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

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ClinicalTrials.gov Identifier: NCT01032538
Recruitment Status : Active, not recruiting
First Posted : December 15, 2009
Results First Posted : January 13, 2015
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tor Kjetil Nerhus, Martina Hansen's Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Osteoarthritis

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!

Study Design
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Study Type : Observational
Actual Enrollment : 99 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : February 2009
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Patients with knee osteoarthritis
Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Range of Motion [ Time Frame: Preoperative until 2 years postoperatively ]
  2. Oxford Knee Score [ Time Frame: Preoperative until 2 years postoperatively ]
  3. UCLA Score [ Time Frame: Preoperative until 2 years postoperatively ]
  4. Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ]
  5. Oxford Knee Score [ Time Frame: 10 years postoperatively ]

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 15, 2009    Key Record Dates
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