NCT02603939

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

8.5 years

First QC Date

November 10, 2015

Last Update Submit

October 23, 2020

Conditions

OsteoarthritisPain

Keywords

PainMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC)

    Western Ontario and McMaster Universities Index (WOMAC)

    1 Year after joint replacement

Secondary Outcomes (1)

  • Magnetic Resonance Imaging Knee Osteoarthritis Score

    Pre-operatively

Study Arms (2)

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

Procedure: 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

Interventions

Joint replacement surgeryPROCEDURE

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

Participants with Advanced Knee OA

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery

You may qualify if:

  • Study participant will be recruited from rheumatology outpatient clinics and primary care:
  • fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
  • male or female,
  • symptomatic knee pain
  • on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
  • 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:
  • fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
  • male or female,
  • symptomatic knee pain
  • on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
  • Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee surgery
  • \. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a comparator group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotung Centre for Musculoskeletal Diseases

London, SW17 ORE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood collected

MeSH Terms

Conditions

OsteoarthritisPain

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Nidhi Sofat, MBBS, PhD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abiola Harrison, BSc

CONTACT

020 8266 6474oharriso@sgul.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 13, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations

GB(1)