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Understanding Pain Perception in Osteoarthritis

NCT ID: NCT02603939

Last Updated: 2020-10-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2022-12-31

Brief Summary

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Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately resulting in total joint replacement. In order to assess disease progression and plan surgery, x-rays are taken as part of routine practice. However x-rays provide limited information about formation of substructures and changes occurring during progression of disease. The proposed study aims to invite patients with OA of the hip or knee to participate in detailed examinations of their pain and their painful joint through interviews, blood and urine samples taken, MRI magnetic resonance imaging)and donating their waste tissue after joint surgery (all of old joint). Informed patient consent will be sought in all cases.

Detailed Description

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The patient will be asked for permission for a clinician to access their notes for information relevant to the research, including full medical history, their sex and date of birth. Tissue obtained from joint replacement surgery at St. George's Hospital and transferred to St.George's, University of London where it will be prepared for various experiments including looking at the genes and proteins in people with osteoarthritis. The blood and urine samples will also be taken to St. George's, University of London, and prepared for studies on the genes and proteins in people with osteoarthritis. All samples provided will be anonymised with no patient details on the samples and stored in locked freezers, in locked labs. at St.George's, University of London.

Conditions

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Osteoarthritis Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Advanced Knee OA

People with advanced knee osteoarthritis requiring joint replacement surgery are being assessed for their pain responses before and after joint replacement surgery

Joint replacement surgery

Intervention Type PROCEDURE

We are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery

Participants with Early Knee OA

Participants with osteoarthritis with early disease who do not require joint replacement surgery are being assessed for pain

No interventions assigned to this group

Interventions

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Joint replacement surgery

We are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. participants between 35 and 90 who will be undergoing knee replacement surgery or arthroscopy for osteoarthritis or knee surgery for fractured tibia/femur/fibula with osteoarthritis


Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee surgery


1\. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a comparator group
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nidhi Sofat, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

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Hotung Centre for Musculoskeletal Diseases

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Abiola Harrison, BSc

Role: CONTACT

[email protected]
020 8266 6474

Facility Contacts

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Lena Assi

Role: primary

[email protected]
020 8725 4220

Other Identifiers

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12.0056

Identifier Type: -

Identifier Source: org_study_id