British orthopaedic surgery surveillance study

ISRCTN	ISRCTN54477575
DOI	https://doi.org/10.1186/ISRCTN54477575
Protocol serial number	UoL001157
Sponsor	University of Liverpool
Funder	National Institute for Health Research

Submission date: 12/04/2017
Registration date: 19/04/2017
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
Prof Daniel Perry
D.C.Perry@liverpool.ac.uk

Contact information

Prof Daniel Perry
Scientific

Institute in the Park
Alder Hey Hospital
Liverpool
L12 2AP
United Kingdom

Phone	+44 7815 122361
Email	D.C.Perry@liverpool.ac.uk

Study information

Primary study design	Observational
Study design	Nationwide observational cohort study
Secondary study design	Cohort study
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
Study acronym	BOSS
Study objectives	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(s)	East London and The City Research Ethics Committee, 20/01/2016, ref: 190754
Health condition(s) or problem(s) studied	Slipped capital femoral epiphysis (SCFE), 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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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)
Completion date	01/03/2020

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	600
Total final enrolment	857
Key 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
Key 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
Date of first enrolment	04/04/2016
Date of final enrolment	30/09/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Alder Hey Children's NHS Foundation Trust

Eaton Road
Liverpool
L14 5AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Perthes' disease epidemiology and two-year outcomes	01/04/2022	04/04/2022	Yes	No
Results article	slipped capital femoral epiphysis epidemiology and two-year outcomes	01/04/2022	04/04/2022	Yes	No
Protocol article	SCFE protocol	01/03/2020	12/05/2020	Yes	No
Protocol article	protocol	01/03/2020	12/05/2020	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/04/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
01/09/2021: The study contact has been updated and the plain English summary has been updated accordingly.
12/05/2020: The following changes have been made:
1. Publication references added.
2. The public contact has been updated and the plain English summary has been updated accordingly.
13/03/2020: Internal review.