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Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR

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ClinicalTrials.gov Identifier: NCT01030848
Recruitment Status : Unknown
Verified December 2009 by Martina Hansen's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 14, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Martina Hansen's Hospital

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 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.

Condition or disease Intervention/treatment
Osteoarthritis Total Knee Replacement Device: Total Knee Replacement (LCS rotating platform)

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS
Study Start Date : February 2003
Actual Primary Completion Date : September 2007
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with knee osteoarthritis Device: Total Knee Replacement (LCS rotating platform)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Range of Motion (ROM) [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively ]
  2. Knee injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
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
Criteria

Inclusion Criteria:

  • patients with knee osteoarthritis
  • admitted for total knee replacement
  • no rheumatoid arthritis
  • no previous knee infection
  • age 40-85 years

Exclusion Criteria:


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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): NCT01030848


Locations
Norway
Martina Hansens Hospital
Bærum, Norway, 1306
Sponsors and Collaborators
Martina Hansen's Hospital
Investigators
Principal Investigator: Tor Kjetil Nerhus, MD Martina Hansens Hospital

Responsible Party: Tor Kjetil Nerhus/ Consultant orthopaedic surgeon, Martina Hansens Hospital
ClinicalTrials.gov Identifier: NCT01030848     History of Changes
Other Study ID Numbers: TKN-001
19039 (NSD) ( Registry Identifier: Norwegian Privacy Ombudsman for Research )
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

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