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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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
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

No publications provided

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

Keywords provided by Hvidovre University Hospital:
osteoarthritis, knee
total knee arthroplasty
range of motion
satisfaction

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013