following the final screening process, 25 articles satisfied the eligibility criteria for our review. Of these, 60% focused on tabular data while the remaining 40% analyzed image data. Among them, 16 studies were dedicated to developing new models and nine used transfer learning to leverage existing pretrained models. Additionally, three of these models underwent external validation to confirm their reliability and effectiveness. Conclusion. ML algorithms used in TSA demonstrated fair to good performance, as evidenced by the reported metrics. Integrating these models into daily clinical practice could revolutionize TSA, enhancing both surgical precision and patient outcome predictions. Despite their potential, the lack of transparency and generalizability in many current models poses a significant challenge, limiting their clinical utility. Future research should prioritize addressing these limitations to truly propel the field forward and maximize the benefits of ML in enhancing patient care. Cite this article: Bone Jt Open 2025;6(2):126–134


Bone & Joint Open
Vol. 6, Issue 1 | Pages 26 - 34
6 Jan 2025
Findeisen S Mennerat L Ferbert T Helbig L Bewersdorf TN Großner T Schamberger C Schmidmaier G Tanner M

Aims. The aim of this study was to evaluate the radiological outcome of patients with large bone defects in the femur and tibia who were treated according to the guidelines of the diamond concept in our department (Centre for Orthopedics, Trauma Surgery, and Paraplegiology). Methods. The following retrospective, descriptive analysis consists of patients treated in our department between January 2010 and December 2021. In total, 628 patients were registered, of whom 108 presented with a large-sized defect (≥ 5 cm). A total of 70 patients met the inclusion criteria. The primary endpoint was radiological consolidation of nonunions after one and two years via a modified Lane-Sandhu Score, including only radiological parameters. Results. The mean defect size was 6.77 cm (SD 1.86), with the largest defect being 12.6 cm. Within two years after surgical treatment, 45 patients (64.3%) presented consolidation of the previous nonunion. After one year, six patients (8.6%) showed complete consolidation and 23 patients (32.9%) showed a considerable callus formation, whereas 41 patients (58.6%) showed a Lane-Sandhu score of 2 or below. Two years after surgery, 24 patients (34.3%) were categorized as Lane-Sandhu score 4, another 23 patients (32.9%) reached a score of 3, while 14 patients (20.0%) remained without final consolidation (score ≤ 2). A total of nine patients (12.9%) missed the two-year follow-up. The mean follow-up was 44.40 months (SD 32.00). The mean time period from nonunion surgery to consolidation was 16.42 months (SD 9.73). Conclusion. Patients with presentation of a large-sized nonunion require a structured and sufficiently long follow-up to secure the consolidation of the former nonunion. Furthermore, a follow-up of at least two years is required in order to declare a nonunion as consolidated, given that a significant part of the nonunions declared as not consolidated at one year showed consolidation within the second year. Moreover, the proven “gold standard” of a two-step procedure, so called Masquelet technique, shows effectiveness. Cite this article: Bone Jt Open 2024;6(1):26–34


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. 5, Issue 12 | Pages 1101 - 1107
11 Dec 2024
Haas-Lützenberger EM Emelianova I Bader MC Mert S Moellhoff N Demmer W Berger U Giunta R

