Trial Outcomes & Findings for Role of Bone in Knee Osteoarthritis (OA) (NCT NCT00850538)

Results Overview

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

Tissue samples collected at time of surgery

Results posted on

2015-12-04

Participants were recruited from 4 orthopedic surgeons at one hospital between the dates of March, 2009 and April, 2013.

Participant milestones
Measure	Enrolled 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
Overall Study STARTED	101
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	41

Reasons for withdrawal
Measure	Enrolled 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
Overall Study unable/unwilling to complete MRI	13
Overall Study specimen missed due to scheduling error	14
Overall Study specimen unusable	7
Overall Study Withdrawal by Subject	3
Overall Study radiology error	2
Overall Study Protocol Violation	2

Role of Bone in Knee Osteoarthritis (OA)

Baseline characteristics by cohort
Measure	Enrolled n=101 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants
Age, Continuous	63.89 years STANDARD_DEVIATION 8.59 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants

Timeframe: Tissue samples collected at time of surgery

Outcome measures
Measure	Specimens n=60 Participants Viable specimens for genetic analysis
Number of Participants With Viable Specimens for Genetic Analysis	14 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

New England Baptist Hospital

Phone: 617-724-5474