NCT01335438

Brief Summary

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 1997

Longer than P75 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

January 1, 1997

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1998

Completed
13.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

April 11, 2011

Last Update Submit

October 4, 2011

Conditions

Osteoarthritis

Keywords

total knee arthroplastycementedcementlessfixationposterior stabilizedcruciate retaining

Outcome Measures

Primary Outcomes (1)

  • Improvement in Knee Society Knee Score

    change in knee score will be compared with initial score, until mean follow up of 25 years.

    Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Secondary Outcomes (1)

  • Improvement in the Range of Motion

    Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Study Arms (2)

Cementless Nexgen CR

EXPERIMENTAL

Cementless fixation of Nexgen CR TKR

Device: Cementless (Nexgen)

Cemented Nexgen CR

ACTIVE COMPARATOR

Cemented fixation of Nexgen CR TKR

Device: Cemented (Nexgen)

Interventions

Cementless (Nexgen)DEVICE

Cementless fixation of Nexgen CR TKR

Also known as: Cementless Nexgen
Cementless Nexgen CR
Cemented (Nexgen)DEVICE

Cemented fixation of Nexgen CR TKR

Also known as: Cemented Nexgen
Cemented Nexgen CR

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

You may not qualify if:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hosptial

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jang Won Park, MD

    Ewha Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 14, 2011

Study Start

January 1, 1997

Primary Completion

February 1, 1998

Study Completion

March 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

KR(1)