NCT00850538

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 Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

December 4, 2015

Completed
Last Updated

December 4, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

February 23, 2009

Results QC Date

May 15, 2013

Last Update Submit

November 2, 2015

Conditions

Osteoarthritis, Knee

Keywords

Bone Marrow LesionBMLArthroplastyReplacementKneeDiscarded tissue

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Viable Specimens for Genetic Analysis

    Tissue samples collected at time of surgery

Interventions

MRIRADIATION

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

Primary Total Knee ReplacementPROCEDURE

Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female, over age 18, with scheduled primary total knee replacement surgery at NEBH, with no contradindications for MRI

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 02120, Australia

Location

Related Publications (16)

  • Burr DB. The importance of subchondral bone in the progression of osteoarthritis. J Rheumatol Suppl. 2004 Apr;70:77-80. No abstract available.

    PMID: 15132360BACKGROUND

  • 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.

    PMID: 11281736BACKGROUND

  • 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.

    PMID: 12965941BACKGROUND

  • 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.

    PMID: 16145676BACKGROUND

  • 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.

    PMID: 16646037BACKGROUND

  • 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.

    PMID: 10831707BACKGROUND

  • 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.

    PMID: 1430447BACKGROUND

  • 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.

    PMID: 9005898BACKGROUND

  • Reinus WR, Fischer KC, Ritter JH. Painful transient tibial edema. Radiology. 1994 Jul;192(1):195-9. doi: 10.1148/radiology.192.1.8208937.

    PMID: 8208937BACKGROUND

  • 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.

    PMID: 17472995BACKGROUND

  • 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.

    PMID: 16714463BACKGROUND

  • 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.

    PMID: 16251398BACKGROUND

  • Simkin PA. Bone pain and pressure in osteoarthritic joints. Novartis Found Symp. 2004;260:179-86; discussion 186-90, 277-9.

    PMID: 15283450BACKGROUND

  • 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.

    PMID: 12123694BACKGROUND

  • 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.

    PMID: 1383542BACKGROUND

  • 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.

    PMID: 19171047BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tibial plateau patella fat pad synovial fluid and synovium

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Carl Talmo
Organization
New England Baptist Hospital
ctalmo@nebh.org
617-724-5474

Study Officials

  • David Hunter, MD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 4, 2015

Results First Posted

December 4, 2015

Record last verified: 2015-11

Locations

AU(1)