Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-01-12
2032-12-31
Brief Summary
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A number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.
We will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.
Over the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Participant undergoing orthopaedic surgery
* Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, elbow, ankle).
* Patients with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.
* Patients undergoing acute low-velocity or fragility fracture fixation surgery.
Relevant orthopaedic surgery
Inclusion criteria is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant.
Interventions
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Relevant orthopaedic surgery
Inclusion criteria is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant.
Eligibility Criteria
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Inclusion Criteria
2. Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.
3. Patients undergoing acute low-velocity or fragility fracture fixation surgery.
4. Patients aged between 18-110 years old with capacity to consent.
Since deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).
Exclusion Criteria
2. Patients with suspected/established underlying malignancy.
3. Patients with suspected/established osteomyelitis.
4. Patients with suspected/established bloodborne disease
5. Patients who are currently a subject of a clinical trial involving an investigational medicinal product.
18 Years
110 Years
ALL
No
Sponsors
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Harley Street Specialist Hospital
UNKNOWN
Fitzrovia Hospital
UNKNOWN
Royal Free Hospital NHS Foundation Trust
OTHER
Bedfordshire Hospitals NHS Foundation Trust
OTHER
Chelsea and Westminster NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
Royal National Orthopaedic Hospital NHS Trust
OTHER
Relation Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Raghbir Khakha
Role: PRINCIPAL_INVESTIGATOR
Harley Street Specialist Hospital & Fitzrovia Hospital/QASMC
Akash Patel
Role: PRINCIPAL_INVESTIGATOR
Royal Free London NHS Foundation Trust
Yegappan Kalairajah
Role: PRINCIPAL_INVESTIGATOR
Luton & Dunstable University Hospital, Bedfordshire Hospitals NHS Foundation Trust
Victor Babu
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Jonathan Ward
Role: PRINCIPAL_INVESTIGATOR
Barts & The London NHS Trust
Richard Keen
Role: PRINCIPAL_INVESTIGATOR
Royal National Orthopaedic Hospital NHS Trust
Ines Reichert
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
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Harley Street Specialist Hospital
London, Greater London, United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Chase Farm Hospital
London, , United Kingdom
Fitzrovia Hospital/QASMC
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Luton & Dunstable University Hospital
London, , United Kingdom
Royal National Orthopaedic Hospital NHS Trust
London, , United Kingdom
West Middlesex University Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Richard Keen
Role: primary
Other Identifiers
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RRx-Profiling-001
Identifier Type: -
Identifier Source: org_study_id
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