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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 3 - 3
10 Jun 2024
Alsousou J Keene D Harrison P O'Connor H Wagland S Dutton S Hulley P Lamb S Willett K
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Background

The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture.

Study design

Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 18 - 18
8 May 2024
Keene D Alsousou J Harrison P Hulley P Wagland S Parsons S Thompson J O'Connor H Schlüssel M Dutton S Lamb S Willett K
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Background

Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.

Methods

In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 57 - 57
2 May 2024
Martin A Alsousou J Chou D Costa M Carrothers A
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Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients.

This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures.

Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8.

This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options.


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. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims

To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.

Methods

A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.


Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing.

£250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics.

11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical equipoise was identified as an issue regarding recruitment. Full trial recruitment (60 patients) achieved; 333 patients screened. 66% male, median age 76 (range 63–93), median BMI 25 (range 18–37), 87% full mental capacity, 77% admitted from own home. 75% fall from standing height. 60% fractures; anterior column posterior hemi-transverse. Trial feasibility confirmed December 2020. Presented data- secondary outcomes that are statistically significant in improvement from baseline for only the fix and replace arm, with acceptable trial complications. Issues are highlighted with conservative management in this patient cohort.

Our unique RCT informs design and sample size calculation for a future RCT. It represents the first opportunity to understand the intricacies of these treatment modalities. This RCT provides clinicians with information on how best to provide management for this medically complex patient cohort.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1173 - 1173
1 Jun 2021
Alsousou J Oragui E Martin A Strickland L Newman S Kendrick B Taylor A Glyn-Jones S


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 644 - 649
1 Apr 2021
Alsousou J Oragu E Martin A Strickland L Newman S Kendrick B Taylor A Glyn-Jones S

Aims

The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA).

Methods

A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 11 - 11
1 Dec 2017
Kaye A Widnall J Redfern J Alsousou J Molloy A Mason L
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Background

There is an increasing acceptance that the clinical outcomes following posterior malleolar fractures are less than satisfactory. In our previous multicenter study (Powell, BOFAS 2016) we showed that the Olerud-Molander Ankle Score (OMAS) was 79 for unimalleolar fractures and 65 for bi malleolar fractures, however it dropped significantly to 54 in trimalleolar fractures. In creating a treatment guiding classification, we report our results in a system change in management of posterior malleolar fractures in our unit.

Method

All fractures were classified according to Mason and Molloy classification (BOFAS 2015, FAI 2017) based on CT scans obtained pre-operatively. This dictated the treatment algorithm. Type 1 fractures underwent syndesmotic fixation. Type 2A fractures underwent ORIF through a posterolateral incision, and type 2B and 3 fractures underwent ORIF through a posteromedial incision. The patient remained NWB for 6 weeks postoperative. Data was collected from December 2014 to July 2017.


The Bone & Joint Journal
Vol. 95-B, Issue 12 | Pages 1714 - 1720
1 Dec 2013
Hamilton TW Hutchings L Alsousou J Tutton E Hodson E Smith CH Wakefield J Gray B Symonds S Willett K

We investigated whether, in the management of stable paediatric fractures of the forearm, flexible casts that can be removed at home are as clinically effective, cost-effective and acceptable to both patient and parent as management using a cast conventionally removed in hospital. A single-centre randomised controlled trial was performed on 317 children with a mean age of 9.3 years (2 to 16). No significant differences were seen in the change in Childhood Health Assessment Questionnaire index score (p = 0.10) or EuroQol 5-Dimensions domain scores between the two groups one week after removal of the cast or the absolute scores at six months. There was a significantly lower overall median treatment cost in the group whose casts were removed at home (£150.88 (sem 1.90) vs £251.62 (sem 2.68); p <  0.001). No difference was seen in satisfaction between the two groups (p = 0.48).

Cite this article: Bone Joint J 2013;95-B:1714–20.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 178 - 178
1 Jan 2013
Alsousou J Franklin S Thompson M Harrison P Willett K
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Purpose

Platelet-Rich Plasma (PRP), an autologous derivative of whole blood that contains a supraphysiological concentration of platelets and growth factors. Most published studies have investigated the effect of PRP-conditioned media on cell cultures. We are not aware of any study that has investigated whole PRP with its cellular components on human tissue cultures. This study aims to investigate the effect of PRP on cell migration from human Achilles tendon explants, and the subsequent cellular proliferative effects in culture.

Methods

This is an in-vitro study on tendon explants obtained from Achilles tendon rupture patients. The samples were collected in sterile DMEM F12 solution then carefully cut into approximately 1–3mm3 sections. Tendon explants were cultured in three media types: 1. 100% PRP; 2. 50% PRP; and 3. 50% fetal calf serum (FCS). 1 and 2 were made up using DMEM F12 media (standard culture medium). Explants and cells were incubated at 37°c in 5% CO2 for 48 hours.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 6 - 6
1 Aug 2012
Alsousou J Handley R Hulley P Thompson M McNally E Harrison P Willett K
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Purpose

Platelet Rich Plasma (PRP) has been shown to have positive effect in tendon regeneration in in-vitro and limited in-vivo animal studies. We aim to study PRP use in acute Achilles tendon rupture (ATR) regeneration in a purposely designed clinical trial.

Methods

This is a prospective double-arm patient-blinded randomized controlled trial. ATR patients were randomized into PRP treatment or control groups. Non-operatively treated patients received PRP or control injection in clinic. In operatively treated patients, PRP gel was applied in the ruptured gap during percutaneous repair. Standard rehabilitation protocol was used and patients were followed up for 24 weeks. ATR, VISA-A and FAOS scores were used as subjective outcome measures. Functional ultrasound Elastography (FUSE) was performed at each follow-up to assess the mechanical properties of tendons. PRP analysis and tendon needle-biopsy were performed to study the histological differences during healing in both groups.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 94 - 94
1 May 2012
Alsousou J Butler D Bourma O Lecky F Willett K
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Introduction

It has been suggested that the transition phases of implementing daylight saving time (DST) may impact on serious or fatal injuries sustained as the result of road traffic collision (RTC). The aim of this study is to explore the effects of transitions into and out of daylight saving time on the incidence of such injuries.

Method

This is a retrospective comparative observational study of 11-year of data submitted prospectively to the Trauma Audit Research Network (TARN) between 1996 and 2006. Data for 4 weeks before and after time transition in spring and autumn of each year was collected. The time periods selected reflect those hours with maximum light level changes due to time alterations (2-hour around sunrise and 4-hour around sunset). Travellers outside those hours are unlikely to be affected by the changes.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 53 - 53
1 May 2012
Alsousou J Larry L McNally E Noble A Willett K
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Purpose

Functional ultrasound Elastography (FUSE) of Tendo Achilles is an ultrasound technique utilising controlled, measurable movement of the foot to non-invasively evaluate TA elastic and load-deformation properties. The study purpose is to assess Achilles tendons, paratenon and bursa mechanical properties in healthy volunteers and establish an outcome tool for TA treatment.

Methods

Forty asymptomatic Achilles tendons of 20 healthy volunteers were recruited (10 men and 10 women, age range 18-55). One patient with Acute Achilles rupture scanned to evaluate the tendon gap. Each volunteer answered the Foot and Ankle Outcome Score (FAOS) and Victorian Institute Sport Assessment score (VISA-A) questionnaires. The Achilles Tendons were divided into three thirds (total 120 Proximal, middle and distal thirds). Three longitudinal images of each third were obtained using portable US scan device (Z.one, Zonare Medical System Inc., USA, 8.5 MHz). Images processing was achieved using a MatLAb software (developed by the research team) in parallel Oxford university computers. Each 1/3rd Achilles tendon under went the following scans:

Free hand US scan

Free hand Compression decompression Elastography scan

Dorsal Flexion elastography

Planter flexion elastography

Zonare real-time Elastography

Elastography scan with the Oxford isometric dynamic foot and Ankle mover (OIDFA)

B mode and elasticity images were derived from the raw ultrasound radio frequency data. The anatomical structures mechanical properties were evaluated by a quantitative score of different colours representing stiff tissue (blue) to more soft tissue (green, yellow, red).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_II | Pages 40 - 40
1 Feb 2012
Alsousou J Sinha A McNally S
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We compared cancellation rates with two different systems for operating booking. During 9 months of ‘Full Booking’ we gave each patient in the Outpatient Clinic an operating date. After a transition period, we then tried ‘Partial Booking’ (putting each patient on the waiting list and only giving dates after a Consultant-delivered Pre-Assessment Clinic (PAC) review at least 6 weeks before their target operating date.)

This was one Consultant's firm, with Day Cases and urgent cases excluded, and a waiting time of nine months. Cancellations were defined as an operating date given that was not honoured. Cancellations due to bed crises were excluded.

During the Full Booking phase there was a cancellation rate of 55%, with 64 cancellations out of a potential 116 operating slots. Of these: 29% condition improved, 22% date inconvenient, 19% unwell, 5% gone elsewhere/Private, 9% were moved due to Consultant leave dates, 3% Did Not Attend, and 12.5% date brought forward to fill a cancellation slot.

During the Partial Booking phase, 23% of patients attending the PAC were removed from the waiting list without ever being given operating dates. (17 of 132 did not want the operation, 7 Did Not Attend, 6 were unfit). Of the 94 patients given dates, only 8 cancelled (8%). Four subsequently decided against surgery, and four had tests that suggested surgery would not be helpful.

