Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement
2 other identifiers
observational
99
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2003
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedResults Posted
Study results publicly available
January 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedDecember 1, 2023
November 1, 2023
5.3 years
December 14, 2009
October 25, 2013
November 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Injury and Osteoarthritis Outcome Score
Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.
Preoperative until 2 years postoperatively
Secondary Outcomes (5)
Range of Motion
Preoperative until 2 years postoperatively
Oxford Knee Score
Preoperative until 2 years postoperatively
UCLA Score
Preoperative until 2 years postoperatively
Knee Injury and Osteoarthritis Outcome Score
10 years postoperatively
Oxford Knee Score
10 years postoperatively
Study Arms (1)
Patients with knee osteoarthritis
Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee
Eligibility Criteria
Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital, Akershus University Hospital and Baerum hospital
You may qualify if:
- patients with medial knee osteoarthritis
- admitted for unicondylar knee replacement
- age 50-80 years
You may not qualify if:
- rheumatoid arthritis
- previous knee infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Bærum Sykehus
Bærum, Akershus, 1309, Norway
Akershus University Hospital
Lørenskog, Akershus, 1478, Norway
Martina Hansens Hospital
Bærum, Bærum, 1306, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tor Kjetil Nerhus
- Organization
- Martina Hansens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Tor Kjetil Nerhus, MD
Martina Hansens Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Orthopaedic surgeon
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 15, 2009
Study Start
November 1, 2003
Primary Completion
February 1, 2009
Study Completion
February 1, 2017
Last Updated
December 1, 2023
Results First Posted
January 13, 2015
Record last verified: 2023-11