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Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032538
First Posted: December 15, 2009
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tor Kjetil Nerhus, Martina Hansen's Hospital
  Purpose
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.

Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tor Kjetil Nerhus, Martina Hansen's Hospital:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Preoperative until 2 years postoperatively ]
    Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.


Secondary Outcome Measures:
  • Range of Motion [ Time Frame: Preoperative until 2 years postoperatively ]
  • Oxford Knee Score [ Time Frame: Preoperative until 2 years postoperatively ]
  • UCLA Score [ Time Frame: Preoperative until 2 years postoperatively ]
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ]
  • Oxford Knee Score [ Time Frame: 10 years postoperatively ]
Enrollment: 99
Study Start Date: November 2003
Estimated Study Completion Date: February 2017
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with knee osteoarthritis
Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee

Detailed Description:
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. Thats it!
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital, Akershus University Hospital and Baerum hospital
Criteria

Inclusion Criteria:

  • patients with medial knee osteoarthritis
  • admitted for unicondylar knee replacement
  • age 50-80 years

Exclusion criteria

  • rheumatoid arthritis
  • previous knee infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032538


Locations
Norway
Bærum Sykehus
Bærum, Akershus, Norway, 1309
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Martina Hansens Hospital
Bærum, Norway, 1306
Sponsors and Collaborators
Martina Hansen's Hospital
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Tor Kjetil Nerhus, MD Martina Hansens Hospital
  More Information

Responsible Party: Tor Kjetil Nerhus, Consultant Orthopaedic surgeon, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT01032538     History of Changes
Other Study ID Numbers: TKN-002
19441 (NSD) ( Registry Identifier: Norwegian Privacy Ombudsman for Research )
First Submitted: December 14, 2009
First Posted: December 15, 2009
Results First Submitted: October 25, 2013
Results First Posted: January 13, 2015
Last Update Posted: October 28, 2016
Last Verified: September 2016

Keywords provided by Tor Kjetil Nerhus, Martina Hansen's Hospital:
Unicondylar Knee Replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases