Comparing Clinical Outcome of 2 Different Total Knee Pros... | NCT00294528

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

NCT00294528

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Feb 22, 2006Estimated

Enrollment

100

Phase

Phase 4

Conditions

Osteoarthritis, Knee

Interventions

Nexgen LPS-flex and AGC

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Jan 2010

First Submitted Date

Feb 21, 2006

First Submission Date that Met QC Criteria

Feb 21, 2006

First Posted Date

Feb 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2006

Last Update Posted Date

Feb 22, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Nexgen LPS-flex and AGC	Device

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Henrik Husted, consultant	Contact	+45 36326037		henrik.husted@hh.hosp.dk
Kristian Stahl-Otte, consultant	Contact	+45 36326037

Overall Officials

Name	Affiliation	Role
Henrik Husted, consultant	head of arthroplasty section	Principal Investigator
Kristian Stahl Otte, consultant	arthroplasty section	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
orthopedic department, section of arthroplasty, Hvidovre University Hospital	Recruiting	Copenhagen	Hvidovre	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23565578	Derived	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.

Measure	Description	Time Frame
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis

ID	Term
D020370	Osteoarthritis, Knee
D010549	Personal Satisfaction

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases