Plain English Summary
Background and study aims
Slipped Capital Femoral Epiphysis (SCFE) is hip condition that occurs during childhood. It occurs when the ball at the head of the femur (thighbone) slipping off the neck of the bone in a backwards direction, causing pain, stiffness and instability in the affected hip. Perthes' disease is another childhood disorder which affects the ball at the head of the femur. In Perthes’ disease, the blood supply to the growth plate at the end of the femur becomes inadequate, causing the bone to break down (degeneration). Both of these conditions often require surgical treatment, and both are common causes of early osteoarthritis (a common form of arthritis) of the hip in adulthood. There is no good evidence to determine what causes either Perthes' Disease or SCFE, or what the best treatments are. The choice of treatment of either disease is dependent on the beliefs of the treating surgeon, rather than scientific evidence. In addition, the rareness of the diseases, and the emergency nature of surgery in SCFE are slowing down progress. This study aims to collect nationwide data about these two conditions in order to establish how common the diseases are, risk factors and different treatment options in order to improve future treatment and management options.
Who can participate?
Individuals with SCFE or Perthes’ disease
What does the study involve?
In the first part of the study, each participating centre is asked to enter anonymised case details into a central database of all cases of Perthes’ disease and SCFE that they treat at their centres. This allows the study team to determine how common each of the diseases are and what the different treatment strategies are across the UK. Further information is added after three months and two years for patients with SCFE and after one and two years for patients with Perthes’ disease.
In the second part of the study, a subset of patients agree to take part and complete questionnaire after three months and two years for patients with SCFE and after one and two years for patients with Perthes’ disease about their quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Alder Hey Children's NHS Foundation Trust and 143 other NHS Trusts across England, Scotland and Wales (UK)
When is the study starting and how long is it expected to run for?
January 2016 to September 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Mr Daniel Perry (scientific)
danperry@liv.ac.uk
2. Dr Emma Cwiklinski (public)
BOSS@liv.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Daniel Perry
ORCID ID
Contact details
Alder Hey Children's Hospital
East Prescot Road
Liverpool
L14 5AB
United Kingdom
+44 7815 122361
danperry@liv.ac.uk
Type
Public
Additional contact
Dr Emma Cwiklinski
ORCID ID
Contact details
Medicines for Children Clinical Trials Unit
Clinical Trials Research Centre
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP
United Kingdom
+44 151 794 9772
BOSS@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UoL001157
Study information
Scientific title
Investigating childhood hip diseases (Slipped capital femoral epiphysis and Perthes’ disease) as childhood precursors to osteoarthritis of the hip in adulthood: A nationwide anonymised surveillance cohort, and nested-consented cohort study
Acronym
BOSS
Study hypothesis
The aim of this study is to conduct a nationwide cohort of SCFE and Perthes’ disease to determine the disease incidence, case mix, risk factors, variations in surgical interventions, and to determine the safety and efficacy of different surgical strategies.
Ethics approval
East London and The City Research Ethics Committee, 20/01/2016, ref: 190754
Study design
Nationwide observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
1. Slipped Capital Femoral Epiphysis (SCFE)
2. Perthes' disease
Intervention
Surveillance Cohort Study
A consecutive anonymised comprehensive surveillance cohort encompassing all UK cases of SCFE and Perthes’ disease. Each participating centre is asked to enter anonymised case details into a central database of all cases of Perthes’ disease and SCFE that they treat at their centres. This will allow the study team to determine incidence of the diseases and what the different treatment strategies are across the UK. Individual patient consent is not required for this part of the study, with minimal identifiers collected to protect confidentiality. After inclusion into the study, follow-up is recorded using routine medical records at the following intervals: SCFE - 3 months and 2 years, Perthes' - 1 and 2 years.
Nested consented cohort
A subset of the surveillance cohort in designated centres will be invited to participate in a consented sub-study. In this sub-study, patients provide consent to collect patient reported outcomes at admission, 3 months and 2 years (SCFE) and, diagnosis, 1 year and 2 years (Perthes’). Participants also have the option to consent to long-term follow-up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Anonymised Surveillance Cohort:
Incidence of each disease within the UK is determined by expressing the cases seen as a proportion of the ‘at risk’ population. The ‘at risk’ population will be derived from government statistics. In order to ensure that the data collection mechanism is sensitive, a national independent network of orthopaedic surgical trainees (the BONE collaborative), and national routine administrative data provided by HSCIC is used to identify missing cases, and prompt their imputation into the cohort.
Nested Consented Cohort
Quality of Life is measured using the Pediatric Quality of Life Inventory (PEDSQL) at baseline, 3 months (SCFE only), 1 year (Perthes’ disease only) and 2 years (both diseases).
Secondary outcome measures
Anonymised Surveillance Cohort:
SCFE
1. Radiographic Severity (Alpha angle) is assessed by reviewing radiographs that form part of the routine medical record at 2 years
2. Frequency of Avascular Necrosis is assessed by review of routine medical records at 3 months and 2 years, and by reviewing radiographs that form part of the routine medical record at 2 years
3. Frequency of Contralateral slip is assessed by review of routine medical records at 3 months and 2 years, and by reviewing radiographs that form part of the routine medical record at 2 years
4. Frequency of Chondrolysis is assessed by review of routine medical records at 3 months and 2 years, and by reviewing radiographs that form part of the routine medical record at 2 years
Perthes' Disease
1. Radiographic Outcome (Stulberg Outcome) is assessed by review of routine medical records at 2 years, and by reviewing radiographs that form part of the routine medical record at 2 years
2. Frequency of contralateral disease is assessed by rview of routine medical records at 2 years, and by reviewing radiographs that form part of the routine medical record at 2 years
Nested Consented Cohort
Both Diseases (2 years)
1. Pain is measured using the Wong-Baker Faces Pain Score at baseline, 3 months (SCFE only), 1 year (Perthes’ disease only) and 2 years (both diseases)
2. Quality of life is measured using the EQ5DY questionnaire at baseline, 3 months (SCFE only), 1 year (Perthes’ disease only) and 2 years (both diseases)
Overall trial start date
01/03/2015
Overall trial end date
01/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
SCFE:
1.Skeletally immature individuals
2. Radiological confirmation of displacement of the epiphysis relative to the metaphysis occurring at the proximal femoral physis
3. Newly presenting to secondary/ tertiary care during the study period with the above radiographic changes in either hip (i.e. patients will be included if the other side has been affected outside the study period, but the opposite hip is newly affected)
4. Undergoing surgical stabilisation during hospital admission
5. Resident within the England, Scotland or Wales
Perthes:
1. Skeletally immature individuals.
2. Any of the following radiographic features within the femoral epiphysis. Features may be evident on plain radiographs, or MRI.
2.1. Flattening
2.2. Sclerosis
2.3. Fragmentation
2.4. Collapse
2.5. Reossification
3. Newly presenting to secondary/ tertiary care during the study period with the above radiographic changes in either hip (i.e. patients will be included if the other side has been affected outside the study period, but the opposite hip is newly affected)
4. Usually resident within the England, Scotland or Wales
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
The surveillance cohort will recruit for a period of 1 year (of full centre engagement) to determine incidence of the diseases under study. The nested consented cohort will require 300 cases of each disease to enable meaningful comparisons to be made within subgroups.
Participant exclusion criteria
SCFE:
Previous attempts at stabilisation of the currently affected hip.
Perthes:
1. Previous treatment for developmental hip dysplasia (not including double nappies)
2. Previous chemotherapy for malignancy
3. Previously diagnosed sickle cell anaemia
4. Multiple Epiphyseal Dysplasia (MED) or Spondyloepiphyseal Dysplasia (SED).
5. A known coagulopathy
6. Gauchers disease
7. Previous same-sided hip fracture
8. Hypothyroidism
Recruitment start date
04/04/2016
Recruitment end date
30/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L14 5AB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Patients and public:
Material for dissemination will be developed in conjunction with the patient panel, the NIHR CRN: Children ‘Young Peoples Advisory Group’ and STEPS and the Perthes’ Association; UK charities. STEPS and the Perthes’ Association have agreed to communicate the outcomes of the research via their newsletter, website and information packages. For the wider public it is planned that the INVOLVE national advisory group will be an important liaison throughout, with dissemination adhering to the ‘make it clear’ guidance. Following the recommendations of the 2013 ‘GenerationR’ report, written feedback will be offered to study participants, which is produced in accordance with the advisory groups (above). This will enable participants to gain appreciation of the contribution they have made to the research, and how this has positively influenced the care of others.
Specialists & Generalists:
Early in the study the detailed protocol will be published in an open access journal to make it widely accessible to the medical community. Each annual meeting of the British Society of Children’s Orthopaedic Surgery (BSCOS) will contain a breakout meeting to engage with the UK orthopaedic community regarding study recruitment. On completion of the study, results will be formally presented to BSCOS and the British Orthopaedic Association (BOA). Results will be written for high impact journals, to target the both the specialist audience, and the generalist.
Policy makers:
NICE have issued recommendations for a study of this nature, and have emphasised their support for this study. The results will therefore have immediate impact on SCFE care through the development of NICE recommendations, made in conjunction with the specialist societies (BOA & BSCOS).
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from danperry@liverpool.ac.uk
Intention to publish date
31/12/2020
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list