NCT00916968

Brief Summary

The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

July 2, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

June 9, 2009

Last Update Submit

July 1, 2009

Conditions

Osteoarthritis

Keywords

Gender specificcruciate retainingtotal knee arthroplastyBilateral Osteoarthritis of the knee joint

Outcome Measures

Primary Outcomes (1)

  • Knee Society Knee Score

    2 years

Secondary Outcomes (1)

  • Implant or bone overhang

    2 years

Study Arms (2)

Standard CR-Flex

ACTIVE COMPARATOR
Device: Standard CR-Flex total knee

Gender specific CR-Flex

EXPERIMENTAL
Device: Gender specific CR-Flex

Interventions

Standard CR-Flex total kneeDEVICE

total knee implant used for joint replacement surgery of the knee

Also known as: Zimmer, Nexgen CR-flex
Standard CR-Flex
Gender specific CR-FlexDEVICE

TKA by Gender specific Nexgen CR-Flex

Also known as: Gender Specific Nexgen CR-Flex implant
Gender specific CR-Flex

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

You may not qualify if:

  • Inflammatory arthritis
  • Osteoarthritis effecting hip joint
  • Traumatic arthritis
  • Neurologic disorders affecting motor function of lower extremity
  • foot and ankle disorders limiting ambulation of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yoowang Choi, MD

    Ewha Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

February 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2009

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

KR(1)