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Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Methods

The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 28 - 28
7 Aug 2023
Bertram W Wylde V Glynn J Penfold C Burston A Johnson E Rayment D Howells N White S Gooberman-Hill R Whale K
Full Access

Abstract

Introduction

There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR.

Methodology

REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 41 - 41
1 Feb 2020
Melnic C Aurigemma P Dwyer M Domingo-Johnson E Bedair H
Full Access

Background

Multiple retrospective studies have compared UC with traditional bearings and shown comparable results and outcomes when looking at clinical and radiologic variables, complications rates, and implant survivorship; however, debate still exists regarding the optimum bearing surface. The present study seeks to determine whether there are any preoperative patient demographic or medical factors or anatomic variables including femoral condylar offset and tibial slope that may predict use of a UC bearing when compared to a standard CR group.

Methods

The study cohort consisted of 117 patients (41 males, 76 females) who underwent primary TKA with the senior author. The implants utilized were either the CR or UC polyethylene components of the Zimmer Persona Total Knee System. Insert selection was based on intraoperative assessment of PCL integrity and soft tissue balancing. Patient demographics (age, gender, BMI) and co-morbidities (hypertension, diabetes, depression, cardiac disease, and lung disease) were recorded. Intraoperative variables of interest included extension and flexion range of motion, estimated blood loss (EBL), tourniquet time, and polyethylene and femoral component sizes. We calculated change in tibial slope and femoral condylar offset from pre- to post-surgery and computed the percentage of patients for whom an increase in tibial slope or femoral condylar offset was determined. Postoperative variables, including length of stay, complication rates and reoperation rates, were recorded. All dependent variables were compared between patients who received the UC component and patients who received the CR component. Continuous variables were assessed using independent samples t-tests, while categorical variables were compared using the chi-square test of independence.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 42 - 42
1 May 2017
Malahais MA Babis G Johnson E Kaseta M Chytas D Nikolaou V
Full Access

Background

To investigate the new theory of hydroneurolysis and hydrodissection in the treatment of carpal tunnel syndrome (CTS). Independently of the fluid hydrodissolution works due to mechanical forces and it may have some positive effects in patients with ischemic damage caused by scar tissue pressure at the nerve's surface.

Methods

A prospective blind clinical study of 31 patients suffering from carpal tunnel syndrome, established by nerve conduction studies and clinical tests. 14 patients (out of 29), who refused to undergo an open operation as a treatment to their disease at this point of time, were treated with a simple ultrasound-guided injection at the proximal carpal tunnel. In order to exclude the biochemical influence of the fluid in the treating disease we choosed to infiltrate 3 cc. of normal saline 0,9%. In the follow-up period our group was asked to answer to a new Q-DASH score and visual analogue scale (VAS) 100/100 in 2, 4 and 8 weeks.


Summary

The findings demonstrate that culture expanded human mesenchymal stem cells (MSCs) incorporated and proliferated in clinically relevant cell scaffolds better than freshly isolated bone marrow mononucleated cells (MNCs); in fact, only in MSC cultures were cells present for longer term chondrogenic inductions.

Introduction

The treatment of chondral defects poses a significant clinical problem and a variety of cell sources and techniques have been studied and practiced to regenerate cartilage. Preclinical and clinical evidence suggests that MSCs can help regenerate cartilage when transplanted into cartilage lesions. However, the uptake of MSCs for cell therapies is limited due to the need for their culture expansion to generate subsequent numbers for transplantation. An alternative is to use minimally manipulated MNCs, which avoids the costs and regulatory implications of culture expansion and would enable the treatment of cartilage defects in a one-step procedure. Therefore, this study has focused on comparing these two cell types within three different scaffolds that can currently be used as cell delivery systems.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 230 - 230
1 Mar 2010
Stephan S Johnson E Roberts S
Full Access

Background: Degeneration of the intervertebral disc is associated with back pain. Cell transplantation to enhance disc regeneration is an attractive concept and clinical trials using autologous disc cells have begun. However, the capacity of the disc, which is poorly supplied by blood vessels, to support viable cells is currently unclear. In this study, we have assessed cell seeding densities and nutrition required to optimise nucleus pulposus (NP) cell survival and proliferation.

Methods: NP cells were cultured in alginate beads at cell seeding densities 1.25×105 – 1.0×106 cells/ml, either in 10% or 20% serum (vol/vol) ± glucose for 8 days. Cell proliferation was measured by immunopositivity for a proliferation marker, the Ki67 antigen. Cell viability was assessed by DAPI staining.

Results: NP cells grown in 10% serum with glucose proliferated and formed cell clusters at low cell seeding densities; however, this proliferative response was significantly decreased at the higher cell seeding densities. Increasing serum from 10% to 20% markedly increased the size of cell clusters that formed. Interestingly, cells grown in 20% serum but without glucose produced the largest cell clusters, some containing > 40 cells. However, DAPI staining revealed that many cells forming these clusters were dieing via apoptosis.

Conclusion: The manipulation of cells in culture, prior to transplantation into degenerate discs, may be key to optimising cell-mediated tissue regeneration. This study has shown that the number of cells transplanted and the level of nutrition available in the degenerate disc microenvironment may directly influence cell proliferation and survival potential and therefore their regenerative capability.