Overview

This trial is active, not recruiting.

Condition osteoarthritis
Sponsor Martina Hansen's Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date November 2003
End date February 2009
Trial size 100 participants
Trial identifier NCT01032538, 19441 (NSD), TKN-002

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 six years following Oxford Medial Unicondylar Knee 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

Primary Outcomes

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

Secondary Outcomes

Measure
Range of Motion
time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively
Oxford knee score
time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively
UCLA score
time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively
Knee injury and Osteoarthritis Outcome Score
time frame: 6 years and 10 years postoperatively

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

Inclusion Criteria: - patients with medial knee osteoarthritis - admitted for unicondylar knee replacement - no rheumatoid arthritis - no previous knee infection - age 50-80 years

Additional Information

Official title Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement - A Prospective Longitudinal Study With Repetitive Measures of KOOS in 100 Patients
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.