Overview

This trial is active, not recruiting.

Conditions osteoarthritis, total knee replacement
Treatment total knee replacement (lcs rotating platform)
Sponsor Martina Hansen's Hospital
Start date February 2003
End date September 2007
Trial size 50 participants
Trial identifier NCT01030848, 19039 (NSD), TKN-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
total knee replacement (lcs rotating platform)
.

Primary Outcomes

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

Secondary Outcomes

Measure
Range of Motion (ROM)
time frame: 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

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - patients with knee osteoarthritis - admitted for total knee replacement - no rheumatoid arthritis - no previous knee infection - age 40-85 years Exclusion Criteria: -

Additional Information

Official title Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS
Principal investigator Tor Kjetil Nerhus, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Martina Hansen's Hospital.