NCT00294528

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 22, 2006

Status Verified

October 1, 2003

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, kneetotal knee arthroplastyrange of motionsatisfaction

Outcome Measures

Primary Outcomes (5)

  • ROM

  • Pain

  • Satisfaction

  • Feel of prosthesis

  • Gait analysis

Interventions

Nexgen LPS-flex and AGCDEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age below 75 years and active
  • preop ROM at least 120 degress flexion
  • BMI below 30
  • intact ligaments

You may not qualify if:

  • below 18 years
  • unable to understand language or purpose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

orthopedic department, section of arthroplasty, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23565578DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneePersonal Satisfaction

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Husted, consultant

CONTACT

+45 36326037henrik.husted@hh.hosp.dk

Kristian Stahl-Otte, consultant

CONTACT

+45 36326037

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

January 1, 2004

Study Completion

January 1, 2010

Last Updated

February 22, 2006

Record last verified: 2003-10

Locations

DK(1)