ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00850538

Registration number

NCT00850538

Ethics application status

Date submitted

23/02/2009

Date registered

25/02/2009

Date last updated

4/12/2015

Titles & IDs

Public title

Role of Bone in Knee Osteoarthritis (OA)

Scientific title

The Role of Bone and Its Measurement in Knee Osteoarthritis

Secondary ID [1]

NEBH 2008-018

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis, Knee

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Treatment: Other - MRI
Treatment: Surgery - Primary Total Knee Replacement

Treatment: Other: MRI
1.5T MRI exam of signal knee with knee coil (estimated time: 35 minutes)

Treatment: Surgery: Primary Total Knee Replacement
Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of Participants With Viable Specimens for Genetic Analysis

Timepoint [1]

Tissue samples collected at time of surgery

Eligibility

Key inclusion criteria

* subjects having primary knee replacement surgery with 1 participating surgeon at NEBH (principal investigator)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* subjects having a revision knee replacement instead of a primary knee replacement
* contraindications for MRI
* pregnancy

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/07/2008

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/04/2013

Sample size

Target

Accrual to date

Final

101

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

University of Sydney - Sydney

Recruitment postcode(s) [1]

02120 - Sydney

Funding & Sponsors

Primary sponsor type

Other

Name

The New England Baptist Hospital

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of the study is to investigate protein and gene expression among damaged knee tissues. We will perform MRI's on subjects prior to total knee replacement to identify the location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus specimens normally discarded from total joint replacements will be used for live cell harvest, and protein and gene expression analyses of tissue or cultured cells.

Trial website

https://clinicaltrials.gov/study/NCT00850538

Trial related presentations / publications

Burr DB. The importance of subchondral bone in the progression of osteoarthritis. J Rheumatol Suppl. 2004 Apr;70:77-80. No abstract available.
Felson DT, Chaisson CE, Hill CL, Totterman SM, Gale ME, Skinner KM, Kazis L, Gale DR. The association of bone marrow lesions with pain in knee osteoarthritis. Ann Intern Med. 2001 Apr 3;134(7):541-9. doi: 10.7326/0003-4819-134-7-200104030-00007.
Felson DT, McLaughlin S, Goggins J, LaValley MP, Gale ME, Totterman S, Li W, Hill C, Gale D. Bone marrow edema and its relation to progression of knee osteoarthritis. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):330-6. doi: 10.7326/0003-4819-139-5_part_1-200309020-00008.
Lo GH, Hunter DJ, Zhang Y, McLennan CE, Lavalley MP, Kiel DP, McLean RR, Genant HK, Guermazi A, Felson DT. Bone marrow lesions in the knee are associated with increased local bone density. Arthritis Rheum. 2005 Sep;52(9):2814-21. doi: 10.1002/art.21290.
Hunter DJ, Zhang Y, Niu J, Goggins J, Amin S, LaValley MP, Guermazi A, Genant H, Gale D, Felson DT. Increase in bone marrow lesions associated with cartilage loss: a longitudinal magnetic resonance imaging study of knee osteoarthritis. Arthritis Rheum. 2006 May;54(5):1529-35. doi: 10.1002/art.21789.
Zanetti M, Bruder E, Romero J, Hodler J. Bone marrow edema pattern in osteoarthritic knees: correlation between MR imaging and histologic findings. Radiology. 2000 Jun;215(3):835-40. doi: 10.1148/radiology.215.3.r00jn05835.
Neuhold A, Hofmann S, Engel A, Leder K, Kramer J, Haller J, Plenk H. Bone marrow edema of the hip: MR findings after core decompression. J Comput Assist Tomogr. 1992 Nov-Dec;16(6):951-5. doi: 10.1097/00004728-199211000-00023.
Plenk H Jr, Hofmann S, Eschberger J, Gstettner M, Kramer J, Schneider W, Engel A. Histomorphology and bone morphometry of the bone marrow edema syndrome of the hip. Clin Orthop Relat Res. 1997 Jan;(334):73-84.
Reinus WR, Fischer KC, Ritter JH. Painful transient tibial edema. Radiology. 1994 Jul;192(1):195-9. doi: 10.1148/radiology.192.1.8208937.
Hunter DJ, Lo GH, Gale D, Grainger AJ, Guermazi A, Conaghan PG. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008 Feb;67(2):206-11. doi: 10.1136/ard.2006.066183. Epub 2007 May 1.
Kornaat PR, Bloem JL, Ceulemans RY, Riyazi N, Rosendaal FR, Nelissen RG, Carter WO, Hellio Le Graverand MP, Kloppenburg M. Osteoarthritis of the knee: association between clinical features and MR imaging findings. Radiology. 2006 Jun;239(3):811-7. doi: 10.1148/radiol.2393050253.
Hayes CW, Jamadar DA, Welch GW, Jannausch ML, Lachance LL, Capul DC, Sowers MR. Osteoarthritis of the knee: comparison of MR imaging findings with radiographic severity measurements and pain in middle-aged women. Radiology. 2005 Dec;237(3):998-1007. doi: 10.1148/radiol.2373041989. Epub 2005 Oct 26.
Simkin PA. Bone pain and pressure in osteoarthritic joints. Novartis Found Symp. 2004;260:179-86; discussion 186-90, 277-9.
Mach DB, Rogers SD, Sabino MC, Luger NM, Schwei MJ, Pomonis JD, Keyser CP, Clohisy DR, Adams DJ, O'Leary P, Mantyh PW. Origins of skeletal pain: sensory and sympathetic innervation of the mouse femur. Neuroscience. 2002;113(1):155-66. doi: 10.1016/s0306-4522(02)00165-3.
Hukkanen M, Konttinen YT, Rees RG, Gibson SJ, Santavirta S, Polak JM. Innervation of bone from healthy and arthritic rats by substance P and calcitonin gene related peptide containing sensory fibers. J Rheumatol. 1992 Aug;19(8):1252-9.
Hunter DJ, Gerstenfeld L, Bishop G, Davis AD, Mason ZD, Einhorn TA, Maciewicz RA, Newham P, Foster M, Jackson S, Morgan EF. Bone marrow lesions from osteoarthritis knees are characterized by sclerotic bone that is less well mineralized. Arthritis Res Ther. 2009;11(1):R11. doi: 10.1186/ar2601. Epub 2009 Jan 26.

Public notes

Contacts

Principal investigator

Name

David Hunter, MD

Address

University of Sydney

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00850538

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00850538