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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:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tor Kjetil Nerhus, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01032538
First received: December 14, 2009
Last updated: January 3, 2015
Last verified: October 2013
  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:


Further study details as provided by Martina Hansen's Hospital:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
    Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.


Secondary Outcome Measures:
  • Range of Motion [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
  • Oxford Knee Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
  • UCLA Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ] [ Designated as safety issue: No ]
  • Oxford Knee Score [ Time Frame: 10 years postoperatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: December 14, 2009
Results First Received: October 25, 2013
Last Updated: January 3, 2015
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Martina Hansen's Hospital:
Unicondylar Knee Replacement

ClinicalTrials.gov processed this record on February 27, 2015