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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01030848
First received: December 11, 2009
Last updated: December 14, 2009
Last verified: December 2009
History of Changes
  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 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 Intervention
Osteoarthritis
Total Knee Replacement
 Device: Total Knee Replacement (LCS rotating platform)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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, 2 years and 4 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of Motion (ROM) [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively ] [ Designated as safety issue: No ]
  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2003
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with knee osteoarthritis Device: Total Knee Replacement (LCS rotating platform)
.

  Eligibility

Ages Eligible for Study:   40 Years to 85 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

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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)
Study First Received: December 11, 2009
Last Updated: December 14, 2009
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on May 16, 2013