Aims. In the treatment of basal thumb osteoarthritis (OA), intra-articular autologous fat transplantation has become of great interest within recent years as a minimally invasive and effective alternative to surgical intervention with regard to pain reduction. This study aims to assess its long-term effectiveness. Methods. Patients diagnosed with stage one to three OA received a single intra-articular autologous fat transplantation. Fat tissue was harvested from the abdomen and injected into the trapeziometacarpal (TMC) joint under radiological guidance, followed by one week of immobilization. Patients with a minimum three-year post-procedure period were assessed for pain level (numerical rating scale), quality of life (Mental Health Quotient (MHQ)), the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH)), and grip and pinch strength, as well as their overall impression of the treatment. Wilcoxon tests compared data from pre-intervention, and at one and three years post-intervention. Results. Out of 136 treated joints, the study involved 87 patients (37 patients were loss to follow-up, and 12 patients (9%) who underwent resection arthroplasty) with a median follow-up of 4.9 years (IQR 5.4 to 5.9). Pain, both at rest and during stress, significantly improved at one year and remained stable through three years. Sex, age, and stage of disease were not associated with postoperative pain levels. Patient-reported outcome measures for QuickDASH and MHQ improved up to at least three years post-treatment. Patients reported high satisfaction and willingness to recommend the procedure. Grip and pinch strength did not significantly change over time. Conclusion. The data show that autologous fat transfer has a longer-lasting effect in two-thirds of re-examined patients. If patients had an initial positive response, the pain-reducing effect lasted for at least three years. Therefore, this minimally invasive approach can offer a valuable treatment alternative for basal thumb OA


Aims

Functional alignment (FA) in total knee arthroplasty (TKA) aims to achieve balanced gaps by adjusting implant positioning while minimizing changes to constitutional joint line obliquity (JLO). Although FA uses kinematic alignment (KA) as a starting point, the final implant positions can vary significantly between these two approaches. This study used the Coronal Plane Alignment of the Knee (CPAK) classification to compare differences between KA and final FA positions.

Methods

A retrospective analysis compared pre-resection and post-implantation alignments in 2,116 robotic-assisted FA TKAs. The lateral distal femoral angle (LDFA) and medial proximal tibial angle (MPTA) were measured to determine the arithmetic hip-knee-ankle angle (aHKA = MPTA – LDFA), JLO (JLO = MPTA + LDFA), and CPAK type. The primary outcome was the proportion of knees that varied ≤ 2° for aHKA and ≤ 3° for JLO from their KA to FA positions, and direction and magnitude of those changes per CPAK phenotype. Secondary outcomes included proportion of knees that maintained their CPAK phenotype, and differences between sexes.


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1049 - 1066
1 Dec 2024
Lister J James S Sharma HK Hewitt C Fulbright H Leggett H McDaid C

Aims

Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients.

Methods

A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts.


Bone & Joint Open
Vol. 5, Issue 11 | Pages 962 - 970
4 Nov 2024
Suter C Mattila H Ibounig T Sumrein BO Launonen A Järvinen TLN Lähdeoja T Rämö L

Aims

Though most humeral shaft fractures heal nonoperatively, up to one-third may lead to nonunion with inferior outcomes. The Radiographic Union Score for HUmeral Fractures (RUSHU) was created to identify high-risk patients for nonunion. Our study evaluated the RUSHU’s prognostic performance at six and 12 weeks in discriminating nonunion within a significantly larger cohort than before.

Methods

Our study included 226 nonoperatively treated humeral shaft fractures. We evaluated the interobserver reliability and intraobserver reproducibility of RUSHU scoring using intraclass correlation coefficients (ICCs). Additionally, we determined the optimal cut-off thresholds for predicting nonunion using the receiver operating characteristic (ROC) method.


Bone & Joint Open
Vol. 5, Issue 11 | Pages 953 - 961
1 Nov 2024
Mew LE Heaslip V Immins T Ramasamy A Wainwright TW

Aims

The evidence base within trauma and orthopaedics has traditionally favoured quantitative research methodologies. Qualitative research can provide unique insights which illuminate patient experiences and perceptions of care. Qualitative methods reveal the subjective narratives of patients that are not captured by quantitative data, providing a more comprehensive understanding of patient-centred care. The aim of this study is to quantify the level of qualitative research within the orthopaedic literature.

Methods

A bibliometric search of journals’ online archives and multiple databases was undertaken in March 2024, to identify articles using qualitative research methods in the top 12 trauma and orthopaedic journals based on the 2023 impact factor and SCImago rating. The bibliometric search was conducted and reported in accordance with the preliminary guideline for reporting bibliometric reviews of the biomedical literature (BIBLIO).


