Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR

December 14, 2009 updated by: Martina Hansen's Hospital

Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bærum, Norway, 1306
        • Martina Hansens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital

Description

Inclusion Criteria:

  • patients with knee osteoarthritis
  • admitted for total knee replacement
  • no rheumatoid arthritis
  • no previous knee infection
  • age 40-85 years

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with knee osteoarthritis
Device: Total Knee Replacement (LCS rotating platform)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee injury and Osteoarthritis Outcome Score
Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of Motion (ROM)
Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Knee injury and Osteoarthritis Outcome Score
Time Frame: 10 years postoperatively
10 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martina Hansen's Hospital

Investigators

  • Principal Investigator: Tor Kjetil Nerhus, MD, Martina Hansens Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKN-001
  • 19039 (NSD) (Registry Identifier: Norwegian Privacy Ombudsman for Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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