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NCT01030848 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01030848
Other study ID # TKN-001
Secondary ID 19039 (NSD)
Status Unknown status
Phase N/A
First received December 11, 2009
Last updated December 14, 2009
Start date February 2003
Est. completion date September 2013

Study information
Verified date December 2009
Source Martina Hansen's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date September 2013
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- patients with knee osteoarthritis

- admitted for total knee replacement

- no rheumatoid arthritis

- no previous knee infection

- age 40-85 years

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Total Knee Replacement (LCS rotating platform)

Locations
Country Name City State
Norway Martina Hansens Hospital Bærum

Sponsors (1)
Lead Sponsor Collaborator
Martina Hansen's Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee injury and Osteoarthritis Outcome Score Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Secondary Range of Motion (ROM) Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Secondary Knee injury and Osteoarthritis Outcome Score 10 years postoperatively
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