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

This study is currently recruiting participants.

Verified by Hvidovre University Hospital, October 2003

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00294528

Purpose

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

Condition	Intervention	Phase
Osteoarthritis, Knee	Device: Nexgen LPS-flex and AGC	Phase IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis

Estimated Enrollment:	100
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2010

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294528

Contacts

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

Locations

Denmark, Hvidovre
orthopedic department, section of arthroplasty, Hvidovre University Hospital	Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Henrik Husted, consultant +45 36326037 henrik.husted@hh.hosp.dk
Principal Investigator: henrik husted, consultant

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

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

More Information

Study ID Numbers:	1
Study First Received:	February 21, 2006
Last Updated:	February 21, 2006
ClinicalTrials.gov Identifier:	NCT00294528
Health Authority:	Denmark: Scientific Board of Health

Keywords provided by Hvidovre University Hospital:

osteoarthritis, knee
total knee arthroplasty
range of motion
satisfaction

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009