NCT00937170

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable knee-osteoarthritis

Status
withdrawn

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

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

July 9, 2009

Last Update Submit

January 20, 2011

Conditions

Knee Osteoarthritis

Keywords

Total Knee ReplacementGender Specific Design

Outcome Measures

Primary Outcomes (1)

  • Evidence of improved pain relief and function

    Pre-op, 4 weeks, 4 months, 1 year, 2 years

Secondary Outcomes (1)

  • Evidence of improved patellofemoral biomechanics

    Pre-op, 4 months, 1 year

Study Arms (3)

Gender Specific LPS flex

EXPERIMENTAL

Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design

Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)

LPS flex

ACTIVE COMPARATOR

Participants in this arm will receive the Zimmer High Flex LPS implant

Device: Zimmer High Flex LPS Implant (Total knee replacement)

Triathlon

ACTIVE COMPARATOR

Participants in this arm will receive the Stryker Triathlon Implant design

Device: Stryker Triathlon Implant (Total knee replacement)

Interventions

Zimmer LPS flex Gender Specific Implant (Total knee replacement)DEVICE

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

Gender Specific LPS flex
Zimmer High Flex LPS Implant (Total knee replacement)DEVICE

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

LPS flex
Stryker Triathlon Implant (Total knee replacement)DEVICE

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

Triathlon

Eligibility Criteria

Age40 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of end-stage degenerative joint disease of the knee
  • must be deemed appropriate for total knee replacement surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • R. Michael Meneghini, M.D.

    University of Connecticut Health Center, Farmington CT, United States

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 21, 2011

Record last verified: 2011-01