NCT02883907

Brief Summary

The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:

  1. 1.Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult.
  2. 2.Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.
  3. 3.Calculating effect sizes for MR measurements to inform sample size calculations for future studies.
  4. 4.Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

August 22, 2016

Last Update Submit

January 11, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Mean cartilage T1rho relaxation time (milliseconds)

    1 year

  • Mean cartilage T2 relaxation time (milliseconds)

    1 year

  • Mean cartilage T1 relaxation time post gadolinium (milliseconds)

    Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)

    1 year

Secondary Outcomes (6)

  • Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)

    1 year

  • Cartilage thickness values (millimeters)

    1 year

  • Subchondral bone area (millimeters squared)

    1 year

  • Dynamic contrast enhanced (DCE) quantitation of parameters

    1 year

  • Subchondral bone texture index (arbitrary units)

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Healthy volunteers

Osteoarthritis patients

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group 1 will consist of 10 patients aged 40-60 who have presented to the Orthopaedic clinic with a painful knee, and have mild/moderate OA on plain radiographs (Kellgren-Lawrence grade 2-3). Group 2 will consist of 5 healthy volunteer controls, matched (1:2 ratio) to cases for age, sex and body mass index who do not have knee pain.

You may qualify if:

  • Meets American College of Rheumatology (ACR) criteria for OA
  • Kellgren-Lawrence grade 2-3 OA on knee radiograph
  • Medial compartment predominant disease
  • Neutral alignment
  • Aged 40-60
  • Body Mass Index (BMI) \< 35 kg per square meter
  • Ambulatory and in good general health
  • No current symptoms of knee pain or stiffness or other clinical features of OA
  • Aged 40-60
  • BMI \< 35 kg per square meter
  • Ambulatory and in good general health

You may not qualify if:

  • History of ipsilateral lower limb fracture
  • History of ipsilateral lower limb surgery (including arthroscopy)
  • Metabolic bone disease
  • Inflammatory arthritis
  • Haematological malignancy
  • Paget's disease
  • Bone metastases
  • Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
  • Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for cartilage turnover marker measurement

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

April 27, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

GB(1)