British orthopaedic surgery surveillance study | Not Recruiting
British orthopaedic surgery surveil... | Not Recruiting
British orthopaedic surgery surveillance study
BOSS

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Medical Conditions
  • 1. Slipped Capital Femoral Epiphysis (SCFE) 2. Perthes' disease
Primary Contact Details
Mr Daniel Perry
+44 7815 122361
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN54477575
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Research Details
  • 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.
Phase
Sorry, this information is not available
Study Design
Nationwide observational cohort study
Study Type
Observational
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 Measures
    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)
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Child
Who Can Participate
Patient
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 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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Alder Hey Children's Hospital, Alder Hey Children's Hospital NHS Foundation Trust
Liverpool
L14 5AB
Trial Contact(s)
Primary Trial Contact
Mr Daniel Perry
+44 7815 122361
Other Trial Contacts
Dr Emma Cwiklinski
+44 151 794 9772
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
UoL001157
Sponsor(s)
University of Liverpool
Key Dates

Recruitment Start Date

04 Apr 2016

Recruitment End Date

30 Sep 2017

Trial Start Date

01 Mar 2015

Trial End Date

01 Mar 2020

Date added to source

19 Apr 2017

Date updated in source

19 Apr 2017