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: January 3, 2015
Last verified: October 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 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, and 2 years postoperatively ] [ Designated as safety issue: No ]Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.
Secondary Outcome Measures:
- Range of Motion [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
- Oxford Knee Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
- UCLA Score [ Time Frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: No ]
- Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 10 years postoperatively ] [ Designated as safety issue: No ]
- Oxford Knee Score [ Time Frame: 10 years postoperatively ] [ Designated as safety issue: No ]
| 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) |
| 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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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) |
| Study First Received: | December 14, 2009 |
| Results First Received: | October 25, 2013 |
| Last Updated: | January 3, 2015 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by 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 September 27, 2016