Bone & Joint Open
Vol. 5, Issue 10 | Pages 929 - 936
22 Oct 2024
Gutierrez-Naranjo JM Salazar LM Kanawade VA Abdel Fatah EE Mahfouz M Brady NW Dutta AK

Aims

This study aims to describe a new method that may be used as a supplement to evaluate humeral rotational alignment during intramedullary nail (IMN) insertion using the profile of the perpendicular peak of the greater tuberosity and its relation to the transepicondylar axis. We called this angle the greater tuberosity version angle (GTVA).

Methods

This study analyzed 506 cadaveric humeri of adult patients. All humeri were CT scanned using 0.625 × 0.625 × 0.625 mm cubic voxels. The images acquired were used to generate 3D surface models of the humerus. Next, 3D landmarks were automatically calculated on each 3D bone using custom-written C++ software. The anatomical landmarks analyzed were the transepicondylar axis, the humerus anatomical axis, and the peak of the perpendicular axis of the greater tuberosity. Lastly, the angle between the transepicondylar axis and the greater tuberosity axis was calculated and defined as the GTVA.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 904 - 910
18 Oct 2024
Bergman EM Mulligan EP Patel RM Wells J

Aims

The Single Assessment Numerical Evalution (SANE) score is a pragmatic alternative to longer patient-reported outcome measures (PROMs). The purpose of this study was to investigate the concurrent validity of the SANE and hip-specific PROMs in a generalized population of patients with hip pain at a single timepoint upon initial visit with an orthopaedic surgeon who is a hip preservation specialist. We hypothesized that SANE would have a strong correlation with the 12-question International Hip Outcome Tool (iHOT)-12, the Hip Outcome Score (HOS), and the Hip disability and Osteoarthritis Outcome Score (HOOS), providing evidence for concurrent validity of the SANE and hip-specific outcome measures in patients with hip pain.

Methods

This study was a cross-sectional retrospective database analysis at a single timepoint. Data were collected from 2,782 patients at initial evaluation with a hip preservation specialist using the iHOT-12, HOS, HOOS, and SANE. Outcome scores were retrospectively analyzed using Pearson correlation coefficients.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 886 - 893
15 Oct 2024
Zhang C Li Y Wang G Sun J

Aims

A variety of surgical methods and strategies have been demonstrated for Andersson lesion (AL) therapy. In 2011, we proposed and identified the feasibility of stabilizing the spine without curettaging the vertebral or discovertebral lesion to cure non-kyphotic AL. Additionally, due to the excellent reunion ability of ankylosing spondylitis, we further came up with minimally invasive spinal surgery (MIS) to avoid the need for both bone graft and lesion curettage in AL surgery. However, there is a paucity of research into the comparison between open spinal fusion (OSF) and early MIS in the treatment of AL. The purpose of this study was to investigate and compare the clinical outcomes and radiological evaluation of our early MIS approach and OSF for AL.

Methods

A total of 39 patients diagnosed with AL who underwent surgery from January 2004 to December 2022 were retrospectively screened for eligibility. Patients with AL were divided into an MIS group and an OSF group. The primary outcomes were union of the lesion on radiograph and CT, as well as the visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores immediately after surgery, and at the follow-up (mean 29 months (standard error (SE) 9)). The secondary outcomes were total blood loss during surgery, operating time, and improvement in the radiological parameters: global and local kyphosis, sagittal vertical axis, sagittal alignment, and chin-brow vertical angle immediately after surgery and at the follow-up.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 729 - 735
3 Sep 2024
Charalambous CP Hirst JT Kwaees T Lane S Taylor C Solanki N Maley A Taylor R Howell L Nyangoma S Martin FL Khan M Choudhry MN Shetty V Malik RA

Aims. Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. Methods. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome. Cite this article: Bone Jt Open 2024;5(9):729–735