Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Nexgen LPS-flex and AGC
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
Eligibility 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
Sites / Locations
- orthopedic department, section of arthroplasty, Hvidovre University HospitalRecruiting
Outcomes
Primary Outcome Measures
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT00294528
First Posted
February 21, 2006
Last Updated
February 21, 2006
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00294528
Brief Title
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
Official Title
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
Study Type
Interventional
2. Study Status
Record Verification Date
October 2003
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Nexgen LPS-flex and AGC
Primary Outcome Measure Information:
Title
ROM
Title
Pain
Title
Satisfaction
Title
Feel of prosthesis
Title
Gait analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Husted, consultant
Phone
+45 36326037
Email
henrik.husted@hh.hosp.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian Stahl-Otte, consultant
Phone
+45 36326037
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Husted, consultant
Organizational Affiliation
head of arthroplasty section
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristian Stahl Otte, consultant
Organizational Affiliation
arthroplasty section
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gitte Holm, RN
Organizational Affiliation
Head nurse of arthroplasty section
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helle Krogshøj Hansen, RN
Organizational Affiliation
nurse
Official's Role
Principal Investigator
Facility Information:
Facility Name
orthopedic department, section of arthroplasty, Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Husted, consultant
Phone
+45 36326037
Email
henrik.husted@hh.hosp.dk
First Name & Middle Initial & Last Name & Degree
henrik husted, consultant
12. IPD Sharing Statement
Citations:
PubMed Identifier
23565578
Citation
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.
Results Reference
derived
Learn more about this trial
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
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