The improved efficiency could be due to PAC changes: Consultant presence, having six weeks to act on test results, and dates being agreed only after ‘passing’ PAC. Partial Booking had other benefits, with fewer queries, better informed consent and the optimum time to plan teaching lists, order kit and improve patients' fitness. The Government is still committed to Full Booking. Our cancellation rate improved from 55% to 8% when changing from Full Booking to Partial Booking.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 309 - 309
1 Jul 2011
Alsousou J Jenks T Bouamra O Lecky F Willett K
Full Access

Background: It has been suggested that the transition phases of implementing daylight saving time (DST) may impact on serious or fatal injuries sustained as the result of road traffic collision (RTC). The aim of this study is to explore the effects of transitions into and out of daylight saving time on the incidence of such injuries.

Methods: This is a comparative observational study of 11-year of data submitted prospectively to the Trauma Audit Research Network (TARN) between 1996 and 2006. Data for 4 weeks before and after time transition in spring and autumn of each year was collected. The time periods selected reflect those hours with maximum light level changes due to time alterations (2-hour around sunrise and 4-hour around sunset). Travellers outside those hours are unlikely to be affected by the changes.

Results: Out of 55,826 incidents in England and Wales, TARN returned 1296 incidents meeting the above time criteria, of which 282 involved a fatality. Overall, there were more crashes in autumn (845, 65.2%) comparing to spring period (451, 34.8%), with the majority occurring around sunset (1057, 81.5%). RTC related injuries at the onset of DST in spring showed a significant increase up to 14 days post time change (P=0.029), with the majority of the increase occurring at sunset. The highest increases occurred within the fatal incidents group (P=0.0019) and affected mainly the pedestrian subgroup (P=0.013). Changes in the incidence of injuries around the change back to Greenwich Mean Time (GMT) in autumn did not reach significance.

Conclusion: The use of DST over the period studied was associated with rise in RTC related injury figures up to two weeks following the spring time transition. These findings inform the continuing clock changes debate. The introduction of 2-hour time change may result in detrimental effects on RTC related injuries.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 12 | Pages 1669 - 1677
1 Dec 2010
Thakar C Alsousou J Hamilton TW Willett K

We evaluated the cost and consequences of proximal femoral fractures requiring further surgery because of complications. The data were collected prospectively in a standard manner from all patients with a proximal femoral fracture presenting to the trauma unit at the John Radcliffe Hospital over a five-year period. The total cost of treatment for each patient was calculated by separating it into its various components. The risk factors for the complications that arose, the location of their discharge and the mortality rates for these patients were compared to those of a matched control group. There were 2360 proximal femoral fractures in 2257 patients, of which 144 (6.1%) required further surgery. The mean cost of treatment in patients with complications was £18 709 (£2606.30 to £60.827.10), compared with £8610 (£918.54 to £45 601.30) for uncomplicated cases (p < 0.01), with a mean length of stay of 62.8 (44.5 to 79.3) and 32.7 (23.8 to 35.0) days, respectively. The probability of mortality after one month in these cases was significantly higher than in the control group, with a mean survival of 209 days, compared with 496 days for the controls. Patients with complications were statistically less likely to return to their own home (p < 0.01).

Greater awareness and understanding are required to minimise the complications of proximal femoral fractures and consequently their cost.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 8 | Pages 987 - 996
1 Aug 2009
Alsousou J Thompson M Hulley P Noble A Willett K

Although mechanical stabilisation has been a hallmark of orthopaedic surgical management, orthobiologics are now playing an increasing role. Platelet-rich plasma (PRP) is a volume of plasma fraction of autologous blood having platelet concentrations above baseline. The platelet α granules are rich in growth factors that play an essential role in tissue healing, such as transforming growth factor-β, vascular endothelial growth factor, and platelet-derived growth factor. PRP is used in various surgical fields to enhance bone and soft-tissue healing by placing supraphysiological concentrations of autologous platelets at the site of tissue damage. The easily obtainable PRP and its possible beneficial outcome hold promise for new regenerative treatment approaches.

The aim of this literature review was to describe the bioactivities of PRP, to elucidate the different techniques for PRP preparation, to review animal and human studies, to evaluate the evidence regarding the use of PRP in trauma and orthopaedic surgery, to clarify risks, and to provide guidance for future research.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 4 | Pages 530 - 532
1 Apr 2009
Sen D Alsousou J Fraser J

We describe a technique to salvage a painful hemiarthroplasty due to erosion of the acetabular cartilage in the absence of loosening of the femoral component. A press-fit metallic acetabular component which matched the femoral component was used as a metal-on-metal articulation. The procedure offered a shorter operation time with less blood loss and no risk of femoral fracture as might have occurred during conventional revision to a total hip replacement. The patient made an unremarkable recovery with a good outcome at follow-up of 15 months.