Identifying factors that regulate bone health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on understanding the cellular mechanisms that maintain bone homeostasis and how they relate to diseases such as osteoporosis and osteoarthritis. By recruiting patients undergoing various orthopedic surgeries, the study aims to analyze surgical bone waste to identify potential therapeutic targets for preventing bone diseases. The research will consider a wide range of factors that may contribute to bone health, including genetics, diet, and age. The goal is to develop a deeper understanding of bone disorders and improve treatment options for affected patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).
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).

We note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.

Exclusion Criteria:

1. Patients unable to provide informed consent.
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.

Where it's running

• Barts Health NHS Trust
  London, United Kingdom Recruiting
• Chase Farm Hospital
  London, United Kingdom Recruiting
• Fitzrovia Hospital/QASMC
  London, United Kingdom Recruiting
• West Middlesex University Hospital
  London, United Kingdom Recruiting
• Harley Street Specialist Hospital
  London, Greater London, United Kingdom Active not recruiting
• King's College Hospital
  London, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Raghbir Khakha — Harley Street Specialist Hospital & Fitzrovia Hospital/QASMC
• Study coordinator: Jake Taylor-King, DPhil
• Email: jake@relationrx.com
• Phone: 447387227904

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.