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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

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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