NCT00901329

Brief Summary

The purpose of this trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur (weight).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 13, 2009

Status Verified

May 1, 2009

Enrollment Period

2.6 years

First QC Date

May 12, 2009

Last Update Submit

May 12, 2009

Conditions

Total Knee Arthroplasty

Keywords

TKAfunctional outcomepainROMgait

Outcome Measures

Primary Outcomes (1)

  • follow-up at 6 weeks, 3 months, 6 months and one year. - knee-score and function score - feel of prosthesis (VAS 0-10) - ROM (max passive and active ROM is measured using a goniometer) - pain (VAS 0-10) - satisfaction (VAS 0-10)

    1 year

Study Arms (2)

1: Gender prosthesis

EXPERIMENTAL
Device: NexGen Gender Fixed Bearing Knee prosthesis

2: LPS flex prosthesis

ACTIVE COMPARATOR
Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis

Interventions

NexGen Gender Fixed Bearing Knee prosthesisDEVICE

new female prosthesis

1: Gender prosthesis
NexGen LPS-Flex Fixed Bearing Knee prosthesisDEVICE

standard knee prosthesis

2: LPS flex prosthesis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients scheduled for simultaneous bilateral total knee arthroplasty (TKA) are included
  • bilateral knee disease necessitating bilateral TKA

You may not qualify if:

  • male sex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

orthopedic department, section of arthroplasty, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

May 13, 2009

Record last verified: 2009-05

Locations

DK(2)