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

NCT ID: NCT00294528

Last Updated: 2006-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Keywords

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osteoarthritis, knee total knee arthroplasty range of motion satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nexgen LPS-flex and AGC

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Henrik Husted, consultant

Role: PRINCIPAL_INVESTIGATOR

head of arthroplasty section

Kristian Stahl Otte, consultant

Role: PRINCIPAL_INVESTIGATOR

arthroplasty section

Gitte Holm, RN

Role: PRINCIPAL_INVESTIGATOR

Head nurse of arthroplasty section

Helle Krogshøj Hansen, RN

Role: PRINCIPAL_INVESTIGATOR

nurse

Locations

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orthopedic department, section of arthroplasty, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Henrik Husted, consultant

Role: CONTACT

Phone: +45 36326037

Email: [email protected]

Kristian Stahl-Otte, consultant

Role: CONTACT

Phone: +45 36326037

Facility Contacts

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Henrik Husted, consultant

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23565578 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id