Trial record 1 of 1 for:    NCT00294528
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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

February 21, 2006
February 21, 2006
January 2004
Not Provided
  • ROM
  • Pain
  • Satisfaction
  • Feel of prosthesis
  • Gait analysis
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis, Knee
Device: Nexgen LPS-flex and AGC
Not Provided
Thomsen MG, Husted H, Otte KS, Holm G, Troelsen A. Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial. BMC Musculoskelet Disord. 2013 Apr 8;14:127. doi: 10.1186/1471-2474-14-127.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2010
Not Provided

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
Both
18 Years to 75 Years
No
Contact: Henrik Husted, consultant +45 36326037 henrik.husted@hh.hosp.dk
Contact: Kristian Stahl-Otte, consultant +45 36326037
Denmark
 
NCT00294528
1
Not Provided
Not Provided
Hvidovre University Hospital
Not Provided
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
Hvidovre University Hospital
October 2003

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