Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Knee Osteoarthritis Clinical Trial

Official title:

A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• Knee Osteoarthritis
• Osteoarthritis, Knee

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