Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2003 by Hvidovre University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT00294528

First received: February 21, 2006

Last updated: NA

Last verified: October 2003

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

February 21, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC

Official Title ^ICMJE

Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

Brief Summary

A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.

We want to:

determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
and if so, does it matter

Detailed Description

100 patients operated on with unilateral TKR are included and randomized to either prostheses.

Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Device: Nexgen LPS-flex and AGC

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

100

Completion Date

January 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age below 75 years and active
preop ROM at least 120 degress flexion
BMI below 30
intact ligaments

Exclusion Criteria:

below 18 years
unable to understand language or purpose

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Henrik Husted, consultant	+45 36326037	henrik.husted@hh.hosp.dk
Contact: Kristian Stahl-Otte, consultant	+45 36326037

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00294528

Other Study ID Numbers ^ICMJE

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hvidovre University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Henrik Husted, consultant	head of arthroplasty section
Principal Investigator:	Kristian Stahl Otte, consultant	arthroplasty section
Principal Investigator:	Gitte Holm, RN	Head nurse of arthroplasty section
Principal Investigator:	Helle Krogshøj Hansen, RN	nurse

Information Provided By

Hvidovre University Hospital

Verification Date

October 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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