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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:
Martina Hansen's Hospital
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: September 12, 2016
Last verified: September 2016
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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 Tor Kjetil Nerhus, Martina Hansen's Hospital:
Primary Outcome Measures:
- 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:
- Range of Motion [ Time Frame: Preoperative until 2 years postoperatively ]
- Oxford Knee Score [ Time Frame: Preoperative until 2 years postoperatively ]
- UCLA Score [ Time Frame: Preoperative until 2 years postoperatively ]
- Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ]
- Oxford Knee Score [ Time Frame: 10 years postoperatively ]
| 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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032538
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
| 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 ) |
| Study First Received: | December 14, 2009 |
| Results First Received: | October 25, 2013 |
| Last Updated: | September 12, 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 |
ClinicalTrials.gov processed this record on August 17, 2017