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Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Primary Purpose

Knee Osteoarthritis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Zimmer LPS flex Gender Specific Implant (Total knee replacement)

Zimmer High Flex LPS Implant (Total knee replacement)

Stryker Triathlon Implant (Total knee replacement)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Replacement, Gender Specific Design

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Gender Specific LPS flex

LPS flex

Triathlon

Arm Description

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

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

Participants in this arm will receive the Stryker Triathlon Implant design

Outcomes

Primary Outcome Measures

Evidence of improved pain relief and function

Secondary Outcome Measures

Evidence of improved patellofemoral biomechanics

Full Information

NCT ID

NCT00937170

First Posted

July 9, 2009

Last Updated

January 20, 2011

Sponsor

UConn Health

Collaborators

Stryker Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT00937170

Brief Title

Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Withdrawn

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

UConn Health

Collaborators

Stryker Orthopaedics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Total Knee Replacement, Gender Specific Design

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gender Specific LPS flex

Arm Type

Experimental

Arm Description

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

Arm Title

LPS flex

Arm Type

Active Comparator

Arm Description

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

Arm Title

Triathlon

Arm Type

Active Comparator

Arm Description

Participants in this arm will receive the Stryker Triathlon Implant design

Intervention Type

Device

Intervention Name(s)

Zimmer LPS flex Gender Specific Implant (Total knee replacement)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Zimmer High Flex LPS Implant (Total knee replacement)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Stryker Triathlon Implant (Total knee replacement)

Intervention Description

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

Primary Outcome Measure Information:

Title

Evidence of improved pain relief and function

Time Frame

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

Secondary Outcome Measure Information:

Title

Evidence of improved patellofemoral biomechanics

Time Frame

Pre-op, 4 months, 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R. Michael Meneghini, M.D.

Organizational Affiliation

University of Connecticut Health Center, Farmington CT, United States

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

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