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Role of Bone in Knee Osteoarthritis (OA)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850538
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : December 4, 2015
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
David Hunter, The New England Baptist Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoarthritis, Knee
Interventions Radiation: MRI
Procedure: Primary Total Knee Replacement
Enrollment 101
Recruitment Details Participants were recruited from 4 orthopedic surgeons at one hospital between the dates of March, 2009 and April, 2013.
Pre-assignment Details  
Arm/Group Title Enrolled
Hide Arm/Group Description

Inclusion Criteria:

- subjects having primary knee replacement surgery

Exclusion Criteria:

  • having a revision knee replacement instead of a primary knee replacement
  • contraindicated for MRI or CT scans
  • allergy to the contrast agent gadolinium
  • pregnant women
Period Title: Overall Study
Started 101
Completed 60
Not Completed 41
Reason Not Completed
unable/unwilling to complete MRI             13
specimen missed due to scheduling error             14
specimen unusable             7
Withdrawal by Subject             3
radiology error             2
Protocol Violation             2
Arm/Group Title Enrolled
Hide Arm/Group Description

Subjects having primary knee replacement surgery

Exclusion Criteria:

  • having a revision knee replacement instead of a primary knee replacement
  • contraindicated for MRI or CT scans
  • allergy to the contrast agent gadolinium
  • pregnant women
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
<=18 years
0
   0.0%
Between 18 and 65 years
55
  54.5%
>=65 years
46
  45.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
63.89  (8.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
50
  49.5%
Male
51
  50.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants
101
1.Primary Outcome
Title Number of Participants With Viable Specimens for Genetic Analysis
Hide Description [Not Specified]
Time Frame Tissue samples collected at time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Specimens
Hide Arm/Group Description:
Viable specimens for genetic analysis
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrolled
Hide Arm/Group Description subjects having primary knee replacement surgery
All-Cause Mortality
Enrolled
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Enrolled
Affected / at Risk (%)
Total   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Enrolled
Affected / at Risk (%)
Total   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carl Talmo
Organization: New England Baptist Hospital
Phone: 617-724-5474
EMail: ctalmo@nebh.org
Publications:
Layout table for additonal information
Responsible Party: David Hunter, The New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT00850538    
Other Study ID Numbers: NEBH 2008-018
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: May 15, 2013
Results First Posted: December 4, 2015
Last Update Posted: December 4, 2015