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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00937170
Other study ID # 09-036C-2
Secondary ID RMM001
Status Withdrawn
Phase N/A
First received July 9, 2009
Last updated January 20, 2011
Start date June 2009
Est. completion date December 2009

Study information

Verified date January 2011
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- clinical diagnosis of end-stage degenerative joint disease of the knee

- must be deemed appropriate for total knee replacement surgery

Exclusion Criteria:

- severe flexion deformity of the knee

- greater than 20deg varus or valgus malalignment

- osteomyelitis, septicemia, prior infection of the knee joint

- presence of infections or highly communicable diseases

- significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity

- metastatic disease

- congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success

- previous total knee replacement in affected knee

- arthrodesis of the affected knee

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Zimmer LPS flex Gender Specific Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Zimmer High Flex LPS Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Stryker Triathlon Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Health Center Stryker Orthopaedics

Outcome

Type Measure Description Time frame Safety issue
Primary Evidence of improved pain relief and function Pre-op, 4 weeks, 4 months, 1 year, 2 years No
Secondary Evidence of improved patellofemoral biomechanics Pre-op, 4 months, 1 year No
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