Determinants of Early Functional Outcome After Reconstructive Surgery
Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery
1 other identifier
observational
36
1 country
1
Brief Summary
This exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2015
1 active site
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
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 7, 2017
March 1, 2017
1.1 years
February 28, 2015
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Knee Injury and Osteoarthritis Score (KOOS)
Self reported questionnaire which evaluates pain, other symptoms, function in activity of daily living, function in sport and recreation (Sport/Rec), and knee related QoL.
from 10 weeks prior to surgery to 12 weeks after surgery
Oxford knee score (OKS)
Self reported questionnaire which evaluates pain and function.
from 10 weeks prior to surgery to 12 weeks after surgery
Postural stability as assesed by force plate
Postural stability will be assessed using a stable force plate.
from 10 weeks prior to surgery to 12 weeks after surgery
Secondary Outcomes (6)
Neuromuscular performance capability
from 10 weeks prior to surgery to 12 weeks after surgery
Sensorimotor performance capability
from 10 weeks prior to surgery to 12 weeks after surgery
International Physical Activity Questionnaire (IPAQ).
from 10 weeks prior to surgery to 12 weeks after surgery
Knee circumference
from 10 weeks prior to surgery to 12 weeks after surgery
DNA genotypes and subsequent protein expression
on the day of surgery and 12 weeks following operation
- +1 more secondary outcomes
Eligibility Criteria
Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary total knee arthroplasty (TKA).
You may qualify if:
- Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.
You may not qualify if:
- Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis
- Rheumatic disorder
- Other orthopaedic conditions affecting lower body function
- Neurological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG, United Kingdom
Biospecimen
blood serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria A Peer
Queen Margaret University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Research Student
Study Record Dates
First Submitted
February 28, 2015
First Posted
March 6, 2015
Study Start
February 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 7, 2017
Record last verified: 2017-03